Distal Radius FracturesNCT06313489
Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology
An observational study of Distal Radius Fractures and Tendon Injury - Hand, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Distal Radius Fractures, Tendon Injury - Hand, Pathology
- What is being tested?
- Biopsy of EPL tendon and muscle during the operation
- Type of treatment
- Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 3 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- a clinically diagnosed EPL rupture after a fracture of the distal radius
Who cannot join
- Inability to read and understand Swedish
- Mental illness leading to inability to understand the study procedure or rehabilitation training.
- Active drug use.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 43180
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Distal Radius Fractures, Tendon Injury - Hand, Pathology
- Being tested
- Biopsy of EPL tendon and muscle during the operation
- Keywords
- Extensor pollicis longus rupture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of EPL tendon and muscle during the operationProcedure or surgery
Biopsy of EPL tendon and muscle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biopsy of EPL tendon and muscle during the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histopathological analysis of the EPL muscle
Histochemical analyses, Muscle fiber typing,immunostainings brightfield microscopy. Selected specimens were also immuno-stained with inflammatory cell markers
Measured: Analysis within 8 weeks from sampling
Secondary outcomes (1)
Histopathological analysis of the EPL tendon
immunostainings brightfield microscopy
Measured: Analysis within 8 weeks from sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Feb 2023
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Bjorkman, Göteborg University
- Investigators
- Anders Björkman, Prof., Principal investigator, Sahlgrenska University Hospital, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313489
- Sponsor's protocol ID
- 282151
- Status last verified
- Jan 2025
- First submitted
- 7 Mar 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39754134
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rupture of Extensor Pollicis Longus Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology
- ClinicalTrials.gov ID
- NCT06313489
- Acronym / sponsor ID
- 282151
- Conditions
- Distal Radius Fractures, Tendon Injury - Hand, Pathology
- Keywords
- Extensor pollicis longus rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ruptures of Extensor pollicis longus tendon after distal radial fracture | – | Procedure: Biopsy of EPL tendon and muscle during the operationPatients planned for intervention according to the clinical practice. We planned to include all patients that would be treated in out department. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- a clinically diagnosed EPL rupture after a fracture of the distal radius
Key exclusion criteria (3 listed)
- Inability to read and understand Swedish
- Mental illness leading to inability to understand the study procedure or rehabilitation training.
- Active drug use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy of EPL tendon and muscle during the operationBiopsy of EPL tendon and muscle | Procedure or surgery | Patients with ruptures of Extensor pollicis longus tendon after distal radial fracture |
Primary outcome
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
1 secondary outcome
Histopathological analysis of the EPL tendon
Time frame: Analysis within 8 weeks from sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 39754134Sarigiannis 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.
- Individual participant dataSharing planned: No
Related trials for Distal Radius Fractures
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Björkman, Prof. principal investigator
Sahlgrenska University Hospital, University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fractures and Tendon Injury - Hand, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histopathological analysis of the EPL muscle (time frame: Analysis within 8 weeks from sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.