An Electronic Data Capture Study to Assess the Long-term Performance of the DePuy PROXIMA™ Hip in Primary Total Hip Replacement

Sponsor

DePuy International (Industry)

Overall Status

Terminated

CT.gov ID

NCT01134445

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

10.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to monitor the performance of the DePuy PROXIMA™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Avascular Necrosis Traumatic Femoral Fractures Congenital Hip Dysplasia	Device: DePuy Proxima™ Hip	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy PROXIMA™ Hip in Subjects With Indications Suitable for a Primary Total Hip Arthroplasty

Actual Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: DePuy Proxima™ Hip A short, anatomic, cementless femoral component for use in total hip arthroplasty	Device: DePuy Proxima™ Hip A short, anatomic, cementless femoral component for use in total hip arthroplasty

Arm

Intervention/Treatment

Other: DePuy Proxima™ Hip

A short, anatomic, cementless femoral component for use in total hip arthroplasty

Device: DePuy Proxima™ Hip

A short, anatomic, cementless femoral component for use in total hip arthroplasty

Outcome Measures

Primary Outcome Measures

Kaplan-Meier survivorship calculated at the five-year time-point [5yrs post surgery]

Secondary Outcome Measures

Annual Kaplan-Meier survivorship calculations [1yr post-surgery]
Harris Hip Score [6mths post-surgery]
Oxford Hip Score [3mths post-surgery]
UCLA Activity Score [3mths post-surgery]
Hip Outcome Score [3mths post-surgery]
EuroQol EQ-5D [3mths post-surgery]
Annual Kaplan-Meier survivorship calculations [2yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [3yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [4yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [6yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [7yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [8yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [9yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [10yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [11yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [12yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [13yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [14yrs post-surgery]
Annual Kaplan-Meier survivorship calculations [15yrs post-surgery]
Harris Hip Score [1yr post-surgery]
Harris Hip Score [2yrs post-surgery]
Harris Hip Score [5yrs post-surgery]
Harris Hip Score [10yrs post-surgery]
Harris Hip Score [15yrs post-surgery]
Radiographic Analysis [3mths post-surgery]
Radiographic Analysis [6mths post-surgery]
Radiographic Analysis [1yr post-surgery]
Radiographic Analysis [2yrs post-surgery]
Radiographic Analysis [5yrs post-surgery]
Radiographic Analysis [10yrs post-surgery]
Radiographic Analysis [15 yrs post-surgery]
Oxford Hip Score [6mths post-surgery]
Oxford Hip Score [1yr post-sugery]
UCLA Activity Score [6mths post-surgery]
UCLA Activity Score [1yr post-surgery]
Hip Outcome Score [6mths post-surgery]
Hip Outcome Score [1yr post-surgery]
EuroQol EQ-5D [6mths post-surgery]
EuroQol EQ-5D [1yr post-surgery]
Oxford Hip Score [2yrs post-surgery]
Oxford Hip Score [3yrs post-surgery]
Oxford Hip Score [4yrs post-surgery]
Oxford Hip Score [5yrs post-surgery]
Oxford Hip Score [6yrs post-surgery]
Oxford Hip Score [7yrs post-surgery]
Oxford Hip Score [8yrs post-surgery]
Oxford Hip Score [9yrs post surgery]
Oxford Hip Score [10yrs post-surgery]
Oxford Hip Score [11yrs post-surgery]
Oxford Hip Score [12yrs post-surgery]
Oxford Hip Score [13yrs post-sugery]
Oxford Hip Score [14yrs post-surgery]
Oxford Hip Score [15yrs post-surgery]
UCLA Activity Score [2yrs post-surgery]
UCLA Activity Score [3yrs post-surgery]
UCLA Activity Score [4yrs post-surgery]
UCLA Activity Score [5yrs post-surgery]
UCLA Activity Score [6yrs post-surgery]
UCLA Activity Score [7yrs post-surgery]
UCLA Activity Score [8yrs post-surgery]
UCLA Activity Score [9yrs post-surgery]
UCLA Activity Score [10yrs post-surgery]
UCLA Activity Score [11yrs post-surgery]
UCLA Activity Score [12yrs post-surgery]
UCLA Activity Score [13yrs post-surgery]
UCLA Activity Score [14yrs post-surgery]
UCLA Activity Score [15yrs post-surgery]
Hip Outcome Score [2yrs post-surgery]
Hip Outcome Score [3yrs post-surgery]
Hip Outcome Score [4yrs post-surgery]
Hip Outcome Score [5yrs post-surgery]
Hip Outcome Score [6yrs post-surgery]
Hip Outcome Score [7yrs post-surgery]
Hip Outcome Score [8yrs post-surgery]
Hip Outcome Score [9yrs post-surgery]
Hip Outcome Score [10yrs post-surgery]
Hip Outcome Score [11yrs post-surgery]
Hip Outcome Score [12yrs post-surgery]
Hip Outcome Score [13yrs post-surgery]
Hip Outcome Score [14yrs post-surgery]
Hip Outcome Score [15yrs post-surgery]
EuroQol EQ-5D [2yrs post-surgery]
EuroQol EQ-5D [3yrs post-surgery]
EuroQol EQ-5D [4yrs post-surgery]
EuroQol EQ-5D [5yrs post-surgery]
EuroQol EQ-5D [6yrs post-surgery]
EuroQol EQ-5D [7yrs post-surgery]
EuroQol EQ-5D [8yrs post-surgery]
EuroQol EQ-5D [9yrs post-surgery]
EuroQol EQ-5D [10yrs post-surgery]
EuroQol EQ-5D [11yrs post-surgery]
EuroQol EQ-5D [12yrs post-surgery]
EuroQol EQ-5D [13yrs post-surgery]
EuroQol EQ-5D [14yrs post-surgery]
EuroQol EQ-5D [15yrs post-surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects between 18 and 70 years of age.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups.
Subjects who are scheduled to undergo a primary THR whom the surgeon considers to be suitable for the DePuy PROXIMATM hip femoral prosthesis.

Exclusion Criteria:

Subjects with active local or systemic infection
Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
Subjects with Charcot's or Paget's disease.
Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur.
Subjects with severe osteoporosis.
Subjects with previous proximal femoral fractures.
Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
Subjects who are currently involved in any injury litigation claims.
Subjects for whom the surgical procedure is a revision of a previous THR, hemi-arthroplasty or hip resurfacing
Subjects who have previously undergone osteotomy or arthrodesis of the hip.
Subjects undergoing a simultaneous bilateral hip operation.
Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily