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NCT Number: NCT07489235

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

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.

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Key information

Conditions

Flexor Tendon Injury Tendon Injury - Hand

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol.

Other names: Early Active Mobilization Protocol

3D-Printed Dorsal Blocking Orthosis (wrist neutral)

Device

Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol.

Other names: Early Active Mobilization Protocol

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

Device

Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.

Other names: Early Active Mobilization Protocol

Primary outcomes

  1. Total Active Motion (TAM)

    Time frame: 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.

Secondary outcomes

  1. Pain Intensity

    Time frame: 6, 8, and 12 weeks

    Pain intensity will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).

  2. Hand Function

    Time frame: 6, 8 and 12 weeks

    Hand function will be evaluated using the Jebsen-Taylor Hand Function Test, which measures the time required to complete standardized hand tasks.

  3. Upper Extremity Function

    Time frame: 6, 8, and 12 weeks

    Upper extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. Lower scores indicate better function.

  4. Grip Strength

    Time frame: 6, 8, and 12 weeks

    Grip strength will be measured using a hydraulic hand dynamometer and recorded in kilograms.

  5. Pinch Strength

    Time frame: 6, 8, and 12 weeks

    Pinch strength will be measured using a pinch meter and recorded in kilograms.

  6. Orthosis Satisfaction

    Time frame: 6 weeks

    Patient satisfaction with the orthosis will be assessed using the Orthotics and Prosthetics Users' Survey (OPUS).

  7. Complications

    Time frame: up to 12 weeks

    Postoperative complications including tendon rupture, adhesions, edema, and skin irritation will be recorded during the follow-up period.

  8. Return to Daily Activities

    Time frame: Up to 12 weeks

    Time to return to daily activities and work will be recorded in weeks.

Sponsors and collaborators

Lead sponsor

Sedanur Güngör

Other

Collaborators

  • Gazi University Scientific Research Unit

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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