Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00463424
Status:
COMPLETED
Last Update Posted:
2007-04-20
First Post:
2007-04-19
Brief Title:
Comparison of NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
NeuFlex and Swanson Metacarpophalangeal Implants for Rheumatoid Arthritis a Prospective Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 kg or more greater grip strength than with the use of the Swanson implant
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 25 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None