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NCT07786701
Treatment of Camptodactyly With Radial Longitudinal Flap Versus Full-Thickness Skin Graft
Conditions: Camptodactyly
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 42
Sponsor: Associação de Assistência a Criança Deficiente
Location: AACD São Paulo São Paulo
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 Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Associated syndromes that may interfere with isolated assessment of camptodactyly (e.g., arthrogryposis).
* Previous surgery on the affected finger.
* Irreversible fixed joint stiffness.
Source: ClinicalTrials.gov (NCT07786701). StuddyBuddy aggregates publicly available trial information.