Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot
Primary Purpose
Club Foot, Achilles Tendon Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Achilles tendon tenotomy
Sponsored by
About this trial
This is an interventional treatment trial for Club Foot
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Refusal of parents to enroll child into this study.
- Syndromic clubfoot.
- Previous treatment for clubfoot (surgical or non-surgical) received.
- Underlying medical conditions unrelated to clubfoot that may serve as a contra-indication, this decision will be left on the discretion of the treating orthopedic surgeon
Sites / Locations
- Indus HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Needle tenotomy
Blade tenotomy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Dorsiflexion
Ankle dorsiflexion measured in degrees
Secondary Outcome Measures
Complications
Post-op complications due to tenotomy
Full Information
NCT ID
NCT04897100
First Posted
May 18, 2021
Last Updated
May 8, 2023
Sponsor
Indus Hospital and Health Network
1. Study Identification
Unique Protocol Identification Number
NCT04897100
Brief Title
Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot
Official Title
Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indus Hospital and Health Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Club Foot, Achilles Tendon Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
244 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Needle tenotomy
Arm Type
Experimental
Arm Description
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.
Arm Title
Blade tenotomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Achilles tendon tenotomy
Intervention Description
Achilles tendon tenotomy during Ponseti treatment for clubfoot
Primary Outcome Measure Information:
Title
Dorsiflexion
Description
Ankle dorsiflexion measured in degrees
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Complications
Description
Post-op complications due to tenotomy
Time Frame
3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Refusal of parents to enroll child into this study.
Syndromic clubfoot.
Previous treatment for clubfoot (surgical or non-surgical) received.
Underlying medical conditions unrelated to clubfoot that may serve as a contra-indication, this decision will be left on the discretion of the treating orthopedic surgeon
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sadia Ahmed
Phone
+923442182741
Email
sadia.ahmed@tih.org.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mansoor Khan
Organizational Affiliation
Indus Hospital and Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indus Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadia Ahmed
Phone
+923442182741
Email
sadia.ahmed@ghd.ihn.org.pk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The participant data will be made available in an anonymous manner as a supplement to the final publication
Learn more about this trial
Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot
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