Flexor Tendon InjuryNCT06836349
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
A study testing Early active motion training after operated FPL injury and Immobilisation in plaster cast 4 weeks after operated FPL injury in people with Flexor Tendon Injury and Rehabilitation Program, run by Karolinska Institutet at 5 sites in Sweden.
Trial summary
Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Flexor Tendon Injury, Rehabilitation Program, Flexor Tendon Rupture
- What is being tested?
- Early active motion training after operated FPL injury and Immobilisation in plaster cast 4 weeks after operated FPL injury
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 5 sitesSweden
- Study dates
- 1 May 2025to 31 Dec 2031
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and 2.
- Age over 15 years. Minors (<18 years) are considered to have sufficient maturity to understand the implications of the research.
- Swedish-speaking / able to understand spoken and written Swedish. Surgery performed within 14 days from the time of injury.
Who cannot join
- Tendon injury with a defect requiring tendon grafting. Another complete tendon injury in the same hand. Extensive associated injuries, such as fracture, vascular injury with circulatory impairment, large skin defect, or preoperative signs of infection. Patient deemed unsuitable for early active motion therapy due to factors such as lack of cooperation, cognitive impairment, or substance abuse issues.
- Patient declines follow-up in the HAKIR quality registry. Wound infection making early active motion therapy inappropriate.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Recruiting
Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus
Linköping
Erika Nyman, MD, Associate professor, +4610-105 96 90
erika.nyman@regionostergotland.se
- Recruiting
Handkirurgiska kliniken Örebros Universitetssjukhus
Örebro
Eva Lundqvist, MD, Phd, +196021000, eva.lundqvist@regionorebrolan.se+46+
- Recruiting
Handkirurgiska kliniken Södersjukhuset
Stockholm
Maria Wilcke, MD, Associate professor, +4681236022, maria.wilcke@ki.se
- Recruiting
Handkirurgiska kliniken Norrlands Universitetssjukhus
Umeå
Gustav Andersson, MD, Associate professor, +46907850000, gustav.andersson@regionvasterbotten.se
- Recruiting
Handkirugiska kliniken Uppsala Akademiska Sjukhus
Uppsala
Sara Edsfeldt, MD, Phd, +4618-6110000, sara.edsfeldt@akademiska.se
About this study
Official title: Registry-randomized Comparison of Rehabilitation Regimens After Flexor Pollicis Longus Injury in the Thumb
Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative rehabilitation is critical, specialized, and requires expertise from hand therapists. To prevent tendon adhesions and stiffness in the thumb or fingers, controlled active motion therapy is usually initiated within a few days after surgery. Studies on finger flexor tendon injuries have shown that early active movement therapy leads to better mobility compared to immobilization. Consequently, early active training is now the standard treatment following flexor tendon repair. However, during postoperative rehabilitation, the repaired flexor tendon may rupture, often necessitating revision surgery.
The rupture rate after flexor tendon repair in the thumb is approximately three times higher than in other fingers (10% vs. 3%). While most studies on flexor tendon injuries focus on finger tendons, research on the outcomes of thumb flexor tendon injuries is limited. The biomechanics and anatomy of the thumb's flexor tendon differ significantly from those of finger tendons.
Read more
The objective of this study is to determine whether the rupture rate following thumb flexor tendon surgery can be reduced by immobilizing the thumb in a cast for four weeks postoperatively, compared to standard early active motion therapy, without negatively affecting joint mobility and thumb strength. Additionally, the study will evaluate patient-reported outcomes one year post-surgery for both rehabilitation regimens (immobilization vs. mobilization).
This study is a registry-randomized clinical trial (RRCT) involving five hand surgery clinics in Sweden. Data following randomization between the two rehabilitation protocols will be collected through follow-up in the Swedish National Hand Surgery Quality Registry (HAKIR).
