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

Phase 4

Terminated

• Conditions: Avascular Necrosis; Traumatic Femoral Fractures; Osteoarthritis; Congenital Hip Dysplasia; Rheumatoid Arthritis; Post-traumatic Arthritis

• Registration Number: NCT01134445
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2016-01-01
• Study Completion: 2016-06-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-23
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship calculated at the five-year time-point	5yrs post surgery

Secondary Outcome Measures

Name	Time	Method
Annual Kaplan-Meier survivorship calculations	15yrs post-surgery
Harris Hip Score	15yrs post-surgery
Oxford Hip Score	15yrs post-surgery
UCLA Activity Score	15yrs post-surgery
Hip Outcome Score	15yrs post-surgery
EuroQol EQ-5D	15yrs post-surgery
Radiographic Analysis	15 yrs post-surgery

Trial Locations

Locations (4)

Hospital Belle Isle; 🇫🇷 Metz, France

Hospital de Santo Antonio; 🇵🇹 Porto, Portugal

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Pilgrim Hospital; 🇬🇧 Boston, United Kingdom