A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement
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Purpose
| 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: C-Stem™ AMT Femoral Component (standard and high off-set variants) | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Prospective, Uncontrolled, Two-centre, RSA, Post-market Surveillance Study to Evaluate the Stability of the C-Stem™ AMT Femoral Component in Primary Total Hip Arthroplasty. |
- Distal migration of the femoral stem at the 5-year time point [ Time Frame: 5 years ]
- ML/AP translation and all rotations out to 5 years [ Time Frame: pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery ]
- Harris Hip score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ]
- Oxford Hip score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ]
- Radiological analysis [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ]
| Enrollment: | 5 |
| Actual Study Start Date: | July 1, 2006 |
| Study Completion Date: | October 1, 2007 |
| Primary Completion Date: | October 1, 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| C-Stem™ AMT Femoral Component |
Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)
A polished triple tapered cemented femoral component for use in total hip replacement
|
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 60 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
i) Male or female subjects, aged between 60 and 80 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 that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.
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 replacements.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872573
| United Kingdom | |
| North Bristol NHS Trust | |
| Bristol, United Kingdom | |
More Information
| Responsible Party: | DePuy International |
| ClinicalTrials.gov Identifier: | NCT00872573 History of Changes |
| Other Study ID Numbers: |
CT03/14 |
| First Submitted: | March 30, 2009 |
| First Posted: | March 31, 2009 |
| Last Update Posted: | June 26, 2017 |
| Last Verified: | June 2017 |
Keywords provided by DePuy International:
|
Hip Cemented |
Additional relevant MeSH terms:
|
Arthritis Osteoarthritis Arthritis, Rheumatoid Fractures, Bone Necrosis Femoral Fractures Hip Dislocation Hip Dislocation, Congenital Slipped Capital Femoral Epiphyses Collagen Diseases Rheumatic Diseases Joint Diseases Musculoskeletal Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Wounds and Injuries Pathologic Processes Leg Injuries Joint Dislocations Bone Diseases Hip Injuries Musculoskeletal Abnormalities Congenital Abnormalities Osteochondrodysplasias Bone Diseases, Developmental Epiphyses, Slipped |