Actively Recruiting

Age: 16Years +
All Genders
ID05264675

Functional Outcome After Suture or EIP-transfer in EPL-rupture After Distal Radius Fracture

Led by Vastra Gotaland Region · Updated on 2024-11-14

60

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Rupture of the extensor pollicis longus (EPL) tendon is a common complication following distal radius fractures, affecting the ability to extend the thumb and impairing hand function. This research aims to compare how well patients regain thumb function after surgery, specifically between two surgical treatments: primary suture and transfer of the extensor indicis proprius (EIP) tendon. The study is prospective and focuses on patients who have experienced EPL rupture as a complication of distal radius fracture. The study evaluates two surgical methods for repairing the EPL tendon rupture. One group receives primary suture, where the torn ends of the tendon are stitched together, while the other group undergoes an EIP tendon transfer to restore thumb extension. After surgery, patients are immobilized with a cast (4 weeks for primary suture, 2 weeks for tendon transfer) followed by a specific thumb mobility exercise program using a static splint. Free mobilization and increased activity load are allowed six weeks after surgery, with no load restrictions after twelve weeks. Participants will be monitored through data collection at three and six months after surgery. Researchers will assess range of motion and strength of the thumb by comparing the injured hand to the non-injured side. Outcome measures include both objective tests and patient-reported function. The study also tracks recovery progress through grip and pinch strength tests and evaluates differences between the two surgical groups. The total participation time includes follow-up visits up to six months postoperatively to ensure safety and functional recovery.

CONDITIONS

Brief Title

Functional Outcome After EPL-rupture After Distal Radius Fracture

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Distal Radius Fracture
  • EPL-rupture
  • Age 16 years or older
Not Eligible

You will not qualify if you...

  • Comorbidity interfering with thumb function
  • Inability to fill in forms

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants undergo surgery for EPL tendon rupture either by primary suture or EIP transfer, followed by cast immobilization and a specific exercise program for thumb mobility.

1 surgery visit and multiple rehabilitation visits over 12 weeks

Follow-up

Duration - Up to 6 months postoperatively

Participants are assessed for thumb function recovery including range of motion and strength at 3 and 6 months after surgery.

2 visits (at 3 and 6 months postoperatively)

Trial Site Locations

Total: 1 location

1

Sahlgrenska University Hospital

Mölndal, Sweden, 43130

Actively Recruiting

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Research Team

I

Ingrid Andreasson, Md Dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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