Flexor Tendon InjuryNCT07489235
Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair
A study testing 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension), 3D-Printed Dorsal Blocking Orthosis (wrist neutral) and 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion) in people with Flexor Tendon Injury and Tendon Injury - Hand, run by Sedanur Güngör at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Flexor Tendon Injury, Tendon Injury - Hand
- What is being tested?
- 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension), 3D-Printed Dorsal Blocking Orthosis (wrist neutral) and 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 6 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Pre-existing wrist pain or deformity prior to injury
- Inability to attend follow-up assessments
- Non-compliance with the home exercise program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University
Ankara
Zeynep Emir, +90 505 731 52 40, zeyneptuna@gazi.edu.tr
About this study
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
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.
- Conditions
- Flexor Tendon Injury, Tendon Injury - Hand
- Being tested
- 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)
- Keywords
- flexor tendon, orthosis, splint, 3D printing, therapy, rehabilitation, immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension)Device
Also called Early Active Mobilization Protocol
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)Device
Also called Early Active Mobilization Protocol
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)Device
Also called Early Active Mobilization Protocol
Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol.
| Study group | Role | What they receive |
|---|---|---|
| Wrist Extension Group | Experimental | Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol. Receives: Device: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension) |
| Neutral Wrist Group | Experimental | Participants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol. Receives: Device: 3D-Printed Dorsal Blocking Orthosis (wrist neutral) |
| Wrist Flexion Group | Experimental | Participants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol. Receives: Device: 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Active Motion (TAM)
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.
Measured: 12 week
Secondary outcomes (8)
Pain Intensity
Pain intensity will be assessed using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
Measured: 6, 8, and 12 weeks
Hand Function
Hand function will be evaluated using the Jebsen-Taylor Hand Function Test, which measures the time required to complete standardized hand tasks.
Measured: 6, 8 and 12 weeks
Upper Extremity Function
Upper extremity functional status will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire. Lower scores indicate better function.
Measured: 6, 8, and 12 weeks
Grip Strength
Grip strength will be measured using a hydraulic hand dynamometer and recorded in kilograms.
Measured: 6, 8, and 12 weeks
Pinch Strength
Pinch strength will be measured using a pinch meter and recorded in kilograms.
Measured: 6, 8, and 12 weeks
Orthosis Satisfaction
Patient satisfaction with the orthosis will be assessed using the Orthotics and Prosthetics Users' Survey (OPUS).
Measured: 6 weeks
Complications
Postoperative complications including tendon rupture, adhesions, edema, and skin irritation will be recorded during the follow-up period.
Measured: up to 12 weeks
Return to Daily Activities
Time to return to daily activities and work will be recorded in weeks.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 Apr 2026
- Primary completion6 Mar 2028 (estimated)
- Study completion6 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sedanur Güngör
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Sponsor-investigator, Sedanur Güngör, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489235
- Sponsor's protocol ID
- 2025 - 2170
- Status last verified
- Sep 2026
- First submitted
- 19 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07489235
- Acronym / sponsor ID
- 2025 - 2170
- Conditions
- Flexor Tendon Injury, Tendon Injury - Hand
- Keywords
- flexor tendon, orthosis, splint, 3D printing, therapy, rehabilitation, immobilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sedanur GüngörUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 6 Mar 2028 (estimated)
- Study completion
- 6 Aug 2028 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Wrist Extension Group | Experimental | 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. |
| Neutral Wrist Group | Experimental | 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. |
| Wrist Flexion Group | Experimental | 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension)Also: Early Active Mobilization ProtocolParticipants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° extension and follow a controlled early active mobilization protocol. | Device | Wrist Extension Group |
| 3D-Printed Dorsal Blocking Orthosis (wrist neutral)Also: Early Active Mobilization ProtocolParticipants will use a 3D-printed dorsal blocking orthosis with the wrist in neutral position and follow the same rehabilitation protocol. | Device | Neutral Wrist Group |
| 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion)Also: Early Active Mobilization ProtocolParticipants will use a 3D-printed dorsal blocking orthosis with the wrist positioned at 30° flexion and follow the same rehabilitation protocol. | Device | Wrist Flexion Group |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree extension), 3D-Printed Dorsal Blocking Orthosis (wrist neutral) and 3D-Printed Dorsal Blocking Orthosis (wrist 30 degree flexion) in people with Flexor Tendon Injury and Tendon Injury - Hand, run by Sedanur Güngör at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Active Motion (TAM) (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.