Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT00463424
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-10
• Study Completion: 2005-08
• Status Verified: 2007-04
• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Last Update Submitted: 2007-04-19
• Study First Posted: 2007-04-20
• Last Update Posted: 2007-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximum active postoperative MP flexion

Secondary Outcome Measures

Name	Time	Method
Sollerman Hand Function Score
Jamar grip strength
Michigan Hand Questionnaire
Maximum active postoperative MP extension
Maximum active postoperative MP arc of motion
Ulnar drift

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada