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Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
NeuFlex metacarpophalangeal implant
Swanson metacarpophalangeal implant
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Metacarpophalangeal Joint, Arthroplasty, Replacement, Range of Motion, Articular, Randomized Controlled Trials, Swanson, NeuFlex

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's Hospital

Outcomes

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

Full Information

First Posted
April 19, 2007
Last Updated
April 19, 2007
Sponsor
Unity Health Toronto
Collaborators
DePuy Orthopaedics, Stryker Trauma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00463424
Brief Title
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

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Unity Health Toronto
Collaborators
DePuy Orthopaedics, Stryker Trauma GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Metacarpophalangeal Joint, Arthroplasty, Replacement, Range of Motion, Articular, Randomized Controlled Trials, Swanson, NeuFlex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
NeuFlex metacarpophalangeal implant
Intervention Type
Device
Intervention Name(s)
Swanson metacarpophalangeal implant
Primary Outcome Measure Information:
Title
Maximum active postoperative MP flexion
Secondary Outcome Measure Information:
Title
Maximum active postoperative MP extension
Title
Maximum active postoperative MP arc of motion
Title
Ulnar drift
Title
Jamar grip strength
Title
Sollerman Hand Function Score
Title
Michigan Hand Questionnaire

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Earl R Bogoch, MD
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15620484
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.
Results Reference
background
PubMed Identifier
14508644
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.
Results Reference
background
PubMed Identifier
15819481
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.
Results Reference
background
PubMed Identifier
15465227
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.
Results Reference
background

Learn more about this trial

Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

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