Club FootNCT04897100
Outcome After Needle vs Blade Achilles Tenotomy in Clubfoot
A study testing Achilles tendon tenotomy in people with Club Foot and Achilles Tendon Surgery, run by Indus Hospital and Health Network at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Club Foot, Achilles Tendon Surgery
- What is being tested?
- Achilles tendon tenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Mar 2020to 16 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method
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.
- Conditions
- Club Foot, Achilles Tendon Surgery
- Being tested
- Achilles tendon tenotomy
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Achilles tendon tenotomyProcedure or surgery
Achilles tendon tenotomy during Ponseti treatment for clubfoot
| Study group | Role | What they receive |
|---|---|---|
| Needle tenotomy | Experimental | 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. Receives: Procedure: Achilles tendon tenotomy |
| Blade tenotomy | Active comparator | 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. Receives: Procedure: Achilles tendon tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsiflexion
Ankle dorsiflexion measured in degrees
Measured: 3 months
Secondary outcomes (1)
Complications
Post-op complications due to tenotomy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start27 Mar 2020
- Primary completion2 Sep 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Club FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indus Hospital and Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mansoor Khan, Principal investigator, Indus Hospital and Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897100
- Sponsor's protocol ID
- IRD_IRB_2020_03_011
- Status last verified
- Mar 2024
- First submitted
- 18 May 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The participant data will be made available in an anonymous manner as a supplement to the final publication
Publications
Pigeolet M, Ghufran Syed J, Ahmed S, Chinoy MA, Khan MA. A single-center, single-blinded, randomized, parallel-group, non-inferiority trial to compare the efficacy of a 22-gauge needle versus a 15 blade to perform an Achilles tendon tenotomy in 244 clubfeet-study protocol. Trials. 2023 Oct 31;24(1):701. doi: 10.1186/s13063-023-07728-9.
PubMed 37907927
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome and Complications After Percutaneous Needle Versus Blade Achilles Tenotomy in Clubfoot Treated With the Ponseti Method
- ClinicalTrials.gov ID
- NCT04897100
- Acronym / sponsor ID
- IRD_IRB_2020_03_011
- Conditions
- Club Foot, Achilles Tendon Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Indus Hospital and Health NetworkUniversity, hospital or other
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle tenotomy | Experimental | Procedure: Achilles tendon tenotomyPatient 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. |
| Blade tenotomy | Active comparator | Procedure: Achilles tendon tenotomyPatient 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. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Achilles tendon tenotomyAchilles tendon tenotomy during Ponseti treatment for clubfoot | Procedure or surgery | Blade tenotomy, Needle tenotomy |
Primary outcome
Dorsiflexion
Time frame: 3 months
Ankle dorsiflexion measured in degrees
1 secondary outcome
Complications
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 37907927Pigeolet M, Ghufran Syed J, Ahmed S, Chinoy MA, Khan MA. A single-center, single-blinded, randomized, parallel-group, non-inferiority trial to compare the efficacy of a 22-gauge needle versus a 15 blade to perform an Achilles tendon tenotomy in 244 clubfeet-study protocol. Trials. 2023 Oct 31;24(1):701. doi: 10.1186/s13063-023-07728-9.
- Individual participant dataSharing planned: Yes. The participant data will be made available in an anonymous manner as a supplement to the final publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansoor Khan principal investigator
Indus Hospital and Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Achilles tendon tenotomy in people with Club Foot and Achilles Tendon Surgery, run by Indus Hospital and Health Network at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dorsiflexion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04897100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.