Clinical trial NCT00463424: Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis
Official title: NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis: a Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Metacarpophalangeal Joint
Arthroplasty, Replacement
Range of Motion, Articular
Randomized Controlled Trials
Swanson
NeuFlex
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
name: Stryker Trauma and Extremities
First posted: 2007-04-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Maximum active postoperative MP flexion
Secondary outcomes:
measure: Maximum active postoperative MP extension
measure: Maximum active postoperative MP arc of motion
measure: Ulnar drift
measure: Jamar grip strength
measure: Sollerman Hand Function Score
measure: Michigan Hand Questionnaire
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, University of Toronto
name: Earl R Bogoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Joyce TI, Unsworth A. NeuFlex metacarpophalangeal prostheses tested in vitro. Proc Inst Mech Eng H. 2005;219(2):105-10. doi: 10.1243/095441105X9192.
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. doi: 10.1016/j.jhsa.2004.04.023.