Comparison of NeuFlex and Swanson Metacarpophalangeal Imp... | NCT00463424

Studies
Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis

NCT00463424

Sponsor

Unity Health Toronto

Status

Completed

Last Update Posted

Apr 20, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Arthritis, Rheumatoid

Interventions

NeuFlex metacarpophalangeal implant
Swanson metacarpophalangeal implant

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2000

Primary Completion Date

Not provided

Completion Date

Aug 2005Actual

First Submitted Date

Apr 19, 2007

First Submission Date that Met QC Criteria

Apr 19, 2007

First Posted Date

Apr 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2007

Last Update Posted Date

Apr 20, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Unity Health TorontoOTHER

Collaborators

Name	Class
DePuy Orthopaedics	INDUSTRY
Stryker Trauma and Extremities	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum active postoperative MP flexion

Secondary Outcomes

Measure	Description	Time Frame
Maximum active postoperative MP extension
Maximum active postoperative MP arc of motion
Ulnar drift

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Earl R Bogoch, MD	St. Michael's Hospital, University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Michael's Hospital		Toronto	Ontario	M5B 1W8	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15620484	Background	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.
14508644	Background	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.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Name	Type	Description	Arm Group Labels	Other Names
NeuFlex metacarpophalangeal implant	Device
Swanson metacarpophalangeal implant	Device