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 type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Gazi University Academic / other |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | March 6, 2028 |
| Study ends | August 6, 2028 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT07489235 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
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Gazi University
Ankara, Turkey (Türkiye) Recruiting
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.