A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement
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Purpose
The purpose of this study is to compare the performance of the Future hip, Omniflex hip, Zweymϋller hip and CLS Spotorno hip in the treatment of patients with hip joint disease requiring a total hip replacement. The first 100 subjects who enter the study will receive the Future hip. The next 300 patients who enter the study will be randomly allocated to the Future hip, Omniflex hip (Italy only), Zweymϋller hip (Austria only) or CLS Spotorno hip (Germany only). All patients will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments. A subset of patients will also undergo scans to allow the bone mineral density of the bone surrounding the implant to be monitored and special x-rays which allow the stability of the implant to be determined.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis Perthes Disease |
Device: Future Hip Device: Omniflex Device: Zueymüller Device: CLS Spotorno |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-centre, Randomised, Parallel Group, Controlled Study to Compare the Performance of the Future Hip Against Three Currently Used Implants in Total Hip Replacement |
- Implant survivorship at two years [ Time Frame: 2yrs post-surgery ] [ Designated as safety issue: Yes ]
- Implant survivorship at 5 and 10 years. [ Time Frame: 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: Yes ]
- Operative and post-operative complications [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 3yrs(RSA/DEXA patients only), 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: 3mths, 6mths, 1yr, 2yrs, 3yrs, 4yrs, 5yrs and 10 yrs post-surgery ] [ Designated as safety issue: No ]
- Radiological Assessment [ Time Frame: Immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs (RSA/DEXA patients only), 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
- RSA x-rays [ Time Frame: Immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
- DEXA analysis (at immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs, 5yrs and 10yrs post-surgery). [ Time Frame: Immediate post-op, 3mths, 6mths, 1yr, 2yrs, 3yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
| Enrollment: | 312 |
| Study Start Date: | February 2000 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1) Future Hip
A cementless femoral component for use in total hip replacement
|
Device: Future Hip
A cementless femoral component for use in total hip replacement
|
|
Active Comparator: 2) Omniflex
A cementless femoral component for use in total hip replacement
|
Device: Omniflex
A cementless femoral component for use in total hip replacement
|
|
Active Comparator: 3) Zueymüller
A cementless femoral component for use in total hip replacement
|
Device: Zueymüller
A cementless femoral component for use in total hip replacement
|
|
Active Comparator: 4) CLS Spotorno
A cementless femoral component for use in total hip replacement
|
Device: CLS Spotorno
A cementless femoral component for use in total hip replacement
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
i) Administrative - The subject is able to understand the study, is willing to give voluntary, written, informed consent, will co-operate with assessment procedures and is geographically able to comply with the post-operative follow-up regime.
ii) Age - The subject's age is between 18 and 75 years inclusive.
iii) Sex - Male or female subjects may be recruited to the study.
iv) Diagnosis -Subjects must be undergoing primary THR surgery for non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, post-traumatic arthritis, fractured neck of femur and non-union of fractured neck of femur, SUFE or Perthes disease.
v) Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study.
Exclusion Criteria:
i) Subjects undergoing revision procedure to the operative hip.
ii) Subjects who have had a previous femoral osteotomy to the operative hip.
iii) Subjects who have a history of active sepsis in the joint.
iv) Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).
v) Subjects with any condition which may, in the opinion of the Investigator, interfere with the total hip replacement's survival or outcome, e.g. Paget's disease, Charcot's disease.
vi) Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation.
vii) Subject's whose weight is > 100kg.
viii) Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only).
ix) Subjects who have a fracture of the femur > 6 months old (RSA and DEXA subjects only).
x) Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only)
xi) Subjects with a known history of poor compliance to medical treatment.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Roy Harvey, Clinical Research Manager, DePuy International Ltd |
| ClinicalTrials.gov Identifier: | NCT00208468 History of Changes |
| Other Study ID Numbers: | CT99/02 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 1, 2011 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
Keywords provided by DePuy International:
|
Hip Cementless |
Additional relevant MeSH terms:
|
Arthritis Collagen Diseases Femoral Fractures Fractures, Bone Hip Dislocation, Congenital Legg-Perthes Disease Necrosis Osteonecrosis Osteoarthritis Joint Diseases |
Musculoskeletal Diseases Connective Tissue Diseases Wounds and Injuries Leg Injuries Musculoskeletal Abnormalities Congenital Abnormalities Femur Head Necrosis Bone Diseases Pathologic Processes Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013