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Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborators:
DePuy Orthopaedics
Wright Medical Technology
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00463424
First received: April 19, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.

Condition Intervention Phase
Arthritis, Rheumatoid
 Device: NeuFlex metacarpophalangeal implant
Device: Swanson metacarpophalangeal implant
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Maximum active postoperative MP flexion

Secondary Outcome Measures:
  • Maximum active postoperative MP extension
  • Maximum active postoperative MP arc of motion
  • Ulnar drift
  • Jamar grip strength
  • Sollerman Hand Function Score
  • Michigan Hand Questionnaire

Estimated Enrollment: 40
Study Start Date: October 2000
Study Completion Date: August 2005
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463424

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
DePuy Orthopaedics
Wright Medical Technology
Investigators
Principal Investigator: Earl R Bogoch, MD St. Michael's Hospital, University of Toronto
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00463424     History of Changes
Other Study ID Numbers: REB#2K-049C
Study First Received: April 19, 2007
Last Updated: April 19, 2007
Health Authority: Canada: Dr. Arthur Slutsky, VP Research, St. Michael's Hospital

Keywords provided by St. Michael's Hospital, Toronto:
Metacarpophalangeal Joint
Arthroplasty, Replacement
Range of Motion, Articular
 Randomized Controlled Trials
Swanson
NeuFlex

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013