ClubfootNCT07561736
Comparison of Surgical Blade No. 11 and Ophthalmic Knife in Idiopathic Clubfoot Patients
An observational study of Clubfoot, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
There is limited local data available on the comparison between surgical blade no.11 and ophthalmic knife among patients with neglected clubfoot going through tenotomy. The study has been planned with the objective of comparing the effectiveness of surgical blade no. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Clubfoot
- What is being tested?
- Surgical Blade and Ophthalmic Knife
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2025to 30 Jun 2026
- Phase
- Observational
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Newly diagnosed patients of clubfoot less than 6 months of age and having the Pirani score 3-6 within the study period were recruited.
Who may be able to join
- Any gender
- Aged 2-5 years
- Diagnosed with clubfoot
Who cannot join
- Children with other neuromuscular
- Chromosomal abnormalities
- Arthrogryposis multiplex congenita
- Myelomeningocele
- Dystrophic dysplasia
- Moebius syndrome
Show all 10Show fewer
- Amniotic band syndrome
- Metatarsus adductus
- Syndactyly
- Polydactyly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effectiveness of Surgical Blade No. 11 and Ophthalmic Knife for Percutaneous Achilles Tendon Tenotomy in Idiopathic Clubfoot Patients
There is limited local data available on the comparison between surgical blade no.11 and ophthalmic knife among patients with neglected clubfoot going through tenotomy. The study has been planned with the objective of comparing the effectiveness of surgical blade no. 11 and ophthalmic knife for percutaneous Achilles tendon tenotomy in Idiopathic clubfoot patients
Read the detailed description
Percutaneous Achilles tendon tenotomy is performed using surgical blade no. 11. However, concerns regarding incision size, bleeding, and scarring have led to exploration of alternative instruments. Previously, comparative studies have been conducted on a 22-gauge needle vs. a surgical blade. However, an ophthalmic knife, designed for microsurgical precision, offers a fine tip and elongated handle, allowing improved control during tendon release with a small incision and precision. Previous studies have compared blade and needle techniques and ophthalmic knives for percutaneous tenotomy of the Achilles tendon done on animals. The study findings would be helpful in opting for a better instrument for the procedure that should be effective and have a better safety profile.
- Conditions
- Clubfoot
- Being tested
- Surgical Blade, Ophthalmic Knife
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical BladeDevice
Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with surgical blade no. 11.
Ophthalmic KnifeDevice
Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with ophthalmic knife.
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with surgical blade no. 11. Receives: Device: Surgical Blade | |
| Group-B | Patients after serial casting and manipulation according to the Ponseti method went through tenotomy with ophthalmic knife. Receives: Device: Ophthalmic Knife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ankle dorsiflexion
Frequency of patients who had improved Pirani score was noted.
Measured: 3 months after surgery
Secondary outcomes (3)
Bleeding
Frequencies of patients who had bleeding severity as none, mild, moderate, or excessive, were noted.
Measured: 1 hour after surgery
Infection
The frequency of patients who had infected wound was noted.
Measured: 3 months after surgery
Incomplete Tenotomy
Frequency of patients who had incomplete release or residual deformity was assessed.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Nov 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Pervez Ali, FCPS, Study director, Jinnah Postgraduate Medical Centre, Karachi, PakistanSidratul Zaitoon, Principal investigator, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561736
- Sponsor's protocol ID
- Dr-Pervez-Karachi
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Surgical Blade No. 11 and Ophthalmic Knife for Percutaneous Achilles Tendon Tenotomy in Idiopathic Clubfoot Patients
- ClinicalTrials.gov ID
- NCT07561736
- Acronym / sponsor ID
- Dr-Pervez-Karachi
- Conditions
- Clubfoot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 1 May 2026 (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.
There is limited local data available on the comparison between surgical blade no.11 and ophthalmic knife among patients with neglected clubfoot going through tenotomy. The study has been planned with the objective of comparing the effectiveness of surgical blade no. 11 and ophthalmic knife for percutaneous Achilles tendon tenotomy in Idiopathic clubfoot patients
Detailed description
Percutaneous Achilles tendon tenotomy is performed using surgical blade no. 11. However, concerns regarding incision size, bleeding, and scarring have led to exploration of alternative instruments. Previously, comparative studies have been conducted on a 22-gauge needle vs. a surgical blade. However, an ophthalmic knife, designed for microsurgical precision, offers a fine tip and elongated handle, allowing improved control during tendon release with a small incision and precision. Previous studies have compared blade and needle techniques and ophthalmic knives for percutaneous tenotomy of the Achilles tendon done on animals. The study findings would be helpful in opting for a better instrument for the procedure that should be effective and have a better safety profile.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | – | Device: Surgical BladePatients after serial casting and manipulation according to the Ponseti method went through tenotomy with surgical blade no. 11. |
| Group-B | – | Device: Ophthalmic KnifePatients after serial casting and manipulation according to the Ponseti method went through tenotomy with ophthalmic knife. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newly diagnosed patients of clubfoot less than 6 months of age and having the Pirani score 3-6 within the study period were recruited.
Key inclusion criteria (3 listed)
- Any gender
- Aged 2-5 years
- Diagnosed with clubfoot
Key exclusion criteria (10 listed)
- Children with other neuromuscular
- Chromosomal abnormalities
- Arthrogryposis multiplex congenita
- Myelomeningocele
- Dystrophic dysplasia
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 |
|---|---|---|
| Surgical BladePatients after serial casting and manipulation according to the Ponseti method went through tenotomy with surgical blade no. 11. | Device | Group-A |
| Ophthalmic KnifePatients after serial casting and manipulation according to the Ponseti method went through tenotomy with ophthalmic knife. | Device | Group-B |
Primary outcome
Improvement in ankle dorsiflexion
Time frame: 3 months after surgery
Frequency of patients who had improved Pirani score was noted.
3 secondary outcomes
Bleeding
Time frame: 1 hour after surgery
Infection
Time frame: 3 months after surgery
Incomplete Tenotomy
Time frame: 3 months after surgery
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 17 Jul 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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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.
Pervez Ali, FCPS study director
Jinnah Postgraduate Medical Centre, Karachi, Pakistan
Sidratul Zaitoon principal investigator
Jinnah Postgraduate Medical Centre, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clubfoot, run by Muhammad Aamir Latif 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 3 inclusion and 10 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 17 Jul 2026. 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?
Improvement in ankle dorsiflexion (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.