Treatment of Camptodactyly With Radial Longitudinal Flap Versus Full-Thickness Skin Graft

ConditionCamptodactyly
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssociação de Assistência a Criança Deficiente

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Associated syndromes that may interfere with isolated assessment of camptodactyly (e.g., arthrogryposis).

Previous surgery on the affected finger.

Irreversible fixed joint stiffness.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radial Longitudinal Flap

    Procedure/Surgery

    Surgical coverage of the skin defect created after standardized release of the contracted structures in patients with camptodactyly, using a radial longitudinal flap raised from the radial aspect of the affected finger and transposed to cover the resulting volar defect.

  • Full-Thickness Skin Graft

    Procedure/Surgery

    Surgical coverage of the skin defect created after standardized release of the contracted structures in patients with camptodactyly, 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Radial Longitudinal FlapExperimental treatment 1 intervention
Group B: Full-Thickness Skin GraftActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maintenance of proximal interphalangeal joint extension

The primary outcome will be the gain and maintenance of proximal interphalangeal joint extension, measured by goniometry in degrees.

Time frame
From baseline (preoperative assessment) to 6 months after surgery

Secondary outcomes

1

Active and Passive Range of Motion of the Proximal Interphalangeal Joint

Active and passive range of motion of the proximal interphalangeal joint will be measured by goniometry in degrees at each postoperative assessment.

Time frame
Baseline, 2, 4, 8, and 12 weeks, and 6 months after surger
2

Recurrence of Camptodactyly

Recurrence will be defined as a loss of more than 20 degrees of the extension achieved immediately after surgery, measured by goniometry during follow-up.

Time frame
2, 4, 8, and 12 weeks, and 6 months after surgery
3

Postoperative Complications

Postoperative complications will include partial or total flap or graft necrosis, wound dehiscence, infection requiring antibiotic treatment, residual pain, and joint stiffness. Partial necrosis will be defined as loss of viability involving less than 50% of the flap or graft area, and total necrosis as loss involving more than 50%. Joint stiffness will be defined as a loss of more than 20 degrees of range of motion compared with the immediate postoperative assessment.

Time frame
From surgery through 6 months after surgery
4

Upper Extremity Function

Upper extremity function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH) questionnaire. The questionnaire will be administered preoperatively and at 6 months after surgery, when appropriate according to the participant's age and ability to complete the instrument.

Time frame
Baseline and 6 months after surgery

Other outcomes

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