Status:
COMPLETED
Study to Assess the Stability, Efficacy and Safety of the Silent™ Hip Prosthesis in Primary Total Hip Replacement
Lead Sponsor:
DePuy International
Collaborating Sponsors:
Johnson and Johnson Medical
Conditions:
Osteoarthritis
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if the Silent™ hip, when used as part of an artificial hip joint, is stable and effective in treatment of patients with joint disease requiring a total hip re...
Detailed Description
The Primary Objective of this study was to evaluate the short-term stability of the Silent Hip, implanted using a manual or navigated technique, using radiostereometric analysis (RSA). The study was a...
Eligibility Criteria
Inclusion
- Male or female subjects, aged between 25 and 65 years inclusive.
- 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 are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects with non-inflammatory osteoarthritis of the hip who require a primary total hip replacement.
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 month(s).
- Subjects who are currently involved in any injury litigation claims.
- Subjects who have osteonecrosis of the femoral neck
- Subjects who have an existing contralateral hip, ankle or knee replacement or an ipsilateral knee or ankle replacement or any metal implant in the lower lumber spine (navigated cases only).
- Subjects who are greater than 90kg in weight.
- Subject who have a CCD angle of the anatomical femur less than 125˚
- 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 prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the prosthesis.
- 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
- Subjects who still plan in the future to have children.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00894140
Start Date
January 1 2003
End Date
May 1 2014
Last Update
September 26 2016
Active Locations (2)
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1
Sydney Adventist Hospital
Sydney, Australia
2
General Hospital Eilbek
Hamburg, Germany