Multi-centre Study to Assess Long-term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary THR

DePuy Synthes

Status

Terminated

Conditions

Osteoarthritis

Treatments

Device: DePuy Silent™ Hip femoral prosthesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT00878046

CT05/01

Details and patient eligibility

About

The purpose of this study is to determine if the Silent™ hip is effective 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. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

Full description

The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is effective 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. A subset of patients will undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects, aged 18 years or above at the point of screening for participation.
Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-treatment follow-ups.
Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement and are considered suitable for a cementless femoral and acetabular component.

Exclusion criteria

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their 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 months. This exclusion does not apply to those subjects who are participating in the pilot investigation of the DePuy Silent Hip (CT01/27)
Subjects who are currently involved in any injury litigation claims.
Subjects who have osteonecrosis of the femoral neck
Subjects with significant bone loss or gross deformity in the region of the neck of the femur as identified on the pre-operative radiographs, where in the Investigator's opinion, there could be considerable migration of the DePuy Silent Hip or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the DePuy Silent Hip.
Subjects with a Charnley C classification.
Subjects with an active local or systemic infection.
Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the arthroplasty procedure unjustified.
Subjects with Paget's disease