- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06313489
Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology
Rupture of Extensor Pollicis Longus Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ruptures of extensor pollicis longus (EPL) tendon are a known complication of fractures of the distal radius. The study plan is to conduct a prospective histopathological study of the EPL muscle and tendon on patients operated for ruptures of EPL after fractures of the distal radius.
The standard treatment at the institution the study is conducted is a tendon transfer of extensor indicis proprius to EPL. Under this operation the investigators plan to take tissue biopsies from the distal part of the muscle and the ruptured tendon and conduct a histopathological analysis.
Participants received oral and written information and left a written consent. The participants were assessed for sex, age, relevant medication and prior surgical interventions in the hand and wrist. Epidemiological data for the fracture time, classification and treatment is documented as well epidemiological data for the tendon rupture.
The histopathological analysis is conducted by one researcher in the group, expert in muscle pathology.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Västra Götaland
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Gothenburg, Västra Götaland, Sweden, 43180
- Sahlgrenska University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- a clinically diagnosed EPL rupture after a fracture of the distal radius
Exclusion Criteria:
- Inability to read and understand Swedish
- Mental illness leading to inability to understand the study procedure or rehabilitation training.
- Active drug use.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Biopsy of EPL tendon and muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histopathological analysis of the EPL muscle
Time Frame: Analysis within 8 weeks from sampling
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histopathological analysis of the EPL tendon
Time Frame: Analysis within 8 weeks from sampling
|
immunostainings brightfield microscopy
|
Analysis within 8 weeks from sampling
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anders Björkman, Prof., Sahlgrenska University Hospital, University of Gothenburg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 282151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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