A Single Centre Study to Assess the Long-term Performance of the Pinnacle™ Cup With a Ceramic-on-ceramic 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 ceramic-on-ceramic 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 Prosthesis With a Ceramic-on-ceramic Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement |
- Kaplan-Meier survivorship at the five-year period [ Time Frame: 5yrs ] [ Designated as safety issue: Yes ]
- Kaplan-Meier survivorship calculations [ Time Frame: Annually ] [ 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 ]
- Radiographic analysis [ Time Frame: 6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
- Oxford Hip score [ Time Frame: 3yrs, 4yrs, 6yrs, 8yrs, 9yrs, 11yrs, 12yrs, 13yrs and 14yrs post-surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2006 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
-
Device: Pinnacle™ Acetabular System
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 cementless acetabular components.
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) Women who are pregnant.
iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
vi) Subjects who are currently involved in any injury litigation claims.
vii) Subjects undergoing a simultaneous bilateral hip operation.
viii) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
ix) Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Roy Harvey, Clinical Research Manger, DePuy International Ltd |
| ClinicalTrials.gov Identifier: | NCT00872222 History of Changes |
| Other Study ID Numbers: | CT03/39 |
| Study First Received: | March 30, 2009 |
| Last Updated: | September 1, 2011 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Keywords provided by DePuy International:
|
Hip Cementless Ceramic-on-Ceramic |
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 19, 2013