Actively Recruiting
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
Led by Karolinska Institutet · Updated on 2025-06-03
380
Participants Needed
5
Research Sites
347 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus
Linköping, Sweden
Actively Recruiting
2
Handkirurgiska kliniken Örebros Universitetssjukhus
Örebro, Sweden
Actively Recruiting
3
Handkirurgiska kliniken Södersjukhuset
Stockholm, Sweden
Actively Recruiting
4
Handkirurgiska kliniken Norrlands Universitetssjukhus
Umeå, Sweden
Actively Recruiting
5
Handkirugiska kliniken Uppsala Akademiska Sjukhus
Uppsala, Sweden
Actively Recruiting
Research Team
M
Maria Wilcke, MD, Associate professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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