Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463424
• Other study ID #: REB#2K-049C
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2007
• Last updated: April 19, 2007
• Start date: October 2000
• Est. completion date: August 2005

Study information

• Verified date: April 2007
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Dr. Arthur Slutsky, VP Research, St. Michael's Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Device:
• NeuFlex metacarpophalangeal implant

• Swanson metacarpophalangeal implant

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	DePuy Orthopaedics, Wright Medical Technology

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View Citation

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum active postoperative MP flexion
Secondary	Maximum active postoperative MP extension
Secondary	Maximum active postoperative MP arc of motion
Secondary	Ulnar drift
Secondary	Jamar grip strength
Secondary	Sollerman Hand Function Score
Secondary	Michigan Hand Questionnaire