AzTrials
AzTrials

CamptodactylyNCT07786701

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

A study testing Radial Longitudinal Flap and Full-Thickness Skin Graft in people with Camptodactyly, run by Associação de Assistência a Criança Deficiente at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Camptodactyly
What is being tested?
Radial Longitudinal Flap and Full-Thickness Skin Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteBrazil
Study dates
2 Sep 2026to 1 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Renato TS Moretto, Hand Surgeon contact

5511964214000

rmoretto@uol.com.br

Bruna S Bezerra, Hand Surgeon contact

551181116019

bruna.ortopedista@gmail.com

Brazil1 site, 1 recruiting
  • AACD

    São Paulo, São Paulo, 04026001

    Recruiting

Other trials in Brazil

About this study

Official title: 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:

Read more
  • 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.
Read the detailed description

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.

Conditions
Camptodactyly
Being tested
Radial Longitudinal Flap, Full-Thickness Skin Graft
Keywords
Camptodactyly, Hand Surgery, Radial Longitudinal Flap, Full-Thickness Skin Graft, Randomized Clinical Trial, Congenital Hand Deformity
Medical subject headings
Hand Deformities, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radial Longitudinal FlapProcedure or 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 GraftProcedure or 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.

Study groups in NCT07786701
Study groupRoleWhat they receive
Radial Longitudinal FlapExperimentalParticipants 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.
Receives: Procedure: Radial Longitudinal Flap
Full-Thickness Skin GraftActive comparatorParticipants 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.
Receives: Procedure: Full-Thickness Skin Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline (preoperative assessment) to 6 months after surgery

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline and 6 months after surgery

  5. Patient or Caregiver Satisfaction

    Patient or caregiver satisfaction with the postoperative result will be assessed using a visual analog scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied).

    Measured: 6 months after surgery

  6. Adherence to Nighttime Extension Splint Use

    Adherence to prescribed nighttime extension splint use will be assessed by patient or caregiver self-report. Adequate adherence will be defined as use of the splint on at least 80% of the prescribed nights.

    Measured: From initiation of rehabilitation until 6 months after surgery

  7. Adherence to Rehabilitation Protocol

    Adherence to the rehabilitation protocol will be assessed according to attendance at scheduled occupational therapy sessions. Adequate adherence will be defined as attendance at least 75% of the prescribed therapy sessions.

    Measured: From initiation of rehabilitation until 6 months after surgery

  8. Surgical Outcome According to the Siegert Classification

    Surgical outcomes will be classified according to the Siegert et al. classification as excellent, good, fair, or poor, based on correction of extension, gain in extension, loss of flexion, and overall range of motion.

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2026
  2. Study start2 Sep 2026
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07786701
Sponsor's protocol ID
314.2026
Other IDs
CAAE: 99290226.2.0000.0085
Status last verified
Sep 2026
First submitted
13 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly. Given the pediatric population and the small sample size, even de-identified individual-level data may present a risk of participant re-identification.

Publications

  • 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.

    PubMed 29691077
  • 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.

    PubMed 33319010
  • 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.

    PubMed 36894622
  • 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.

    PubMed 28277466
  • 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.

    PubMed 29625643

Questions about this trial

What is this clinical trial studying?

A study testing Radial Longitudinal Flap and Full-Thickness Skin Graft in people with Camptodactyly, run by Associação de Assistência a Criança Deficiente at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Renato TS Moretto, Hand Surgeon (5511964214000, rmoretto@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maintenance of proximal interphalangeal joint extension (time frame: From baseline (preoperative assessment) to 6 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07786701, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in