Ireland
--:--IST
Recruiting Not applicable

Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair

NCT07489235 · tracked via the Priya Life Science Turkey tracker
Sponsor
Sedanur Güngör
Phase
Not applicable
Started
2026-04-20
Last updated
2026-09-08

Condition(s) studied

Flexor Tendon InjuryTendon Injury - Hand

Investigational drug(s) / intervention(s)

3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension)3D-Printed Dorsal Blocking Orthosis (wrist neutral)3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion)

3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension): Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.

3D-Printed Dorsal Blocking Orthosis (wrist neutral): Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.

3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion): Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.

Study summary

This randomized controlled study aims to compare the effects of three different wrist positions (30° extension, neutral, and 30° flexion) used in dorsal blocking orthoses during early active mobilization after zone I-II flexor tendon repair. A total of 54 patients will be randomly assigned into three groups. All participants will receive the same rehabilitation protocol. Clinical and functional outcomes including total active motion, pain, complications, functional status, and orthosis satisfaction will be evaluated at 6, 8, and 12 weeks by a blinded assessor.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Individuals aged 16 years and older * Patients who underwent zone I or II flexor tendon repair using at least a four--strand suture technique * Referral to physiotherapy within the first 10 days after surgery * Eligibility for a controlled early active mobilization protocol * Ability to understand and complete Turkish assessment questionnaires * Adequate cognitive function (Montreal Cognitive Assessment score \>21) * Voluntary participation with written informed consent Exclusion Criteria: * Thumb tendon repairs * Multiple or complex injuries (e.g., concomitant peripheral nerve injury, fractures requiring immobilization, joint dislocation, extensor tendon injury) * Active infection * Severe edema preventing orthosis use * Dermatological conditions or allergies preventing orthosis application * Systemic diseases that may affect rehabilitation (e.g., diabetes mellitus, -peripheral neuropathy, stroke, advanced rheumatoid arthritis) * Pre-existing wrist pain or deformity prior to injury * Inability to attend follow-up assessments * Non-compliance with the home exercise program

Primary outcome measure(s)

  • Total Active Motion (TAM) — 12 week
    Total active motion will be calculated by summing the active flexion angles of the metacarpophalangeal, proximal interphalangeal, and distal interphalangeal joints and subtracting any extension deficits. Measurements will be performed using a finger goniometer and evaluated according to the Buck-Gramcko classification.

Trial sites (1)

FacilityCityRegionStatus
Gazi University Ankara Turkey (Türkiye) Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07489235 on ClinicalTrials.gov ↗ ← All trials in Turkey