Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component

• Sponsor: Medacta International SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01285843
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Arthritis; Avascular Necrosis; Fracture of the Femoral Neck or Head; Congenital Hip Dysplasia	Procedure: Anterior Minimally Invasive Approach (AMIS)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component.
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Quadra Group	Procedure: Anterior Minimally Invasive Approach (AMIS)
Active Comparator: AMIStem Group	Procedure: Anterior Minimally Invasive Approach (AMIS)

Outcome Measures

Primary Outcome Measures

1. Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component. [0-12 months]

Secondary Outcome Measures

1. Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score [6 weeks, 6 months, 1 year]

   The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity. The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.

2. Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score. [6 months, 1 year]

   The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.

3. Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components. [6 months, 1 year]

   Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.

• Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)).

• Patients must be willing to comply with the pre and post-operative evaluation schedule.

• Patients with only one lower limb arthroplasty

Exclusion Criteria:

• Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism

• Patients with osteoporosis (pre-op T-score < -2,5)

• Patients with significant comorbidities

• Patients with both hip and knee arthroplasty

• Patients with restricted mobility

• Patient with severe hip contracture

• Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Elisabeth Dillingen	Dillingen an der Donau	Bayern	Germany	89407

Sponsors and Collaborators

• Medacta International SA

Investigators

• Principal Investigator: Martin Nolde, Dr. Med., DGOOC; BVO; BVASK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01285843
• Other Study ID Numbers: P01.004.14
• First Posted: Jan 28, 2011
• Last Update Posted: Oct 20, 2016
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Necrosis

Study Results

Participant Flow

Arm/Group Title	Quadra Group	AMIStem Group
Arm/Group Description	Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)	Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
Period Title: Overall Study
STARTED	20	20
COMPLETED	18	18
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Quadra Group	AMIStem Group	Total
Arm/Group Description	Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)	Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (9)	64 (9.6)	66 (9.4)
Sex: Female, Male (Count of Participants)
Female	11 55%	12 60%	23 57.5%
Male	9 45%	8 40%	17 42.5%

Outcome Measures

1. Primary Outcome

Title	Compare Periprosthetic Bone Mineral Density (BMD), at 1y Postoperative, in Patients That Have Undergone a Total Hip Arthroplasty (THA) Via the Direct Anterior Approach Receiving Either a Quadra or AMIStem Femoral Component.
Time Frame	0-12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quadra Group	AMIStem Group
Arm/Group Description	Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)	Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
Measure Participants	18	18
1y postop BMD Gruen zone 1 minus baseline	-0.04 (0.10)	0.01 (0.13)
1y postop BMD Gruen zone 2 minus baseline	-0.04 (0.14)	0.05 (0.17)
1y postop BMD Gruen zone 3 minus baseline	0 (0.15)	0.01 (0.21)
1y postop BMD Gruen zone 4 minus baseline	-0.04 (0.05)	0.03 (0.10)
1y postop BMD Gruen zone 5 minus baseline	-0.02 (0.11)	0.03 (0.16)
1y postop BMD Gruen zone 6 minus baseline	-0.06 (0.14)	-0.06 (0.10)
1y postop BMD Gruen zone 7 minus baseline	-0.25 (0.12)	-0.14 (0.19)

2. Secondary Outcome

Title	Changes From Baseline in Patients' Function. Clinical Evaluation Using the Harris Hip Score
Description	The items in the Harris hip score (HHS) include an analysis of the operated hip according to pain, function, mobility and stability, and an analysis of deformities, in a scale form 0 point (the worst condition) to 100 points (the best condition). The Harris Hip Score will be used to assess the subjective and objective improvement in the patient. The usefulness of the score has been designed to estimate clinical outcomes after THA and demonstrated high reliability and validity. The HHS values at each time points, 6 weeks, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.
Time Frame	6 weeks, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HHS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).

Arm/Group Title	Quadra Group	AMIStem Group
Arm/Group Description	Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)	Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
Measure Participants	20	20
HHS 6 weeks difference vs preoperative	30.6 (17.8)	36.7 (17.3)
HHS 6 months difference vs preoperative	36.8 (17)	48.4 (13.6)
HHS 1y difference vs preoperative	41 (13.4)	51.3 (14.1)

3. Secondary Outcome

Title	Changes From Baseline in Patient's Activity Level. Assessment Using the High Activity Arthroplasty Score.
Description	The HAAS was designed to detect subtle variations in functional ability after lower limb arthroplasty, in a scale from 0 (minimum, the worst condition) to 18 points (maximum, the best condition) The HAAS values at each time points, 6 months and 1 year, and for each patient, will be reported as difference respect the preoperative value collected at preoperative.
Time Frame	6 months, 1 year

Outcome Measure Data

Analysis Population Description

20 patients/group were enrolled at beginning but from 6 weeks to 1 year time point the score was counted for patients available. At 6 weeks the HAAS was calculated for n=20 (AMIStem) and n=19 (Quadra), at 6 months n=20 (AMIStem) and n=18 (Quadra) and at 1 year n=18 (AMistem) and n=18 (Quadra).

Arm/Group Title	Quadra Group	AMIStem Group
Arm/Group Description	Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)	Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
Measure Participants	20	20
HAAS 6 months vs preoperative	2.6 (2.2)	3.1 (2.1)
HAAS 1y vs preoperative	3.8 (2.2)	4.1 (2.4)

4. Secondary Outcome

Title	Radiological Evaluation to Assess the Fixation and Stability of Femoral and Acetabular Components.
Description	Stability and fixation of both, femoral and acetabular component will be assessed counted number of events of stem subsidence, femoral and cup loosening, cup migration and presence of radiolucencies occurred during the study at 6 months and 1 year time points.
Time Frame	6 months, 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Quadra Group	AMIStem Group
Arm/Group Description	Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)	Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
Measure Participants	18	18
6M Stem radiolucencies presence bigger than 2mm	0 0%	0 0%
6M Stem subsidence	0 0%	0 0%
6M Femoral component loosening	0 0%	0 0%
6M Cup radiolucencies presence bigger than 2mm	0 0%	0 0%
6M Cup migration	0 0%	0 0%
6M Cup loosening	0 0%	0 0%
1y Stem radiolucencies presence bigger than 2mm	0 0%	0 0%
1y stem subsidence	0 0%	0 0%
1y femoral component loosening	0 0%	0 0%
1y cup radiolucencies presence bigger than 2mm	0 0%	0 0%
1y cup migration	0 0%	0 0%
1y cup loosening	0 0%	0 0%

Adverse Events

Arm/Group Title	Quadra Group		AMIStem Group
Arm/Group Description	Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)		Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
All Cause Mortality
	Quadra Group		AMIStem Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Quadra Group		AMIStem Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/20 (0%)
Surgical and medical procedures
Revision	1/20 (5%)	1	0/20 (0%)	0
Other (Not Including Serious) Adverse Events
	Quadra Group		AMIStem Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Both the investigator and Medacta have the right to publish or allow to be published the results of the trial. The investigator recognizes that Medacta has a special interest in the results of the trial and will submit manuscripts to Medacta prior to publication. If Medacta desires changes to be made, these are communicated to the investigator within 60 days.