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Sponsors and Collaborators: |
St. Michael's Hospital, Toronto DePuy Orthopaedics Wright Medical Technology |
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Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00463424 |
The main hypotheses for this study are as follows:
Condition | Intervention | Phase |
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Arthritis, Rheumatoid |
Device: NeuFlex metacarpophalangeal implant Device: Swanson metacarpophalangeal implant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial |
Estimated Enrollment: | 40 |
Study Start Date: | October 2000 |
Study Completion Date: | August 2005 |
Many studies have evaluated metacarpophalangeal joint (MP) range of motion following Swanson arthroplasty. These studies report that overall MP flexion is restricted postoperatively. They do not usually report individual range of motion values for each digit. Therefore one cannot identify if the degree of MP flexion restriction differs by digit.
We, and others, have observed that MP flexion is particularly restricted in the ring and litter finger following Swanson arthroplasty.
There is a new implant (NeuFlex), which instead of being introduced in full extension, like the Swanson implant, has a resting position of 30 degrees of flexion. As MP flexion is particularly restricted in the ring and little finger, an implant that by design encourages flexion may be helpful. A need exists to establish if the use of the NeuFlex implant produces greater MP flexion in the ring and little finger where restricted flexion has been identified as a problem.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 |
Principal Investigator: | Earl R Bogoch, MD | St. Michael's Hospital, University of Toronto |
Study ID Numbers: | REB#2K-049C |
Study First Received: | April 19, 2007 |
Last Updated: | April 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00463424 |
Health Authority: | Canada: Dr. Arthur Slutsky, VP Research, St. Michael's Hospital |
Metacarpophalangeal Joint Arthroplasty, Replacement Range of Motion, Articular |
Randomized Controlled Trials Swanson NeuFlex |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Immune System Diseases |