Trident® X3 Polyethylene Insert Study

• Sponsor: Stryker Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00958191
• Collaborator: (none)
• Enrollment: 250
• Locations: 9
• Arm: 1
• Duration (Months): 139
• Patients Per Site: 27.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Hip	Device: Trident® X3 Polyethylene Insert	N/A

Detailed Description

The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.

Study Design

• Study Type: Interventional
• Actual Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Prospective, Post-market, Historically Controlled, Multi-center Clinical Evaluation of the Trident® X3 Polyethylene Acetabular Inserts.
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Trident® X3 Polyethylene Insert Participants who received the Trident® X3 Polyethylene Insert.	Device: Trident® X3 Polyethylene Insert; Trident® X3 Polyethylene Insert

Outcome Measures

Primary Outcome Measures

1. Mean Linear Wear Rate at 5 Years [5 years]

   Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years

2. Rate of Incidence of Revision of Component for Any Reason [5 year]

   Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.

Secondary Outcome Measures

1. Linear Wear Rate of the Trident X3 Polyethylene Insert [2, 3 and 4 year films collected; 3 and 4 year wear assessed]

   Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.

2. Volumetric Wear Rate of the Trident X3 Polyethylene Insert [2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed]

   Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.

3. Radiographic Stability [1,2,3,4 and 5 years]

   Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.

4. Mean Harris Hip Score (HHS) to Assess Change [pre-operative, 1,3 and 5 years]

   The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor

5. Mean Harris Hip Score (HHS) Pain Score to Assess Change [pre-operative, 1,3, and 5 years]

   The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored. None or ignores it = 44 points Slight, occasional, no compromise in activities = 40 points Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points Marked pain, serious limitation of activites = 10 points Totally disabled, crippled, pain in bed, bedridden = 0 points

6. Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change [pre-operative, 1,3 and 5 years]

   The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5. 211-300 degrees = 5 points 161 to 210 degrees = 4 points 101 to 160 degrees = 3 points 61 to 100 degrees = 2 points 31 to 60 degrees = 1 points 0 to 30 degrees = 0 points

7. Mean SF-12 Health Survey Score to Assess Change [pre-operative, 1,3 and 5 years]

   Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.

8. Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change [pre-operative, 1,3 and 5 years]

   Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.

9. Implant Survivorship [10 years]

   Implant survivorship is determined using the Kaplan-Meier method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The patient has signed an IRB-approved, study specific Patient Informed Consent Form.

2. The patient is a candidate for a primary total hip replacement with cementless acetabular and femoral components.

3. The patient has a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant.

4. The patient is a male or non-pregnant female patient ages 21 to 75.

5. The patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. The patient has an active infection with the affected hip joint.

2. The patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.

3. The patient has a BMI >45.

4. The patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.

5. The patient has diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).

6. The patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.

7. The patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.

8. The patient is a prisoner.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30329
2	Bonutti Research Inc.	Effingham	Illinois	United States	62401
3	Indiana University	Indianapolis	Indiana	United States	46202-5111
4	New England Baptist Hospital	Boston	Massachusetts	United States	02120
5	J. Wesley Mesko, MD	Lansing	Michigan	United States	48910
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	Good Samaritan Hospital	Kearney	Nebraska	United States	68845
8	Greater Pittsburgh Orthopaedics Assoc	Pittsburgh	Pennsylvania	United States	15108-4305
9	University of Vermont College of Medicine	Burlington	Vermont	United States	05405

