MISDexa: Mini Stem DEXA (Dual Energy X-ray Absorptiometry)

• Sponsor: Smith & Nephew, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01066936
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 79.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the bone ingrowth after implantation of the study device. This study will also document any device-related surgical complications or adverse radiographic observations. Improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Hip

Detailed Description

The purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using Dual Energy X-ray Absorptiometry (DEXA). The intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Bone Density by Dual Energy X-ray Absorptiometry (DEXA) Following Total Hip Arthroplasty With the "Short Mini Stem"
• Actual Study Start Date: Sep 14, 2009
• Actual Primary Completion Date: Apr 18, 2016
• Actual Study Completion Date: Apr 18, 2016

Outcome Measures

Primary Outcome Measures

1. DEXA Analysis of BMD at Preoperative Visit [Preoperative]

   DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

2. DEXA Analysis of BMD at 3 Months [3 Months]

   DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

3. DEXA Analysis of BMD at 6 Months [6 Months]

   DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

4. DEXA Analysis of BMD at 1 Year [1 Year]

   DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

5. DEXA Analysis of BMD at 2 Years [2 Year]

   DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.

Secondary Outcome Measures

1. Baseline Harris Hip Score (HHS) at Preoperative Visit [Preoperative]

   The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.

2. Harris Hip Score (HHS) at 3 Month Visit [3 Month]

   The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.

3. Harris Hip Score (HHS) at 6 Month Visit [6 Months]

   The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.

4. Harris Hip Score (HHS) at 1 Year Visit [1 Year]

   The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.

5. Harris Hip Score (HHS) at 2 Year Visit [2 Years]

   The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.

6. Harris Hip Score (HHS) at 5 Year Visit [5 Year]

   The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.

7. Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit [Preoperative]

   The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.

8. Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit [3 Months]

   The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.

9. Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit [6 Months]

   The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.

10. Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit [1 Year]

    The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.

11. Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit [2 Years]

    The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.

12. Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit [5 Years]

    The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.

13. Radiographic Assessment at Preoperative Visit (Yes/No Components) [Discharge]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip

14. Radiographic Assessment at 3 Month Visit (Yes/No Components) [3 Months]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip

15. Radiographic Assessment at 1 Year Visit (Yes/No Components) [1 Year]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip

16. Radiographic Assessment at 5 Year Visit (Yes/No Components) [5 Year]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip

17. Radiographic Assessment at Discharge Visit [Discharge]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

18. Radiographic Assessment at 3 Month Visit [3 Months]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

19. Radiographic Assessment at 1 Year Visit [1 Year]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

20. Radiographic Assessment at 5 Year Visit [5 Year]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

21. Radiographic Assessment at Discharge Visit (Neutral/Valgus Component) [Discharge]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

22. Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component) [3 Months]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

23. Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component) [1 Year]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

24. Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component) [5 Years]

    Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has hip disease that requires a total hip arthroplasty.

• Patient is willing to consent to participate in the study.

• Patient plans to be available for the study duration.

• Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.

Exclusion Criteria:

• Patient known to have insufficient bone stock.

• Patient has had major non-arthroscopic surgery to the study hip.

• Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.

• Patient has a known sensitivity to materials in the device.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malabar Orthopaedic Clinic	Windsor		Australia	3181

Sponsors and Collaborators

• Smith & Nephew, Inc.

Investigators

• Principal Investigator: Steve McMahon, MD, Malabar Orthopaedic Clinic
• Study Chair: Beate Hanson, MD, PhD, Vice Presidient, Global Clinical Strategy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT01066936
• Other Study ID Numbers: 2090SMFH131
• First Posted: Feb 10, 2010
• Last Update Posted: Mar 6, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Osteoarthritis, Hip

Study Results

Participant Flow

Recruitment Details	This study was conducted by 1 investigator in 1 country from 14 Sep 2009 to 18 Apr 2016.
Pre-assignment Detail	A total of 22 subjects were screened, with 20 subjects enrolled and had surgery/MIS implanted.

