Registry-randomized Comparison of Rehabilitation Regimens After Flexor Tendon Injury in the Thumb

NCT06836349 | Recruiting

• 1 other identifier: RRCT HAKIR fpl
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 5

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).

Conditions

Flexor Tendon Injury; Rehabilitation Program; Flexor Tendon Rupture; Thumb Injury

Keywords

Flexor pollicis longus injury; RRCT; Early active motion; flexor tendon injury; Thumb; Immobilisation

Outcome Measures

Primary Outcomes (1)

• Tendon rupture rate

  Clinically diagnosed rupture of an operated flexor pollicis longus injury

  Within one year after operation

Secondary Outcomes (6)

• 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

• HQ-8 questionnaire

  3 and 12 months postoperatively

Study Arms (2)

Early active motion

ACTIVE COMPARATOR

Early active motion 2-5 days postoperatively.

Other: Early active motion training after operated FPL injury

Immobilisation in plaster cast 4 weeks

ACTIVE COMPARATOR

Immobilisation in plaster cast 4 weeks postoperatively

Other: Immobilisation in plaster cast 4 weeks after operated FPL injury

Interventions

Early active motion training after operated FPL injury OTHER

Early active motion training after operated FPL injury

Early active motion

Immobilisation in plaster cast 4 weeks after operated FPL injury OTHER

Immobilisation in plaster cast 4 weeks after operated FPL injury

Immobilisation in plaster cast 4 weeks

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Region Östergötland: collaborator
• Region Västerbotten: collaborator
• Region Örebro County: collaborator
• Uppsala County Council, Sweden: collaborator

Study Sites (5)

Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus

Linköping, Sweden

RECRUITING

Handkirurgiska kliniken Örebros Universitetssjukhus

Örebro, Sweden

RECRUITING

Handkirurgiska kliniken Södersjukhuset

Stockholm, Sweden

RECRUITING

Handkirurgiska kliniken Norrlands Universitetssjukhus

Umeå, Sweden

RECRUITING

Handkirugiska kliniken Uppsala Akademiska Sjukhus

Uppsala, Sweden

RECRUITING

MeSH Terms

Interventions

Immobilization; Casts, Surgical

Intervention Hierarchy (Ancestors)

Investigative Techniques; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Central Study Contacts

Maria Wilcke, MD, Associate professor

CONTACT

+46812362022; maria.wilcke@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Registry-randomized controlled trial (RRCT)

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 20, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the results are analyzed and publish and 10 years ahead
• Access Criteria: Researchers with an ethical permitt, as descibed above, by request to maria.wilcke@ki.se

Locations

SE (5)