Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis - Full Text View

Sponsors and Collaborators:	St. Michael's Hospital, Toronto DePuy Orthopaedics Wright Medical Technology
Information provided by:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT00463424

Purpose

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.

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

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial

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:

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.

Erdogan A, Weiss AP. [NeuFlex Silastic implant in metacarpophalangeal joint arthroplasty] Orthopade. 2003 Sep;32(9):789-93. German.

Joyce TI, Unsworth A. NeuFlex metacarpophalangeal prostheses tested in vitro. Proc Inst Mech Eng [H]. 2005;219(2):105-10.

Weiss 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.

Study ID Numbers:	REB#2K-049C
Study First Received:	April 19, 2007
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00463424
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

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009