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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00872573 |
The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used 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, standard x-ray assessments and special x-rays which allow the stability of the implant to be determined.
Condition | Intervention | Phase |
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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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 50 |
Study Start Date: | July 2006 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 60 Years to 80 Years |
Genders Eligible for Study: | Both |
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.
Responsible Party: | DePuy International Ltd ( Michael Borroff, B.Sc., M.Sc. Study Director ) |
Study ID Numbers: | CT03/14 |
Study First Received: | March 30, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00872573 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Hip Cemented |
Autoimmune Diseases Osteonecrosis Collagen Diseases Hip Dislocation Osteoarthritis Dislocations Joint Diseases Fractures, Bone Wounds and Injuries Arthritis, Rheumatoid Disorders of Environmental Origin Rheumatic Diseases |
Bone Diseases Musculoskeletal Abnormalities Femoral Fractures Necrosis Musculoskeletal Diseases Epiphyses, Slipped Arthritis Connective Tissue Diseases Hip Dysplasia Leg Injuries Congenital Abnormalities Hip Dislocation, Congenital |
Autoimmune Diseases Immune System Diseases Collagen Diseases Osteonecrosis Osteoarthritis Joint Diseases Fractures, Bone Wounds and Injuries Arthritis, Rheumatoid Disorders of Environmental Origin Rheumatic Diseases Bone Diseases |
Musculoskeletal Abnormalities Femoral Fractures Necrosis Pathologic Processes Musculoskeletal Diseases Epiphyses, Slipped Arthritis Connective Tissue Diseases Leg Injuries Congenital Abnormalities Hip Dislocation, Congenital |