Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 injury)has 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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3
Healthy Volunteers: f
View:

• Idiopathic clubfoot.

• Age less than or equal to 36 months at the time of tenotomy.

• Enrolled at the Pehla Qadam clinic at The Indus Hospital in Karachi.

• Fully corrected Adductus deformity with residual equinus after a full casting cycle.

• Completing routine follow up for 3 months post tenotomy.

Locations
Other Locations
Pakistan
Indus Hospital
Karachi
Time Frame
Start Date: 2020-03-27
Completion Date: 2023-12-16
Participants
Target number of participants: 244
Treatments
Experimental: Needle tenotomy
Patient will receive an Achilles tendon tenotomy using a 22G needle when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.
Active_comparator: Blade tenotomy
Patient will receive an Achilles tendon tenotomy using a 11 blade when randomized into the needle group. Follow-up to measure dorsiflexion and register complications will be assured at 3 weeks and 3 months.
Related Therapeutic Areas
Sponsors
Leads: Indus Hospital and Health Network

This content was sourced from clinicaltrials.gov