Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis
NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2000
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedApril 20, 2007
April 1, 2007
April 19, 2007
April 19, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum active postoperative MP flexion
Secondary Outcomes (6)
Maximum active postoperative MP extension
Maximum active postoperative MP arc of motion
Ulnar drift
Jamar grip strength
Sollerman Hand Function Score
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- rheumatoid arthritis
- primary metacarpophalangeal arthroplasty of all 4 digits
You may not qualify if:
- diagnosis of other connective tissue disorder (e.g. SLE, MCTD)
- previous surgery of MP joints
- revision metacarpophalangeal arthroplasty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- DePuy Orthopaedicscollaborator
- Stryker Trauma and Extremitiescollaborator
Study Sites (1)
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Related Publications (4)
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. doi: 10.1016/j.jhsb.2004.10.013.
PMID: 15620484BACKGROUNDErdogan A, Weiss AP. [NeuFlex Silastic implant in metacarpophalangeal joint arthroplasty]. Orthopade. 2003 Sep;32(9):789-93. doi: 10.1007/s00132-003-0524-0. German.
PMID: 14508644BACKGROUNDJoyce TI, Unsworth A. NeuFlex metacarpophalangeal prostheses tested in vitro. Proc Inst Mech Eng H. 2005;219(2):105-10. doi: 10.1243/095441105X9192.
PMID: 15819481BACKGROUNDWeiss 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. doi: 10.1016/j.jhsa.2004.04.023.
PMID: 15465227BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Earl R Bogoch, MD
St. Michael's Hospital, University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 19, 2007
First Posted
April 20, 2007
Study Start
October 1, 2000
Study Completion
August 1, 2005
Last Updated
April 20, 2007
Record last verified: 2007-04