Functional Outcome After EPL-rupture After Distal Radius Fracture

NCT05264675 | Recruiting

• 1 other identifier: VGFOUGSB-964048
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Rupture of the extensor pollicis longus, (EPL) is a common complication after distal radius fractures. A rupture prevents the thumb extension, which in turn has a negative impact on hand function. An EPL-rupture can either be surgically treated by primary suture, which means that the ends of the tendon are sutured. This is however not recommended if the tendon is weakened. In such cases the rupture can be treated by a transfer of, most often, extensor indicis proprius (EIP) to the thumb. Distal radius fractures are common and a rupture of the EPL-tendon is a known complication thar interferes with hand function and therefore more studies on this patient group are warranted. The aim of this prospective study is to compare regaining of thumb function after surgery, with the non-injured side, after primary suture and EIP-transfer after EPL-rupture as a complication following distal radius fracture.

Conditions

Distal Radius Fracture

Keywords

EPL-rupture; Distal radius fracture; Function; ADL

Outcome Measures

Primary Outcomes (2)

• range of motion

  extension, flexion, abduction, retroposition of thumb

  3 months postoperatively

• range of motion

  extension, flexion, abduction, retroposition of thumb

  6 months postoperatively

Secondary Outcomes (2)

• strength

  3 months postoperatively

• strength

  6 months postoperatively

Other Outcomes (2)

• Quick-DASH (Disabilities of the Arm, Shoulder and Hand)

  3 months postoperatively

• Quick-DASH (Disabilities of the Arm, Shoulder and Hand)

  6 months postoperatively

Study Arms (2)

Primary suture

primary suture of EPL

Procedure: primary suture

EIP- transfer

transfer of the EIP to EPL

Procedure: EIP-transfer

Interventions

primary suture PROCEDURE

Primary suture of the EPL-tendon

Primary suture

EIP-transfer PROCEDURE

transfer of the EIP-tendon to the EPL-tendon

EIP- transfer

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with distal radius fractures who suffer from rupture of the EPL-tendon

You may qualify if:

• Distal Radius Fracture
• EPL-rupture

You may not qualify if:

• comorbidity interfering with thumb function
• inability to fill in forms

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, 43130, Sweden

RECRUITING

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Ingrid Andreasson, Md Dr

  Sahlgrenska Universitetssjukhuset

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Andreasson, Md Dr

CONTACT

+46 31 343 10 36; ingrid.f.andreasson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2022
• First Posted: March 3, 2022
• Study Start: January 1, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)