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

NCT07786701 | Not Yet Recruiting

• 2 other identifiers: 314.2026CAAE: 99290226.2.0000.0085
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Camptodactyly

Keywords

Camptodactyly; Hand Surgery; Radial Longitudinal Flap; Full-Thickness Skin Graft; Randomized Clinical Trial; Congenital Hand Deformity

Outcome Measures

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.

  From baseline (preoperative assessment) to 6 months after surgery

Secondary Outcomes (8)

• Active and Passive Range of Motion of the Proximal Interphalangeal Joint

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

• Recurrence of Camptodactyly

  2, 4, 8, and 12 weeks, and 6 months after surgery

• Postoperative Complications

  From surgery through 6 months after surgery

• Upper Extremity Function

  Baseline and 6 months after surgery

• Patient or Caregiver Satisfaction

  6 months after surgery

Study Arms (2)

Radial Longitudinal Flap

EXPERIMENTAL

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.

Procedure: Radial Longitudinal Flap

Full-Thickness Skin Graft

ACTIVE COMPARATOR

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.

Procedure: Full-Thickness Skin Graft

Interventions

Radial Longitudinal Flap PROCEDURE

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.

Radial Longitudinal Flap

Full-Thickness Skin Graft PROCEDURE

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.

Full-Thickness Skin Graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Associated syndromes that may interfere with isolated assessment of camptodactyly (e.g., arthrogryposis).
• Previous surgery on the affected finger.
• Irreversible fixed joint stiffness.

Sponsors & Collaborators

• Associação de Assistência a Criança Deficiente: lead

Study Sites (1)

AACD

São Paulo, São Paulo, 04026001, Brazil

Location

Related Publications (5)

• Wall LB, Ezaki M, Goldfarb CA. Camptodactyly Treatment for the Lesser Digits. J Hand Surg Am. 2018 Sep;43(9):874.e1-874.e4. doi: 10.1016/j.jhsa.2018.03.023. Epub 2018 Apr 22.

  PMID: 29691077 BACKGROUND

• Morimoto Y, Sogabe Y, Kawabata A, Takamatsu K. Digital artery perforator flap transfer for volar soft tissue defect due to dissociation from joint contracture in camptodactyly. JPRAS Open. 2020 Nov 30;27:48-52. doi: 10.1016/j.jpra.2020.11.009. eCollection 2021 Mar.

  PMID: 33319010 BACKGROUND

• Liao W, Wang L, Tang Y, Jiang L, Guo R, Zhuang H, Tang K, Zheng P. Modified radial tongue-shaped flap following stepwise surgical release for Benson type I camptodactyly of the 5th digit. Sci Rep. 2023 Mar 9;13(1):3927. doi: 10.1038/s41598-023-31138-1.

  PMID: 36894622 BACKGROUND

• Evans BT, Waters PM, Bae DS. Early Results of Surgical Management of Camptodactyly. J Pediatr Orthop. 2017 Jul/Aug;37(5):e317-e320. doi: 10.1097/BPO.0000000000000967.

  PMID: 28277466 BACKGROUND

• Yannascoli SM, Goldfarb CA. Treating Congenital Proximal Interphalangeal Joint Contracture. Hand Clin. 2018 May;34(2):237-249. doi: 10.1016/j.hcl.2017.12.013.

  PMID: 29625643 BACKGROUND

Related Links

• Look for "camptodactilia" in the field "Título da Pesquisa:" and "moretto" in the "Pesquisador Principal:" filed. This will show the registry of this study.

MeSH Terms

Conditions

Hand Deformities, Congenital

Condition Hierarchy (Ancestors)

Hand Deformities; Musculoskeletal Diseases; Upper Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Renato TS Moretto, Hand Surgeon

CONTACT

5511964214000; rmoretto@uol.com.br

Bruna S Bezerra, Hand Surgeon

CONTACT

551181116019; bruna.ortopedista@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Head Hand Surgeon

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 26, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)