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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-A | Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with surgical blade no. 11. |
| |
| Group-B | Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with ophthalmic knife. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Blade | Device | Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with surgical blade no. 11. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in ankle dorsiflexion | The frequency of patients will be noted who will have improved Pirani score. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | The frequency of patients will be noted who will have bleeding severity as none, mild, moderate, or excessive. | 1 hour |
| Infection | The frequency of patients will be noted who will have infected wound. |
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Inclusion Criteria:
Exclusion Criteria:
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Newly diagnosed patients of clubfoot less than 6 months of age and having the Pirani score 3-6 within the study period were recruited.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pervez Ali, FCPS | Contact | +923333001737 | pervez73@hotmail.com | |
| Sidratul Zaitoon | Contact | +923150012163 | sidra9503@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pervez Ali, FCPS | Jinnah Postgraduate Medical Centre, Karachi, Pakistan | Study Director |
| Sidratul Zaitoon | Jinnah Postgraduate Medical Centre, Karachi, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinnah Postgraduate Medical Centre | Completed | Karachi | Sindh | 75510 | Pakistan | |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D003025 | Clubfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| Ophthalmic Knife | Device | Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with ophthalmic knife. |
|
| 3 months |
| Incomplete Tenotomy | Frequency of patients who will have incomplete release or residual deformity assessed after 3 | 3 months |
| Jinnah Postgraduate Medical Centre |
| Recruiting |
| Karachi |
| Sindh |
| 75510 |
| Pakistan |
|
| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |