A Multi-centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Polyethylene-on-metal Bearing in Primary Total Hip Replacement
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Purpose
The purpose of this study is to monitor the performance of the Pinnacle™ Cup with a polyethylene-on-metal bearing combination 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Osteoarthritis Post-traumatic Arthritis Collagen Disorders Avascular Necrosis Traumatic Femoral Fractures Nonunion of Femoral Fractures Congenital Hip Dysplasia Slipped Capital Femoral Epiphysis. |
Device: Pinnacle Acetabular System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement |
- Kaplan-Meier survivorship calculated at the five-year time-point. [ Time Frame: 5 yrs post surgery ] [ Designated as safety issue: Yes ]
- Harris Hip Score [ Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Kaplan-Meier survivorship [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
i) Male or female subjects, aged between 18 and 70 years inclusive.
ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
iii) 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.
iv) Subjects undergoing primary total hip replacement who are suitable for a cementless acetabular component and a metal on polyethylene bearing.
Exclusion Criteria:
i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
ii) Subjects undergoing revision hip replacement.
iii) Subjects undergoing simultaneous bilateral hip operation.
iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
v) Women who are pregnant.
vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
viii) Subjects who are currently involved in any injury litigation claims.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | DePuy International |
| ClinicalTrials.gov Identifier: | NCT00208429 History of Changes |
| Other Study ID Numbers: | CT03/40 |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by DePuy International:
|
Hip Cementless |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Collagen Diseases Femoral Fractures Fractures, Bone Hip Dislocation, Congenital Necrosis Osteonecrosis Osteoarthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Wounds and Injuries Leg Injuries Musculoskeletal Abnormalities Congenital Abnormalities Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on May 16, 2013