Registry-randomized Comparison of Rehabilitation Regimens After Flexor Pollicis Longus Injury in the Thumb
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 380
- Locations
- 5
- Primary Endpoint
- Tendon rupture rate
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Complete laceration of the thumb flexor tendon (Flexor Pollicis Longus; FPL) within zone 1 and
- •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.
Arms & Interventions
Early active motion
Early active motion 2-5 days postoperatively.
Intervention: Early active motion training after operated FPL injury (Other)
Immobilisation in plaster cast 4 weeks
Immobilisation in plaster cast 4 weeks postoperatively
Intervention: Immobilisation in plaster cast 4 weeks after operated FPL injury (Other)
Outcomes
Primary Outcomes
Tendon rupture rate
Time Frame: Within one year after operation
Clinically diagnosed rupture of an operated flexor pollicis longus injury
Secondary Outcomes
- Quick DASH(3 and 12 months postoperatively)
- HQ-8 questionnaire(3 and 12 months postoperatively)
- Active range of motion in the joints of the operated thumb MCP joint(3 and 12 months postoperatively)
- Active range of motion of the IP-joint in the opererated thumb(3 and 12 months postoperatively)
- Grip strength(3 and 12 months postoperatively)
- Key pinch strength(3 and 12 months postoperatively)
- Overall satisfaction with rehabilitation(3 and 12 months)
Investigators
Maria Wilcke
Associate professor
Karolinska Institutet