Arthritis, Rheumatoid Clinical Trial
Official title:
NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial
The main hypotheses for this study are as follows:
1. The use of NeuFlex implant results in flexion in the fourth and fifth MP joints that is
at least 10 degrees greater than with teh use of the Swanson implant.
2. The use of the NeuFlex implant is associated with a significantly (2.5 kg or more)
greater grip strength than with the use of the Swanson implant.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - rheumatoid arthritis - primary metacarpophalangeal arthroplasty of all 4 digits Exclusion Criteria: - diagnosis of other connective tissue disorder (e.g. SLE, MCTD) - previous surgery of MP joints - revision metacarpophalangeal arthroplasty |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | DePuy Orthopaedics, Wright Medical Technology |
Canada,
Delaney R, Trail IA, Nuttall D. A comparative study of outcome between the Neuflex and Swanson metacarpophalangeal joint replacements. J Hand Surg Br. 2005 Feb;30(1):3-7. — View Citation
Erdogan A, Weiss AP. [NeuFlex Silastic implant in metacarpophalangeal joint arthroplasty]. Orthopade. 2003 Sep;32(9):789-93. German. — View Citation
Joyce TI, Unsworth A. NeuFlex metacarpophalangeal prostheses tested in vitro. Proc Inst Mech Eng H. 2005;219(2):105-10. — View Citation
Weiss AP, Moore DC, Infantolino C, Crisco JJ, Akelman E, McGovern RD. Metacarpophalangeal joint mechanics after 3 different silicone arthroplasties. J Hand Surg Am. 2004 Sep;29(5):796-803. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum active postoperative MP flexion | |||
Secondary | Maximum active postoperative MP extension | |||
Secondary | Maximum active postoperative MP arc of motion | |||
Secondary | Ulnar drift | |||
Secondary | Jamar grip strength | |||
Secondary | Sollerman Hand Function Score | |||
Secondary | Michigan Hand Questionnaire |
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