Skip to main content
OpenTrials
Completed

NCT Number: NCT00463424

Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeuFlex metacarpophalangeal implant

Device

Swanson metacarpophalangeal implant

Device

Primary outcomes

  1. Maximum active postoperative MP flexion

Secondary outcomes

  1. Maximum active postoperative MP extension

  2. Maximum active postoperative MP arc of motion

  3. Ulnar drift

  4. Jamar grip strength

  5. Sollerman Hand Function Score

  6. Michigan Hand Questionnaire

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • DePuy Orthopaedics
  • Stryker Trauma and Extremities

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2005
First posted
Apr 20, 2007
Registry last updated
Apr 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.