Arm/Group Title	MIS (Mini Stem) Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during total hip arthroplasty (THA).
Period Title: Overall Study
STARTED	20
COMPLETED	10
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. All subjects had implantation of the MIS femoral stem/modular neck during THA. DEXA was used to assess the bone ingrowth and detect significant alterations in skeletal structure that may not be visible during routine clinical assessment.
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.8 (9.63)
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	19 95%
European	1 5%
Region of Enrollment (participants) [Number]
Australia	20 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	170.2 (7.39)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	90.8 (12.39)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.3 (3.69)
Primary Diagnosis Charnley Classification (Count of Participants)
Avascular necrosis: B1 Bilateral Hip Joint Disease	1 5%
Osteoarthritis: A Unilateral Hip Joint Disease	14 70%
Osteoarthritis: B1 Bilateral Hip Joint Disease	4 20%
Rheumatoid arthritis:C1 Multi-joint arthroplasties	1 5%

Outcome Measures

1. Primary Outcome

Title	DEXA Analysis of BMD at Preoperative Visit
Description	DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time Frame	Preoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Femoral Region 1	0.8 (0.22)
Femoral Region 2	1.0 (0.25)
Femoral Region 3	1.6 (0.31)
Femoral Region 4	2.0 (0.32)
Femoral Region 5	1.8 (0.33)
Femoral Region 6	1.3 (0.29)
Femoral Region 7	1.4 (0.31)

2. Primary Outcome

Title	DEXA Analysis of BMD at 3 Months
Description	DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Population
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Femoral Region 1	0.8 (0.18)
Femoral Region 2	1.3 (0.26)
Femoral Region 3	2.1 (0.39)
Femoral Region 4	1.9 (0.27)
Femoral Region 5	1.9 (0.27)
Femoral Region 6	1.5 (0.32)
Femoral Region 7	1.3 (0.27)

3. Primary Outcome

Title	DEXA Analysis of BMD at 6 Months
Description	DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Population
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Femoral Region 1	0.8 (0.19)
Femoral Region 2	1.3 (0.31)
Femoral Region 3	2.1 (0.38)
Femoral Region 4	1.9 (0.30)
Femoral Region 5	2.0 (0.28)
Femoral Region 6	1.6 (0.30)
Femoral Region 7	1.2 (0.35)

4. Primary Outcome

Title	DEXA Analysis of BMD at 1 Year
Description	DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Population
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Femoral Region 1	0.8 (0.20)
Femoral Region 2	1.3 (0.29)
Femoral Region 3	2.1 (0.41)
Femoral Region 4	1.9 (0.30)
Femoral Region 5	1.9 (0.31)
Femoral Region 6	1.6 (0.37)
Femoral Region 7	1.3 (0.30)

5. Primary Outcome

Title	DEXA Analysis of BMD at 2 Years
Description	DEXA=Dual Energy X-Ray Absorptiometry; BMD=Bone Mineral Density; The proximal femur was divided into 7 regions relative to the length of the stem. Lateral portions = region 1, region 2 and region 3; The entire bone mass immediately distal to the stem tip = region 4; Medial portions = region 5, region 6, and region 7. Mean BMD was calculated for each femoral region. BMD values were adjusted peri-prosthetically to account for stem area.
Time Frame	2 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Study Population
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	19
Femoral Region 1	0.8 (0.21)
Femoral Region 2	1.3 (0.33)
Femoral Region 3	2.2 (0.31)
Femoral Region 4	1.9 (0.29)
Femoral Region 5	2.0 (0.32)
Femoral Region 6	1.6 (0.39)
Femoral Region 7	1.3 (0.25)

6. Secondary Outcome

Title	Baseline Harris Hip Score (HHS) at Preoperative Visit
Description	The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time Frame	Preoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Pain	17.0 (7.33)
Function	26.0 (7.58)
Absence of Deformity	3.8 (0.89)
Range of Motion	2.7 (0.86)
Total	49.5 (13.53)

7. Secondary Outcome

Title	Harris Hip Score (HHS) at 3 Month Visit
Description	The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time Frame	3 Month

Outcome Measure Data

Analysis Population Description

Overall number of participants analyzed was 20 particpants; however, for the Function and Total Overall portion of the questionnaire only 18 participants responded.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Pain	37.5 (9.56)
Function	35.1 (5.60)
Absence of Deformity	4.0 (0.00)
Range of Motion	4.1 (0.69)
Total	82.6 (10.15)

8. Secondary Outcome

Title	Harris Hip Score (HHS) at 6 Month Visit
Description	The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Pain	40.8 (5.29)
Function	41.2 (5.67)
Absence of Deformity	4.0 (0.00)
Range of Motion	4.2 (0.37)
Total	90.1 (7.22)

9. Secondary Outcome

Title	Harris Hip Score (HHS) at 1 Year Visit
Description	The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

Two subjects were missing results from the study site for the HHS.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	17
Pain	38.0 (9.27)
Function	41.5 (7.14)
Absence of Deformity	4.0 (0.00)
Range of Motion	4.5 (0.62)
Total	87.3 (16.13)

10. Secondary Outcome

Title	Harris Hip Score (HHS) at 2 Year Visit
Description	The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Number of participants returning for this time point visit assessment.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	11
Pain	40.7 (7.11)
Function	41.9 (5.79)
Absence of Deformity	4.0 (0.00)
Range of Motion	4.0 (0.45)
Total	90.6 (11.57)

11. Secondary Outcome

Title	Harris Hip Score (HHS) at 5 Year Visit
Description	The HHS is a physician tool to measure how a subject is doing following hip replacement surgery using the following scale: Total Scale Ranges: Excellent: 90 - 100 Good: 80 - 89 Fair: 70 - 79 Poor: 60 - 69 Very Poor: <60 Subscore Ranges: Pain: 0 - 44 Function: 0 - 47 Absence of Deformity: 0 - 4 Range of Motion: 0 - 5 The score ranges from 0 to 100, where, the higher the score, the better the subject outcome. Lower scores indicate a higher level of dysfunction due to hip problems.
Time Frame	5 Year

Outcome Measure Data

Analysis Population Description

Number of participants returning for this time point visit assessment.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	9
Pain	43.6 (1.33)
Function	45.8 (1.48)
Absence of Deformity	4.0 (0.00)
Range of Motion	4.3 (0.50)
Total	97.7 (2.45)

12. Secondary Outcome

Title	Hip Injury Osteoarthritis Outcome Score (HOOS) at Preoperative Visit
Description	The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time Frame	Preoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Symptoms and Stiffness	52.8 (18.53)
Pain	49.1 (17.50)
Daily Living	44.7 (17.19)
Sports/Recreational Activities	22.1 (19.98)
Quality of Life	24.7 (14.97)

13. Secondary Outcome

Title	Hip Injury Osteoarthritis Outcome Score (HOOS) at 3 Month Visit
Description	The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Symptoms and Stiffness	83.0 (13.42)
Pain	88.8 (13.39)
Daily Living	84.8 (12.29)
Sports/Recreational Activities	76.0 (22.70)
Quality of Life	73.1 (22.86)

14. Secondary Outcome

Title	Hip Injury Osteoarthritis Outcome Score (HOOS) at 6 Month Visit
Description	The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

Information was not provided from the study site for two subjects in the HOOS Sports/Recreational Activities (0-100) category.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	20
Symptoms and Stiffness	93.0 (10.31)
Pain	94.2 (7.82)
Daily Living	93.0 (6.80)
Sports/Recreational Activities	80.4 (17.37)
Quality of Life	83.8 (14.68)

15. Secondary Outcome

Title	Hip Injury Osteoarthritis Outcome Score (HOOS) at 1 Year Visit
Description	The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

Number of participants returning for this time point visit assessment.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	16
Symptoms and Stiffness	90.0 (14.14)
Pain	89.2 (14.54)
Daily Living	87.8 (15.62)
Sports/Recreational Activities	78.3 (28.8)
Quality of Life	82.4 (25.13)

16. Secondary Outcome

Title	Hip Injury Osteoarthritis Outcome Score (HOOS) at 2 Year Visit
Description	The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Number of participants returning for this time point visit assessment. Information was not provided from the study site for 1 subject in the HOOS Sports/Recreational Activities (0-100) and Quality of Life (0-100) categories.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	14
Symptoms and Stiffness	90.7 (8.05)
Pain	92.5 (10.28)
Daily Living	89.9 (12.54)
Sports/Recreational Activities	81.6 (20.60)
Quality of Life	81.7 (22.74)

