No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
15 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
380 (estimated)
Sponsor
Karolinska Institutet · Other
Who this trial is looking for
This trial is looking for people who have had a complete injury to the flexor tendon in their thumb. Participants will compare two different rehabilitation methods after surgery to see which one helps prevent further injuries.
Are You a Good Fit for This Trial?
You may be able to join if
I have a complete laceration of the thumb flexor tendon.
I am over 15 years old.
I speak and understand Swedish.
My surgery will be within 14 days from my injury.
You may not be able to join if
I need a tendon graft for my injury.
I have another complete tendon injury in the same hand.
I have extensive injuries like fractures or circulatory problems.
I cannot participate in active motion therapy due to personal issues.
I have a wound infection that prevents early therapy.
I do not want to follow up in the HAKIR quality registry.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.…
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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 …
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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