Status:
TERMINATED
Multi-centre Study to Assess Long-term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary THR
Lead Sponsor:
DePuy International
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ev...
Detailed 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 repla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00878046
Start Date
May 1 2005
End Date
November 1 2014
Last Update
April 21 2016
Active Locations (7)
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1
Royal Newcastle Hospital
Broadmeadow, Australia
2
Prince of Wales Private Hospital
Sydney, Australia
3
Sydney Adventist Hospital
Sydney, Australia
4
Hôpital Raymond Poincaré
Garches, France