Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

Study Overview
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Brief Summary
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The main hypotheses for this study are as follows: 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. 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.

Detailed Description
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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.

Official Title
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NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Device: NeuFlex metacarpophalangeal implant
* Device: Swanson metacarpophalangeal implant


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NeuFlex metacarpophalangeal implant|nan|
|Device: Swanson metacarpophalangeal implant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum active postoperative MP flexion |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum active postoperative MP extension |  |  | 
| Maximum active postoperative MP arc of motion |  |  | 
| Ulnar drift |  |  | 
| Jamar grip strength |  |  | 
| Sollerman Hand Function Score |  |  | 
| Michigan Hand Questionnaire |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metacarpophalangeal Joint, Arthroplasty, Replacement, Range of Motion, Articular, Randomized Controlled Trials, Swanson, NeuFlex