Sponsors and Collaborators

• Stryker Orthopaedics

Investigators

• Study Chair: James D'Antonio, MD, Greater Pittsburgh Orthopaedic Association
• Principal Investigator: Benjamin Bierbaum, MD, New England Baptist Hospital Deptartment of Orthopaedics
• Principal Investigator: Peter Bonutti, MD, Bonutti Clinic
• Principal Investigator: William Capello, MD, Indiana University School of Medicine
• Principal Investigator: Michael Taunton, MD, Mayo Clinic Department of Orthopaedic Surgery
• Principal Investigator: Robert Johnson, MD, University of Vermont College of Medicine Department of Orthopaedics & Rehabilitation
• Principal Investigator: J. Wesley Mesko, MD, Michigan Orthopaedic Center
• Principal Investigator: James R Roberson, MD, Emory Orthopaedics
• Principal Investigator: John Wright, MD, New West Orthopaedics
• Principal Investigator: Daniel Ward, MD, New England Baptist Hospital Department of Orthopaedics
• Principal Investigator: Russell Meldrum, MD, Indiana University School of Medicine
• Principal Investigator: J. Andrew Parr, MD, Indiana University School of Medicine
• Principal Investigator: Steven Incavo, MD, University of Vermont
• Principal Investigator: Greg Erens, MD, Emory Orthopaedics
• Principal Investigator: Robert Trousdale, MD, Mayo Clinic Department of Orthopaedic Surgery
• Principal Investigator: Alren Hanssen, MD, Mayo Clinic Department of Orthopaedic Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stryker Orthopaedics
• ClinicalTrials.gov Identifier: NCT00958191
• Other Study ID Numbers: 57
• First Posted: Aug 13, 2009
• Last Update Posted: Feb 23, 2018
• Last Verified: Jan 1, 2018

Study Results

Participant Flow

Recruitment Details	For bilateral hip replacement participants, if one hip completed primary endpoint #1 the participant is counted as completed. If one hip was censored, but the other hip was not, the hip is counted as censored, but the participant is not.
Pre-assignment Detail	250 participants/271 hips enrolled - 29 participants/31 hips censored= 221 participants/240 hips followed. There were 5 revisions, but one bilateral participant had one hip revised and the other hip completed the primary endpoint. This participant is counted as completed and not in the revision category.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
Period Title: Overall Study
STARTED	221
COMPLETED	110
NOT COMPLETED	111

Baseline Characteristics

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	All subjects who recieved the Trident X3 insert.
Overall Participants	221
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.04 (8.74)
Sex: Female, Male (Count of Participants)
Female	116 52.5%
Male	105 47.5%
Region of Enrollment (Count of Participants)
United States	221 100%

Outcome Measures

1. Primary Outcome

Title	Mean Linear Wear Rate at 5 Years
Description	Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received theTrident® X3 Polyethylene Insert
Measure Participants	110
Measure Hips	118
Mean (Standard Deviation) [mm/year]	0.016 (0.068)

2. Primary Outcome

Title	Rate of Incidence of Revision of Component for Any Reason
Description	Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head.
Time Frame	5 year

Outcome Measure Data

Analysis Population Description

Difference of 5 participants from the participant flow completed (=110): 4 participants are included in the revision category of the participant flow and one participant had revision of only the femoral head & stem but later withdrew from the study & is included in the withdrawal category of the participant flow.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	115
Measure Hips	124
Number [percentage of hips undergoing revision]	4.84

3. Secondary Outcome

Title	Linear Wear Rate of the Trident X3 Polyethylene Insert
Description	Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.
Time Frame	2, 3 and 4 year films collected; 3 and 4 year wear assessed

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	140
Measure Hips	149
3 year mean wear rate	0.022 (0.133)
4 year mean wear rate	0.024 (0.087)

4. Secondary Outcome

Title	Volumetric Wear Rate of the Trident X3 Polyethylene Insert
Description	Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear.
Time Frame	2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	140
Measure Hips	149
3 year volumetric wear rate	17.9
4 year volumetric wear rate	19.1
5 year volumetric wear rate	13.3

5. Secondary Outcome

Title	Radiographic Stability
Description	Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years.
Time Frame	1,2,3,4 and 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the 1 year population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	197
Measure Hips	214
Radiographically unstable at 1 year	0
Radiographically unstable at 2 years	0
Radiographically unstable at 3 years	0
Radiographically unstable at 4 years	0
Radiographically unstable at 5 years	0

