Clinical trial NCT00878046: Multi-centre Study to Assess Long-term Safety and Efficacy of the Silent™ Hip Prosthesis in Primary THR
Official title: A Non-comparative, Multi-centre Study to Evaluate the Safety and Efficacy of the DePuy Silent™ Hip Prosthesis in Primary Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Keywords: Hip
Cementless
Conservative
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson
First posted: 2009-04-08
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of complications
timeFrame: 6mths post-surgery
measure: Harris Hip score change at 6mths post-surgery
timeFrame: 6mths post-surgery
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
measure: Oxford Hip Score
timeFrame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
measure: UCLA Activity Rating
timeFrame: 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
measure: Incidence of post operative radiological signs
timeFrame: 7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery
measure: Change in bone mineral density
timeFrame: 7days, 3mths, 6mths, 1yr and 2yrs post-surgery
measure: Kaplan-Meier Survivorship Calculations
timeFrame: 3 months, 6 months, and Annually
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Royal Newcastle Hospital
city: Sydney
country: Australia
facility: Prince of Wales Private Hospital
city: Sydney
country: Australia
facility: Sydney Adventist Hospital
city: Garches
country: France
facility: Hôpital Raymond Poincaré
city: Frankfurt
country: Germany
facility: Orthopädishe Universitätsklinik
city: Jesi
country: Italy
facility: Ospedali Riuniti di Jesi
city: Cardiff
country: United Kingdom
facility: Llandough Hospital
Study officials:
References: