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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorKarolinska Institutet

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early active motion training after operated FPL injury

    Other intervention

    Early active motion training after operated FPL injury

  • Immobilisation in plaster cast 4 weeks after operated FPL injury

    Other intervention

    Immobilisation in plaster cast 4 weeks after operated FPL injury

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Early active motionActive comparator 1 intervention
Group B: Immobilisation in plaster cast 4 weeksActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tendon rupture rate

Clinically diagnosed rupture of an operated flexor pollicis longus injury

Time frame
Within one year after operation

Secondary outcomes

1

Active range of motion in the joints of the operated thumb MCP joint

Active range of motion of the MCP joint of the operated thumb measured with a goniometer

Time frame
3 and 12 months postoperatively
2

Active range of motion of the IP-joint in the opererated thumb

Measured with a goniometer

Time frame
3 and 12 months postoperatively
3

Grip strength

Measured using a Jamar dynamometer and compared to the uninjured side.gauge.

Time frame
3 and 12 months postoperatively
4

Key pinch strength

Key pinch between the thumb and index finger assessed with a pinch gauge.

Time frame
3 and 12 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator

Region Östergötland

Collaborator

Region Västerbotten

Collaborator

Region Örebro County

Collaborator

Uppsala County Council, Sweden

Collaborator