Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897100
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2021-05-18
Brief Title:
Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot
Sponsor:
Indus Hospital and Health Network
Organization:
Indus Hospital and Health Network
Study Overview
Official Title:
Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Achilles tendon tenotomy is an integral part of the Ponseti method aimed at correcting residual equinus after correction of the adductus deformity Tenotomy rates ranging from 63-95 after full cycle of castings have been reported in literature Percutaneous tenotomy is the gold standard which can usually be performed in an out-patient setting under local anesthesia using a scalpel blade A complication rate of 2 mainly neurovascular injuryhas been reported in literature with accidental sectioning of the peroneal artery being the most common Development of a pseudo-aneurysm after accidental sectioning of the peroneal artery has been reported in a case report this delayed further clubfoot treatment
Percutaneous needle tenotomy has been described by some authors as an alternative technique with very favorable results in a population before walking age This technique use a large-gauge 16-19 G needle to percutaneously cut the Achilles tendon Although bleeding has been reported following this technique with similar rates as for the percutaneous blade technique no major complications have been reported as yet using the needle technique
We would like to compare the clinical outcomes and complication rates of both techniques supporting our hypothesis that both techniques are equally safe and have the same success rate
Percutaneous needle tenotomy has been described by some authors as an alternative technique with very favorable results in a population before walking age This technique use a large-gauge 16-19 G needle to percutaneously cut the Achilles tendon Although bleeding has been reported following this technique with similar rates as for the percutaneous blade technique no major complications have been reported as yet using the needle technique
We would like to compare the clinical outcomes and complication rates of both techniques supporting our hypothesis that both techniques are equally safe and have the same success rate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None