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

DePuy Synthes

Status and phase

Terminated

Phase 4

Conditions

Osteoarthritis

Congenital Hip Dysplasia

Avascular Necrosis

Post-traumatic Arthritis

Traumatic Femoral Fractures

Rheumatoid Arthritis

Treatments

Device: DePuy Proxima™ Hip

Study type

Interventional

Funder types

Industry

Identifiers

NCT01134445

CT07/02

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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