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

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

Camptodactyly is a congenital hand deformity characterized by flexion contracture of the proximal interphalangeal (PIP) joint, resulting in an inability to fully extend the affected finger. The condition may involve one or more fingers and may be unilateral or bilateral. Although conservative treatment is preferred in many cases, surgical treatment may be indicated in patients with persistent, moderate, or severe deformity and functional limitation.

Surgical correction generally involves release of contracted structures responsible for the deformity. Following release, a skin defect may remain on the volar aspect of the finger and requires appropriate soft tissue coverage. Full-thickness skin grafting is a commonly used technique; however, secondary scar contraction may contribute to loss of correction or recurrence of the deformity. A radial longitudinal flap provides local tissue coverage and may offer advantages related to tissue elasticity, vascularity, and resistance to secondary contracture.

This study is a prospective, randomized, parallel-group, superiority clinical trial designed to compare radial longitudinal flap coverage with full-thickness skin graft coverage following surgical correction of camptodactyly.

Eligible fingers will be randomly allocated in a 1:1 ratio to one of two treatment groups. Randomization will be performed using a computer-generated sequence with block randomization. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Randomization will occur at the level of the eligible finger rather than at the participant level.

When a participant has more than one eligible finger, each eligible finger may be randomized independently. Therefore, a single participant may contribute more than one randomized finger and may potentially receive different treatment techniques for different eligible fingers. The potential correlation between fingers belonging to the same participant will be considered during statistical analysis.

All participants will undergo the surgical treatment indicated for their camptodactyly according to the standardized study protocol. After release of the contracted structures, participants will receive skin coverage according to their randomized treatment allocation.

In the experimental group, the skin defect will be covered using a radial longitudinal flap. In the comparator group, the skin defect will be covered using a full-thickness skin graft obtained from an appropriate donor site according to the surgical protocol.

Postoperative care will follow a standardized rehabilitation protocol. Participants will receive appropriate immobilization and occupational therapy, including exercises directed at maintaining and improving finger range of motion. Nighttime extension splint use will also be prescribed according to the postoperative protocol.

Clinical assessments will be performed before surgery and during postoperative follow-up at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 6 months. Finger range of motion will be assessed using standardized goniometry. The main objective is to determine whether the radial longitudinal flap provides greater maintenance of PIP joint extension at 6 months compared with full-thickness skin grafting.

Postoperative assessments will be performed by an occupational therapist who will be blinded to treatment allocation. To maintain blinding, the operated finger and donor area will be covered with a self-adherent elastic bandage before assessment, preventing the evaluator from identifying the type of skin coverage used.

In addition to range of motion, the study will evaluate recurrence of the deformity, postoperative complications, hand function, patient and/or parent or caregiver satisfaction, adherence to occupational therapy, nighttime splint use, and overall surgical outcome according to the clinical classification proposed by Siegert et al.

Participants who discontinue follow-up, withdraw consent, or do not complete all scheduled assessments will not be considered excluded from the study after enrollment. They will be recorded as losses to follow-up or study discontinuations, including the reason whenever available. Data collected before discontinuation will be retained and analyzed according to the statistical analysis plan and applicable ethical requirements.

The study is intended to determine whether radial longitudinal flap coverage provides superior maintenance of surgical correction compared with full-thickness skin grafting. The findings may contribute to improving the surgical management of children and adolescents with camptodactyly and help inform the choice of soft tissue coverage following surgical release.

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.