17. Secondary Outcome

Title	Hip Injury Osteoarthritis Outcome Score (HOOS) at 5 Year Visit
Description	The HOOS is a questionnaire that the subject completes focusing on hip pain, stiffness, and function relating to osteoarthritis of the hip. The HOOS consists of 40 items assessing 5 subscales. The 5 separate patient-relevant dimensions are Symptoms and Stiffness, Pain, Function in Daily Living, Function in Sport and Recreation, and Hip-Related Quality of Life (QoL). Pain includes 10 items with a total score of 0 - 100 points Symptoms includes 5 items with a total score of 0 - 100 points Function in Daily Living includes 17 items with a total score of 0 - 100 points Function in Sport and Recreation and Hip-Related QoL each include 4 items with a total score of 0 - 100 points. Each sub-score was transformed in a worst to best scale (0-100), where 100 indicates no symptoms and 0 indicates extreme symptoms.
Time Frame	5 Years

Outcome Measure Data

Analysis Population Description

Information was not provided from the study site for 1 subject in the HOOS Pain (0-100), Daily Living (0-100), Sports/Recreational Activities (0-100), and Quality of Life (0-100) categories.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted.
Measure Participants	10
Symptoms and Stiffness	96.5 (6.69)
Pain	98.3 (4.15)
Daily Living	97.2 (5.27)
Sports/Recreational Activities	85.6 (21.91)
Quality of Life	95.8 (6.99)

18. Secondary Outcome

Title	Radiographic Assessment at Preoperative Visit (Yes/No Components)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
Time Frame	Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Yes	20 100%
No	0 0%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%

19. Secondary Outcome

Title	Radiographic Assessment at 3 Month Visit (Yes/No Components)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Yes	20 100%
No	0 0%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%

20. Secondary Outcome

Title	Radiographic Assessment at 1 Year Visit (Yes/No Components)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Yes	19 95%
No	1 5%
Yes	0 0%
No	20 100%
Yes	1 5%
No	19 95%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%
Yes	0 0%
No	20 100%

21. Secondary Outcome

Title	Radiographic Assessment at 5 Year Visit (Yes/No Components)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view. The span of the bone-prosthesis interface for each component was broken down into zone systems. The scoring system was based on the measurement of radiolucent lines (in millimeters) in each zone. The checklist reviewed radiolucencies, migration, osteolysis, and stress shielding. The Brooker Classification was defined as: Class 0 - absence of radiographic heterotopic ossification Class 1 - islands of bone within soft tissues Class 2 - bone spurs originating from pelvis or proximal end of femur with at least 1 cm between opposing bone surfaces Class 3 - bone spurs originating from pelvis or proximal end of femur reduced to <1 cm Class 4 - apparent bone ankyloses of the hip
Time Frame	5 Year

Outcome Measure Data

Analysis Population Description

All participants available at this time point visit assessment.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	10
Yes	10 50%
No	0 0%
Yes	0 0%
No	10 50%
Yes	0 0%
No	10 50%
Yes	0 0%
No	10 50%
Yes	0 0%
No	10 50%
Yes	0 0%
No	10 50%

22. Secondary Outcome

Title	Radiographic Assessment at Discharge Visit
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Femoral Valgus Position Degree	0 (0)
Acetabular Component Position Degree	40.9 (3.44)

23. Secondary Outcome

Title	Radiographic Assessment at 3 Month Visit
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Femoral Valgus Position Degree	0 (0)
Acetabular Component Position Degree	41.3 (2.90)

24. Secondary Outcome

Title	Radiographic Assessment at 1 Year Visit
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Femoral Valgus Position Degree	0 (0)
Acetabular Component Position Degree	41.3 (2.90)

25. Secondary Outcome

Title	Radiographic Assessment at 5 Year Visit
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	5 Year

Outcome Measure Data

Analysis Population Description

All available subjects participating in this time point visit assessment.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Femoral Valgus Position Degree	10.5 (2.12)
Acetabular Component Position Degree	40.6 (3.41)

