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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 1/8/2026 | Other Identifier | UW Madison | |
| SMPH/ORTHO&REHAB/ORTHO | Other Identifier | UW Madison |
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The purpose of this study is to assess if the application of Mastisol, a liquid adhesive, improves outcomes during bilateral clubfoot casting and reduces complications and development of complex clubfoot for the duration of their casting and up to 5 years follow-up.
Study Objectives include:
The investigators hypothesize that Mastisol application will be associated with improved outcomes by helping to maintain a well-fitting cast, which can be key to reducing complications, optimizing correction (i.e. minimizing treatment time). Proper correction can ultimately be associated with decreased incidence of clubfoot recurrence and need for reconstruction.
Participants' participation will last roughly 8-12 weeks but may be shorter or longer depending on their response to manipulation and casting. This is a standard expectation with the Ponseti method of clubfoot casting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leg with Mastisol | Experimental |
| |
| Control Leg | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mastisol | Device | a liquid adhesive used to secure dressings for extended periods of time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Weeks Need to Obtain Correction | up to 12 weeks | |
| Incidence of recurrent casting or tenotomy | follow up to 5 years from medical records | |
| Incidence of reconstructive surgery | follow up to 5 years from medical records |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Casts to Correction | up to 12 weeks | |
| Number of times that each leg has unplanned re-casting in between visits | up to 12 weeks | |
| Tibio-calcaneal angle measured from radiograph at tenotomy time point |
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Inclusion Criteria:
Patients with bilateral clubfeet
Starting standard of care treatment with the Ponseti method between 0-12 weeks of age
Patients for whom at least one parent/guardian is able to converse, read, and write in English
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ava Barker | Contact | (608)-263-2356 | barker@ortho.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Touhy, MD | UW School of Medicine and Public Health | Principal Investigator |
| Kenneth Noonan, MD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW-Health Pediatric Orthopedics Clinics | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| Mastisol Liquid Adhesive | View source |
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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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a single group of infant participants will have the intervention randomized to either their left or their right leg
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| up to 12 weeks |
| Dorsiflexion angle measure from radiograph at tenotomy time point | up to 12 weeks |
| Incidence of Adverse Events | sores, redness, swelling, irritation, obvious slippage | up to 12 weeks |
| Incidence of Severe Adverse Events | severe dermatitis | up to 12 weeks |
| Incidence of formation of complex clubfoot | up to 12 weeks |
| 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 |