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

Not Applicable

Not yet recruiting

• Conditions: Flexor Tendon Injury; Flexor Tendon Rupture; Rehabilitation Program; Thumb Injury

• Registration Number: NCT06836349
• Lead Sponsor: Karolinska Institutet

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-04-01
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 380

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tendon rupture rate	Within one year after operation	Clinically diagnosed rupture of an operated flexor pollicis longus injury

Secondary Outcome Measures

Name	Time	Method
Active range of motion in the joints of the operated thumb MCP joint	3 and 12 months postoperatively	Active range of motion of the MCP joint of the operated thumb measured with a goniometer
Active range of motion of the IP-joint in the opererated thumb	3 and 12 months postoperatively	Measured with a goniometer
Grip strength	3 and 12 months postoperatively	Measured using a Jamar dynamometer and compared to the uninjured side.gauge.
Key pinch strength	3 and 12 months postoperatively	Key pinch between the thumb and index finger assessed with a pinch gauge.
HQ-8 questionnaire	3 and 12 months postoperatively	A Patient-rated outcpme measurs (PROM).The HAKIR questionnaire (HQ-8) consists of seven questions regarding symptoms in the operated hand, such as aching, pain, numbness, weakness, and cold sensitivity, as well as one question on perceived hand function. All questions are answered on a 0-100 scale (0, 10, 20, etc.). An additional question in the questionnaire addresses satisfaction with the surgical outcome and the experience of staff interactions during the given care, rated from completely dissatisfied to completely satisfied.
Quick DASH	3 and 12 months postoperatively	A patient-rated outcpme measure. (PROM. The short version of the Disabilities of the Arm, Shoulder, and Hand (QuickDASH) contains 11 questions covering activity limitations, symptoms, and participation. The responses are summed into a total score ranging from 0 to 100, where 100 represents maximum perceived disability of the hand and arm.

Trial Locations

Locations (5)

Hand- och plastikkirurgiska kliniken Linköpings Universitetssjukhus; 🇸🇪 Linköping, Sweden

Handkirurgiska kliniken Södersjukhuset; 🇸🇪 Stockholm, Sweden

Handkirurgiska kliniken Norrlands Universitetssjukhus; 🇸🇪 Umeå, Sweden

Handkirugiska kliniken Uppsala Akademiska Sjukhus; 🇸🇪 Uppsala, Sweden

Handkirurgiska kliniken Örebros Universitetssjukhus; 🇸🇪 Örebro, Sweden