Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology

NCT06313489 | Completed

• 1 other identifier: 282151
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Fractures of the wrist (fractures of the distal radius) are one of the most common fractures with almost 60 000 injuries per year in Sweden. One known complication following these fractures is that the long extensor tendon of the thumb ruptures (extensor pollicis longus tendon, EPL tendon). This leads to disability to stretch the thumb in order to grip bigger objects. Earlier studies show that the tendon ruptures in about 3-5% of all wrist fractures. These ruptures occur some weeks to months after the fracture. There are different theories about the cause of the rupture. One theory is that the fracture creates a bleeding in the tight area that the tendon lies, leading to high pressure and therefore low blood supply to the tendon. Another theory is that the tendon comes in contact with some sharp bonny fragments in this area that injures the tendon when it moves. Such tendon ruptures need almost always some type of surgical intervention in order to reconstruct the function of the thumb. A common problem is that the quality of the tendon is insufficient for just suturing it. Another problem is that the muscle becomes stiff after the rupture. However, there is no objective method to determine how stiff the muscle is. The most common treatment option is the transfer of one of the two extensor tendons of the index finger to the thumb, a so-called extensor indicis proprius to extensor pollicis longus transfer. The motivation behind this operation is that the muscle of EPL is so stiff that cannot be used to lift the thumb. However, there is no consensus about the time period after which the EPL muscle can be used to reconstruct the function of thumb. The study aims to investigate the microscopical changes in the muscle and tendon of EPL after such a rupture. Better knowledge of these factors could lead to better understanding of the treatment options. The investigators plan to include in the study all patients that would get operated for an EPL tendon rupture after a fracture of the distal radius at the institution the study is conducted. After oral and written information to the patient and written consent the investigators will take some samples from the ruptured tendon and muscle for microscopical analysis.

Conditions

Distal Radius Fractures; Tendon Injury - Hand; Pathology

Keywords

Extensor pollicis longus rupture

Outcome Measures

Primary Outcomes (1)

• Histopathological analysis of the EPL muscle

  Histochemical analyses, Muscle fiber typing,immunostainings brightfield microscopy. Selected specimens were also immuno-stained with inflammatory cell markers

  Analysis within 8 weeks from sampling

Secondary Outcomes (1)

• Histopathological analysis of the EPL tendon

  Analysis within 8 weeks from sampling

Study Arms (1)

Patients with ruptures of Extensor pollicis longus tendon after distal radial fracture

Patients planned for intervention according to the clinical practice. We planned to include all patients that would be treated in out department.

Procedure: Biopsy of EPL tendon and muscle during the operation

Interventions

Biopsy of EPL tendon and muscle during the operation PROCEDURE

Biopsy of EPL tendon and muscle

Patients with ruptures of Extensor pollicis longus tendon after distal radial fracture

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with rupture of EPL after fractures of the distal radius at Sahlgrenska University Hospital at the department of Orthopaedic Traumatology and at the department of Hand surgery. The patients should be eligible for surgical reconstruction of EPL according to the clinical practise. Sahlgrenska University Hospital covers the metropolitan area of Gothenburg with a population of 1 million. Furthermore Sahlgrenska University Hospital is referral hospital for the greater region covering a population of about 2 millions.

You may qualify if:

• a clinically diagnosed EPL rupture after a fracture of the distal radius

You may not qualify if:

• Inability to read and understand Swedish
• Mental illness leading to inability to understand the study procedure or rehabilitation training.
• Active drug use.

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 43180, Sweden

Location

Related Publications (1)

• Sarigiannis CN, Ullman M, Andreasson I, Oldfors A, Bjorkman A. Inflammatory and degenerative changes in the extensor pollicis longus muscle and tendon following ruptures caused by distal radius fractures. BMC Musculoskelet Disord. 2025 Jan 3;26(1):10. doi: 10.1186/s12891-024-08212-4.

  PMID: 39754134 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens of EPL muscle and tendon in cases of tendon rupture after fractures of the distal radius

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Anders Björkman, Prof.

  Sahlgrenska University Hospital, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: February 1, 2023
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)