6. Secondary Outcome

Title	Mean Harris Hip Score (HHS) to Assess Change
Description	The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor
Time Frame	pre-operative, 1,3 and 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	217
Measure Hips	236
HHS Mean Preoperative Score	53.01 (13.68)
HHS Mean 1 Year Score	94.41 (8.75)
HHS Mean 3 Year Score	95.32 (8.32)
HHS Mean 5 year Score	94.05 (8.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in HHS from pre-op to 1 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in HHS from pre-op to 3 years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in HHS from pre-op to 5 years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

7. Secondary Outcome

Title	Mean Harris Hip Score (HHS) Pain Score to Assess Change
Description	The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored. None or ignores it = 44 points Slight, occasional, no compromise in activities = 40 points Mild pain, no effect on average activities, rarely moderate pain with unusual activity;may take aspirin = 30 points Moderate pain, tolerable, but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medication stronger than aspirin = 20 points Marked pain, serious limitation of activites = 10 points Totally disabled, crippled, pain in bed, bedridden = 0 points
Time Frame	pre-operative, 1,3, and 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	221
Measure Hips	240
HHS Pain Mean Preoperative Score	16.73 (8.24)
HHS Pain Mean 1 Year Score	41.52 (5.64)
HHS Pain Mean 3 Year Score	42.50 (4.89)
HHS Pain Mean 5 Year Score	41.75 (5.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in Harris Hip Pain Score from pre-op to 1 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in Harris Hip Pain Score from pre-op to 3 years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in Harris Hip Pain Score from pre-op to 5 years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

8. Secondary Outcome

Title	Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change
Description	The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5. 211-300 degrees = 5 points 161 to 210 degrees = 4 points 101 to 160 degrees = 3 points 61 to 100 degrees = 2 points 31 to 60 degrees = 1 points 0 to 30 degrees = 0 points
Time Frame	pre-operative, 1,3 and 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	221
Measure Hips	240
HHS ROM Mean Preoperative Score	3.90 (0.95)
HHS ROM Mean 1 Year Score	4.99 (0.12)
HHS ROM Mean 3 Year Score	4.99 (0.11)
HHS ROM Mean 5 Year Score	4.93 (0.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in Harris Hip ROM score from pre-op to 1 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in Harris Hip ROM score from pre-op to 3 years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in Harris Hip ROM score from pre-op to 5 years
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

9. Secondary Outcome

Title	Mean SF-12 Health Survey Score to Assess Change
Description	Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time Frame	pre-operative, 1,3 and 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	215
Measure Hips	233
Mean SF-12 Physical Score Preoperative	32.11 (8.86)
Mean SF-12 Physical Score 1 year	49.90 (8.51)
Mean SF-12 Physical Score 3 years	49.97 (8.74)
Mean SF-12 Physical Score 5 years	49.08 (8.38)
Mean SF-12 Mental Score Preoperative	53.75 (10.91)
Mean SF-12 Mental Score 1 year	55.72 (7.83)
Mean SF-12 Mental Score 3 years	55.78 (8.13)
Mean SF-12 Mental Score 5 years	54.88 (7.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in SF-12 Phyiscal Component Score from preop to 1 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in SF-12 Phyiscal Component Score from preop to 3 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in SF-12 Phyiscal Component Score from preop to 5 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in SF-12 Mental Component Score from preop to 1 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0242
	Comments
	Method	Sign test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in SF-12 Mental Component Score from preop to 3 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0247
	Comments
	Method	Sign test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in SF-12 Mental Component Score from preop to 5 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1372
	Comments
	Method	Sign test
	Comments

10. Secondary Outcome

Title	Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change
Description	Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time Frame	pre-operative, 1,3 and 5 years

