Osteoarthritis
Conditions
Keywords
Hip, Cementless, Conservative
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
Interventions
A short cementless, femoral component for use in total hip arthroplasty
Sponsors
Johnson & Johnson
DePuy International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complications | 6mths post-surgery |
| Harris Hip score change at 6mths post-surgery | 6mths post-surgery |
Secondary
| Measure | Time frame |
|---|---|
| UCLA Activity Rating | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery |
| Incidence of post operative radiological signs | 7 days, 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery |
| Harris Hip Score | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery |
| Kaplan-Meier Survivorship Calculations | 3 months, 6 months, and Annually |
| Change in bone mineral density | 7days, 3mths, 6mths, 1yr and 2yrs post-surgery |
| Oxford Hip Score | 3mths, 6mths, 1yr, 2yrs, 5yrs, 10yrs and 15yrs post-surgery |
Countries
Australia, France, Germany, Italy, United Kingdom
Outcome results
None listed