- Being tested
- Early active motion training after operated FPL injury, Immobilisation in plaster cast 4 weeks after operated FPL injury
- Keywords
- Flexor pollicis longus injury, RRCT, Early active motion, flexor tendon injury, Thumb, Immobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early active motion training after operated FPL injuryOther
Early active motion training after operated FPL injury
Immobilisation in plaster cast 4 weeks after operated FPL injuryOther
Immobilisation in plaster cast 4 weeks after operated FPL injury
| Study group | Role | What they receive |
|---|---|---|
| Early active motion | Active comparator | Early active motion 2-5 days postoperatively. Receives: Other: Early active motion training after operated FPL injury |
| Immobilisation in plaster cast 4 weeks | Active comparator | Immobilisation in plaster cast 4 weeks postoperatively Receives: Other: Immobilisation in plaster cast 4 weeks after operated FPL injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon rupture rate
Clinically diagnosed rupture of an operated flexor pollicis longus injury
Measured: Within one year after operation
Secondary outcomes (7)
Active range of motion in the joints of the operated thumb MCP joint
Active range of motion of the MCP joint of the operated thumb measured with a goniometer
Measured: 3 and 12 months postoperatively
Active range of motion of the IP-joint in the opererated thumb
Measured with a goniometer
Measured: 3 and 12 months postoperatively
Grip strength
Measured using a Jamar dynamometer and compared to the uninjured side.gauge.
Measured: 3 and 12 months postoperatively
Key pinch strength
Key pinch between the thumb and index finger assessed with a pinch gauge.
Measured: 3 and 12 months postoperatively
HQ-8 questionnaire
A Patient-rated outcome measurse (PROM).The HAKIR questionnaire (HQ-8) consists of seven questions regarding symptoms in the operated hand, such as aching, pain, numbness, weakness, and cold sensitivity, as well as one question on perceived hand function. All questions are answered on a 0-100 scale (0, 10, 20, etc.). An additional question in the questionnaire addresses satisfaction with the surgical outcome, rated from completely dissatisfied to completely satisfied.
Measured: 3 and 12 months postoperatively
Quick DASH
A patient-rated outcome measure (PROM). The short version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) contains 11 questions covering activity limitations, symptoms, and participation. The responses are summed into a total score ranging from 0 to 100, where 100 represents maximum perceived disability of the hand and arm.
Measured: 3 and 12 months postoperatively
Overall satisfaction with rehabilitation
Five-point Likert scale of overall satisfaction with rehabilitation: the five response options are: (1) Yes, to a very large extent, (2) Yes, to a large extent, (3) To a certain extent, (4) To a small extent, and (5) Not at all.
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 May 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (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.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Registry-randomized controlled trial (RRCT)
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Region Östergötland, Region Västerbotten, Region Örebro County, Uppsala County Council, Sweden
- Responsible party
- Principal investigator, Maria Wilcke, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836349
- Sponsor's protocol ID
- RRCT HAKIR fpl
- Status last verified
- May 2026
- First submitted
- 7 Feb 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data might be shared upon request for metaanalyses.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry-randomized Comparison of Rehabilitation Regimens After Flexor Pollicis Longus Injury in the Thumb
- ClinicalTrials.gov ID
- NCT06836349
- Acronym / sponsor ID
- RRCT HAKIR fpl
- Keywords
- Flexor pollicis longus injury, RRCT, Early active motion, flexor tendon injury, Thumb, Immobilisation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Region Östergötland, Region Västerbotten, Region Örebro County, Uppsala County Council, Sweden
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 20 Feb 2025 (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.
Flexor tendon injuries in the thumb occur across all ages and genders. Each year, approximately 400 patients undergo surgery for a flexor tendon injury in Sweden. These injuries are exclusively treated at one of the seven specialized hand surgery clinics, as the surgery is technically demanding, and postoperative rehabilitation is critical, specialized, and requires expertise from hand therapists. To prevent tendon adhesions and stiffness in the thumb or fingers, controlled active motion therapy is usually initiated within a few days after surgery. Studies on finger flexor tendon injuries have shown that early active movement therapy leads to better mobility compared to immobilization. Consequently, early active training is now the standard treatment following flexor tendon repair. However, during postoperative rehabilitation, the repaired flexor tendon may rupture, often necessitating revision surgery.