26. Secondary Outcome

Title	Radiographic Assessment at Discharge Visit (Neutral/Valgus Component)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Neutral	20 100%
Valgus	0 0%

27. Secondary Outcome

Title	Radiographic Assessment at 3 Month Visit (Neutral/Valgus Component)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	3 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Neutral	20 100%
Valgus	0 0%

28. Secondary Outcome

Title	Radiographic Assessment at 1 Year Visit (Neutral/Valgus Component)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	20
Neutral	20 100%
Valgus	0 0%

29. Secondary Outcome

Title	Radiographic Assessment at 5 Year Visit (Neutral/Valgus Component)
Description	Radiographs were obtained from the anteroposterior (AP) view as well as the lateral view.
Time Frame	5 Years

Outcome Measure Data

Analysis Population Description

All available subjects participating in this time point visit assessment.

Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
Measure Participants	10
Neutral	8 40%
Valgus	2 10%

Adverse Events

Time Frame	The time frame for collection of AEs is from the signing of the Informed Consent through Study Exit, an average of 5 years.
Adverse Event Reporting Description	Device-related adverse events are defined as any of the following: any device implant component failure including any of the following exact or similar descriptive nomenclature: a) revision, fracture, crack, chip, flake, split, splinter, shatter, break, or wear-through; b) device wear particle induced osteolysis, inflammation, etc. (wear debris may be metal and/or UHMWPE in composition); and c) any device component experiencing dislocation, subluxation, subsidence, migration, or loosening.
Arm/Group Title	MIS Stem
Arm/Group Description	Patients with non-inflammatory and inflammatory degenerative joint disease (DJD) who required a primary total hip replacement (THR) and had the MIS femoral stem/modular neck implanted. There was no assignment of study treatment: all subjects had implantation of the MIS femoral stem/modular neck during THA.
All Cause Mortality
	MIS Stem
	Affected / at Risk (%)	# Events
Total	2/20 (10%)
Serious Adverse Events
	MIS Stem
	Affected / at Risk (%)	# Events
Total	13/20 (65%)
Congenital, familial and genetic disorders
Atrial fibrillation	1/20 (5%)	1
Gastrointestinal disorders
Cholecystectomy	1/20 (5%)	1
Bleeding gastric ulcer	1/20 (5%)	1
General disorders
Death	2/20 (10%)	2
Injury, poisoning and procedural complications
Cut hand - hospital admission for intervenous (IV) antibiotics	1/20 (5%)	1
Pain on weight-bearing lower thigh	1/20 (5%)	1
Musculoskeletal and connective tissue disorders
Contralateral THR secondary to osteoarthritis (OA)	2/20 (10%)	2
Unicompartmental knee replacement secondary to OA	2/20 (10%)	3
Osteolysis region 1, 3-7 on radiograph	1/20 (5%)	1
Nervous system disorders
Alzheimer's Disease	1/20 (5%)	1
Product Issues
Subsidence of femoral prosthesis; revision in THR	1/20 (5%)	1
Dislocation THR	1/20 (5%)	2
Other (Not Including Serious) Adverse Events
	MIS Stem
	Affected / at Risk (%)	# Events
Total	14/20 (70%)
Cardiac disorders
Paroxysmal Atrial fibrillation	1/20 (5%)	1
Injury, poisoning and procedural complications
Sprained Adductors	1/20 (5%)	1
Metabolism and nutrition disorders
Newly diagnosed hypoparathyroidism	1/20 (5%)	1
Musculoskeletal and connective tissue disorders
Cortical thickening region 3	11/20 (55%)	11
Mild sclerosis over weight-bearing aspect of acetabulum on x-ray	1/20 (5%)	1
Adductor tendonitis	1/20 (5%)	1
Osteoarthritis	2/20 (10%)	2
Hip pain	1/20 (5%)	1
Thigh and trochanteric pain	2/20 (10%)	2
Condensation around tip of stem on x-ray femur	1/20 (5%)	1
Trochanteric pain	1/20 (5%)	1

Limitations/Caveats

There was a decreased compliance rate at the 3 year follow-up and a 50% termination rate by the 5 year follow-up resulting in a much smaller sample sizes for data collection.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.