Camptodactyly Syndrome Guadalajara Type 1 Clinical Trials

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Treatment of Camptodactyly With Radial Longitudinal Flap Versus Full-Thickness Skin Graft: A Randomized, Parallel, Superiority Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this randomized clinical trial is to compare two surgical techniques used for skin coverage after surgical correction of camptodactyly, a condition in which one or more fingers remain bent and cannot be fully straightened. The study will include children and adolescents with camptodactyly who have a proximal interphalangeal joint flexion contracture of 30 degrees or more and an indication for surgical treatment. The main question the study aims to answer is: \- Does a radial longitudinal flap provide better gain and maintenance of finger extension six months after surgery compared with a full-thickness skin graft? The study will also evaluate: * Movement of the affected finger; * Recurrence of the deformity; * Surgical complications; * Hand function; * Patient and/or parent or caregiver satisfaction; * Adherence to rehabilitation and nighttime splint use; * Overall surgical outcome. Researchers will compare radial longitudinal flap and full-thickness skin graft to determine whether the radial longitudinal flap provides better maintenance of finger correction. Participants will: * Undergo the surgical treatment indicated for camptodactyly, with skin coverage using either a radial longitudinal flap or a full-thickness skin graft, according to randomization; * Be evaluated before surgery and at 2, 4, 8, and 12 weeks and 6 months after surgery; * Have movement of the affected finger assessed using standardized goniometry; * Follow the postoperative rehabilitation protocol, including occupational therapy and nighttime extension splint use; * Complete assessments of hand function and satisfaction at the scheduled evaluation periods. * Approximately 42 eligible fingers will be randomized, with 21 fingers allocated to each treatment group. If a participant has more than one eligible finger, each eligible finger may be randomized independently.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosis of camptodactyly.

• Flexion contracture of the proximal interphalangeal joint ≥30°.

• Indication for surgical treatment.

• Written informed consent from adult participants or from parents/legal guardians for minors.

• Assent from minor participants, when applicable.

Locations
Other Locations
Brazil
AACD
RECRUITING
São Paulo
Contact Information
Primary
Renato TS Moretto, Hand Surgeon
rmoretto@uol.com.br
5511964214000
Backup
Bruna S Bezerra, Hand Surgeon
bruna.ortopedista@gmail.com
551181116019
Time Frame
Start Date: 2026-09-02
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 42
Treatments
Experimental: Radial Longitudinal Flap
Participants randomized to this arm will undergo surgical correction of camptodactyly with standardized stepwise release of the contracted structures. After adequate release and correction of the proximal interphalangeal joint contracture, the resulting skin defect will be covered using a radial longitudinal flap to provide local soft-tissue coverage of the volar aspect of the affected finger. Postoperative immobilization and rehabilitation will be performed according to the standardized study protocol, including occupational therapy and nighttime extension splint use. Participants will undergo clinical assessments before surgery and at 2, 4, 8, and 12 weeks and 6 months after surgery.
Active_comparator: Full-Thickness Skin Graft
Participants randomized to this arm will undergo surgical correction of camptodactyly with standardized stepwise release of the contracted structures. After adequate release and correction of the proximal interphalangeal joint contracture, the resulting skin defect will be covered using a full-thickness skin graft. The graft will be harvested from the wrist flexion crease or hypothenar region, according to the standardized surgical protocol. Postoperative immobilization and rehabilitation will be performed according to the standardized study protocol, including occupational therapy and nighttime extension splint use. Participants will undergo clinical assessments before surgery and at 2, 4, 8, and 12 weeks and 6 months after surgery.
Sponsors
Leads: Associação de Assistência a Criança Deficiente

This content was sourced from clinicaltrials.gov