Outcome Measure Data

Analysis Population Description

Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	221
Measure Hips	240
Mean LEAS score Preoperative	8.95 (2.54)
Mean LEAS score 1 year	11.65 (3.01)
Mean LEAS score 3 years	11.69 (2.95)
Mean LEAS score 5 years	10.92 (2.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in LEAS Score from preop to 1 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in LEAS Score from preop to 3 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Sign test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Trident® X3 Polyethylene Insert
	Comments	Change in LEAS Score from preop to 5 year
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Implant Survivorship
Description	Implant survivorship is determined using the Kaplan-Meier method.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

Participants with available data. The population includes all 240 cases who were initially consented to 5 year study. There are 127 cases who consented to continue in the 10 year study.

Arm/Group Title	Trident® X3 Polyethylene Insert
Arm/Group Description	Participants who received the Trident® X3 Polyethylene Insert.
Measure Participants	221
Measure hips	240
Kaplan-Meier Estimate (based on 5 year cases)	95.79
Kaplan-Meier Estimate (based on 10 year cases)	98.37

Adverse Events

Time Frame	To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Adverse Event Reporting Description	Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular & bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion & mid-foot/flat-foot surgery.
Arm/Group Title	Operative Adverse Events		Non-operative Adverse Events
Arm/Group Description	Trident X3 Polyethylene Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason.		Trident X3 Polyethylene Insert. Non-operative site events are reported by participant.
All Cause Mortality
	Operative Adverse Events		Non-operative Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Operative Adverse Events		Non-operative Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/240 (5%)		33/221 (14.9%)
Cardiac disorders
Non-operative Site	0/0 (NaN)	0	3/221 (1.4%)	3
Gastrointestinal disorders
Non-operative Site	0/0 (NaN)	0	1/221 (0.5%)	1
General disorders
Non-operative Site	0/0 (NaN)	0	1/221 (0.5%)	1
Hepatobiliary disorders
Non-operative Site	0/0 (NaN)	0	1/221 (0.5%)	1
Infections and infestations
Operative Site	1/240 (0.4%)	1	0/0 (NaN)	0
Non-operative Site	0/0 (NaN)	0	4/221 (1.8%)	4
Injury, poisoning and procedural complications
Operative Site	1/240 (0.4%)	1	0/0 (NaN)	0
Musculoskeletal and connective tissue disorders
Operative Site	11/240 (4.6%)	19	0/0 (NaN)	0
Non-operative Site	0/0 (NaN)	0	13/221 (5.9%)	14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-operative Site	0/0 (NaN)	0	4/221 (1.8%)	4
Nervous system disorders
Operative Site	1/240 (0.4%)	1	0/0 (NaN)	0
Non-operative Site	0/0 (NaN)	0	1/221 (0.5%)	1
Psychiatric disorders
Non-operative Site	0/0 (NaN)	0	1/221 (0.5%)	1
Renal and urinary disorders
Non-operative Site	0/0 (NaN)	0	3/221 (1.4%)	3
Respiratory, thoracic and mediastinal disorders
Non-operative Site	0/0 (NaN)	0	1/221 (0.5%)	1
Vascular disorders
Non-operative Site	0/0 (NaN)	0	2/221 (0.9%)	2
Other (Not Including Serious) Adverse Events
	Operative Adverse Events		Non-operative Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	62/240 (25.8%)		65/221 (29.4%)
Blood and lymphatic system disorders
Non-operative Site	0/0 (NaN)	0	17/221 (7.7%)	17
Infections and infestations
Non-operative Site	0/0 (NaN)	0	13/221 (5.9%)	15
Injury, poisoning and procedural complications
Operative Site	19/240 (7.9%)	19	0/0 (NaN)	0
Musculoskeletal and connective tissue disorders
Operative Site	45/240 (18.8%)	55	0/0 (NaN)	0
Non-operative Site	0/0 (NaN)	0	41/221 (18.6%)	50

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts and abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.