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Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00463424
Enrollment
40
Registered
2007-04-20
Start date
2000-10-31
Completion date
2005-08-31
Last updated
2007-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Metacarpophalangeal Joint, Arthroplasty, Replacement, Range of Motion, Articular, Randomized Controlled Trials, Swanson, NeuFlex

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.

Interventions

DEVICENeuFlex metacarpophalangeal implant
DEVICESwanson metacarpophalangeal implant

Sponsors

DePuy Orthopaedics
CollaboratorINDUSTRY
Stryker Trauma and Extremities
CollaboratorINDUSTRY
Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Maximum active postoperative MP flexion

Secondary

MeasureTime frame
Maximum active postoperative MP arc of motion
Ulnar drift
Maximum active postoperative MP extension
Sollerman Hand Function Score
Michigan Hand Questionnaire
Jamar grip strength

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026