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Not yet recruiting NCT07489235

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

No phase Interventional Flexor Tendon Injury Tendon Injury - Hand

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Flexor Tendon Injury, Tendon Injury - Hand. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device 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.
  • Device 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.
  • Device 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.

Primary outcome measures

  • Total Active Motion (TAM) [Time frame: 12 week]
Secondary outcome measures (8)
  • Pain Intensity [Time frame: 6, 8, and 12 weeks]
  • Hand Function [Time frame: 6, 8 and 12 weeks]
  • Upper Extremity Function [Time frame: 6, 8, and 12 weeks]
  • Grip Strength [Time frame: 6, 8, and 12 weeks]
  • Pinch Strength [Time frame: 6, 8, and 12 weeks]
  • Orthosis Satisfaction [Time frame: 6 weeks]
  • Complications [Time frame: up to 12 weeks]
  • Return to Daily Activities [Time frame: Up to 12 weeks]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07489235 · 2025 - 2170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