Clinical trial Recruiting at 1 site Interventional Ages 16 and up

Wrist position in a 3D-printed dorsal blocking splint after flexor tendon repair

Official title: Effects of Different Wrist Positions in 3D-Printed Dorsal Blocking Orthoses on Clinical and Functional Outcomes After Zone I-II Flexor Tendon Repair: A Randomized Controlled Study

Run by Gazi University · NCT07489235 · Data updated 2026-11-12

This trial tests whether three wrist angles (30° extension, neutral, or 30° flexion) in a 3D-printed dorsal blocking orthosis affect recovery after zone I–II flexor tendon repair in adults.

Quick facts

Study typeInterventional
Ages16 Years and up
SexAll
Enrollment64 (estimated)
SponsorGazi University
Academic / other
Locations1 site (Ankara)
StatusRecruiting
StartedApril 20, 2026
Main results expectedMarch 6, 2028
Study endsAugust 6, 2028
Registry record updatedSeptember 8, 2026
Trial IDNCT07489235 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 16 years and older who had zone I–II flexor tendon repair with a four-strand suture technique and can begin a controlled early mobilization protocol, including Turkish-speaking participants with adequate cognitive function.

Probably not a fit

Patients not meeting eligibility or those with conditions that preclude orthosis use or early mobilization may not experience benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study compares three wrist positions in a dorsal blocking orthosis used during early active mobilization after zone I–II flexor tendon repair. Fifty-four participants are randomly assigned to one of three groups, with all groups following the same rehabilitation protocol. Outcomes such as total active motion, pain, complications, functional status, and orthosis satisfaction are assessed at 6, 8, and 12 weeks by a blinded assessor. The trial uses 3D-printed orthoses and targets adults who recently underwent repair and are eligible for early mobilization. The results may inform optimal immobilization angles to balance movement with protection.

Why it matters

Potential benefit: If successful, the study could identify the wrist position that best supports healing and functional recovery during early therapy after flexor tendon repair.

How similar studies have gone: Previous work in tendon rehab has explored orthosis position effects, but this study adds randomized comparison with 3D-printed splints in early mobilization settings.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Gazi University
    Ankara, Turkey (Türkiye)
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Virtual reality rehab with early active mobilization after flexor tendon repair

    This study tests whether adding virtual reality–based rehabilitation to an early active mobilization plan helps people recover finger movement, strength, and less pain after flexor tendon repair.

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  • Extracorporeal shock wave therapy after flexor tendon repair in the hand

    This will test whether adding extracorporeal shock wave therapy to standard rehabilitation helps people 8–12 weeks after flexor tendon repair in the hand regain motion, reduce pain, and improve grip and dexterity.

    Recruiting Kirsehir Ahi Evran Universitesi · Ankara · NCT07320807

  • Rehabilitation comparison after thumb flexor tendon repair

    This tests whether starting early active motion or keeping the thumb in a plaster cast for four weeks works better after surgery for a torn thumb flexor tendon in people older than 15.

    Recruiting at 5 sites Karolinska Institutet · Linköping and 4 other locations · NCT06836349

  • Evaluating outcomes of flexor tendon injury treatments

    This study is looking at how well different treatments for finger and thumb tendon injuries work by tracking recovery and therapy results from patients over several years.

    Recruiting University of Zurich · Zurich, Canton of Zurich · NCT04312412

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.