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Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

NCT ID: NCT00463424

Last Updated: 2007-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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NeuFlex metacarpophalangeal implant

Intervention Type DEVICE

Swanson metacarpophalangeal implant

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Orthopaedics

INDUSTRY

Sponsor Role collaborator

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Earl R Bogoch, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, University of Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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. doi: 10.1016/j.jhsb.2004.10.013.

Reference Type BACKGROUND
PMID: 15620484 (View on PubMed)

Erdogan A, Weiss AP. [NeuFlex Silastic implant in metacarpophalangeal joint arthroplasty]. Orthopade. 2003 Sep;32(9):789-93. doi: 10.1007/s00132-003-0524-0. German.

Reference Type BACKGROUND
PMID: 14508644 (View on PubMed)

Joyce TI, Unsworth A. NeuFlex metacarpophalangeal prostheses tested in vitro. Proc Inst Mech Eng H. 2005;219(2):105-10. doi: 10.1243/095441105X9192.

Reference Type BACKGROUND
PMID: 15819481 (View on PubMed)

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. doi: 10.1016/j.jhsa.2004.04.023.

Reference Type BACKGROUND
PMID: 15465227 (View on PubMed)

Other Identifiers

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REB#2K-049C

Identifier Type: -

Identifier Source: org_study_id