The rupture rate after flexor tendon repair in the thumb is approximately three times higher than in other fingers (10% vs. 3%). While most studies on flexor tendon injuries focus on finger tendons, research on the outcomes of thumb flexor tendon injuries is limited. The biomechanics and anatomy of the thumb's flexor tendon differ significantly from those of finger tendons.
The objective of this study is to determine whether the rupture rate following thumb flexor tendon surgery can be reduced by immobilizing the thumb in a cast for four weeks postoperatively, compared to standard early active motion therapy, without negatively affecting joint mobility and thumb strength. Additionally, the study will evaluate patient-reported outcomes one year post-surgery for both rehabilitation regimens (immobilization vs. mobilization).
This study is a registry-randomized clinical trial (RRCT) involving five hand surgery clinics in Sweden. Data following randomization between the two rehabilitation protocols will be collected through follow-up in the Swedish National Hand Surgery Quality Registry (HAKIR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Registry-randomized controlled trial (RRCT)
| Arm | Type | Receives |
|---|---|---|
| Early active motion | Active comparator | Other: Early active motion training after operated FPL injuryEarly active motion 2-5 days postoperatively. |
| Immobilisation in plaster cast 4 weeks | Active comparator | Other: Immobilisation in plaster cast 4 weeks after operated FPL injuryImmobilisation in plaster cast 4 weeks postoperatively |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and 2.
- Age over 15 years. Minors (<18 years) are considered to have sufficient maturity to understand the implications of the research.
- Swedish-speaking / able to understand spoken and written Swedish. Surgery performed within 14 days from the time of injury.
Key exclusion criteria (2 listed)
- Tendon injury with a defect requiring tendon grafting. Another complete tendon injury in the same hand. Extensive associated injuries, such as fracture, vascular injury with circulatory impairment, large skin defect, or preoperative signs of infection. Patient deemed unsuitable for early active motion therapy due to factors such as lack of cooperation, cognitive impairment, or substance abuse issues.
- Patient declines follow-up in the HAKIR quality registry. Wound infection making early active motion therapy inappropriate.
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 |
|---|---|---|
| Early active motion training after operated FPL injuryEarly active motion training after operated FPL injury | Other | Early active motion |
| Immobilisation in plaster cast 4 weeks after operated FPL injuryImmobilisation in plaster cast 4 weeks after operated FPL injury | Other | Immobilisation in plaster cast 4 weeks |
Primary outcome
Tendon rupture rate
Time frame: Within one year after operation
Clinically diagnosed rupture of an operated flexor pollicis longus injury
7 secondary outcomes
Active range of motion in the joints of the operated thumb MCP joint
Time frame: 3 and 12 months postoperatively
Active range of motion of the IP-joint in the opererated thumb
Time frame: 3 and 12 months postoperatively
Grip strength
Time frame: 3 and 12 months postoperatively
Key pinch strength
Time frame: 3 and 12 months postoperatively
HQ-8 questionnaire
Time frame: 3 and 12 months postoperatively
Quick DASH
Time frame: 3 and 12 months postoperatively
Overall satisfaction with rehabilitation
Time frame: 3 and 12 months
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 3 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified data might be shared upon request for metaanalyses.
Related trials for Flexor Tendon Injury
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Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
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Ultrasound-Guided Repeated Saline Injections to Prevent and Treat Tendon Adhesions After Hand Tendon Repair
Tendon Adhesion, Zone II Flexor Tendon Injury
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Virtual Reality Combined With Active Mobilization Post Flexor Tendon Repair
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Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair
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Not yet recruiting
Comparing Two Skin Incisions for Flexor Tendon Repair
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early active motion training after operated FPL injury and Immobilisation in plaster cast 4 weeks after operated FPL injury in people with Flexor Tendon Injury and Rehabilitation Program, run by Karolinska Institutet at 5 sites in Sweden.
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 3 inclusion and 2 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. 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?
Contact Maria Wilcke, MD, Associate professor (+46812362022, maria.wilcke@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tendon rupture rate (time frame: Within one year after operation). 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 3 Jun 2026.