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

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

Interventions

OTHER

Early active motion training after operated FPL injury

Early active motion training after operated FPL injury

OTHER

Immobilisation in plaster cast 4 weeks after operated FPL injury

Immobilisation in plaster cast 4 weeks after operated FPL injury

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• Region Östergötland

  collaborator OTHER

• Region Västerbotten

  collaborator OTHER_GOV

• Region Örebro County

  collaborator OTHER

• Uppsala County Council, Sweden

  collaborator OTHER_GOV

• Karolinska Institutet

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2031-12-31

Completion

2031-12-31

Countries

• Sweden

Study Locations