Ignite Creation Date:
2024-05-06 @ 12:17 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03722303
Status:
SUSPENDED
Last Update Posted:
2018-10-29
First Post:
2018-10-25
Brief Title:
Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Lipografting Versus Steroid Injections for Treatment of Primary Mild to Moderate Carpal Tunnel Syndrome
Status:
SUSPENDED
Status Verified Date:
2024-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care corticosteroid treatment The investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration better than the standard of care treatment
Detailed Description:
Carpal tunnel syndrome CTS is the most common entrapment neuropathy affecting up to 13 of Americans CTS is caused by compression of the median nerve in the carpal tunnel leading to nerve ischemia and symptoms of numbness pain and tingling Treatment options depend on the severity of symptoms and range from noninvasive options most commonly steroid injections to definitive surgical release of the compressed median nerve Both non-invasive techniques and surgical intervention have their shortcomings thus a novel approach for CTS treatment may be indicated
Lipografting is an established validated and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities From observing these reconstructions plastic surgeons have witnessed the regenerative properties of fat transfer specifically delaying the affects of chronic radio-dermatitis These clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation bringing neo-angiogenesis and providing a barrier against scar adhesions This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care corticosteroid treatment Ideally the fat transfer would prevent scar formation and aid in nerve excursion along the canal while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration
Lipografting is an established validated and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities From observing these reconstructions plastic surgeons have witnessed the regenerative properties of fat transfer specifically delaying the affects of chronic radio-dermatitis These clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation bringing neo-angiogenesis and providing a barrier against scar adhesions This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care corticosteroid treatment Ideally the fat transfer would prevent scar formation and aid in nerve excursion along the canal while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None