Distal Radius FractureNCT05264675
Functional Outcome After EPL-rupture After Distal Radius Fracture
An observational study of Distal Radius Fracture, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- primary suture and EIP-transfer
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with distal radius fractures who suffer from rupture of the EPL-tendon
Who may be able to join
- Distal Radius Fracture
- EPL-rupture
Who cannot join
- comorbidity interfering with thumb function
- inability to fill in forms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Mölndal, 43130
Ingrid Andreasson, +46313431036, ingrid.f.andreasson@vgregion.se
Maria Stenvall, +46313431036
About this study
Official title: Functional Outcome After Suture or EIP-transfer in EPL-rupture After Distal Radius Fracture
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.
Read the detailed description
Rupture of the long extensor tendon of the thumb (extensor pollicis longus, EPL) is a common complication after distal radius fracture. The incidence has been shown to be about 1% after surgical treatment of the fracture and up to 5% after non-surgical treatment.
The reason why the tendon ruptures after minimally displaced fractures may be reduced blood flow to the tendon. After surgical treatment of a fracture, the cause of rupture may be irritation of the tendon caused by the osteosynthesis material. A rupture means that the thumb cannot be extended, which affects the function of the hand negatively.
EPL rupture can either be operated with primary suture, which means that the ends of the tendon are found and sutured, however this is not recommended if the tendon is weakened, for example due to poor vascularisation. In such a case, the EPL rupture can be repaired by moving a tendon, (usually the extensor indicis proprius, EIP), to the thumb .
Previous studies focusing on function after EPL rupture have been small and have not differentiated EPL ruptures with different underlying causes and the regimen of post-operative care has not been uniform.
Since distal radius fracture is a very common injury and rupture of the EPL tendon is a known complication that affects hand function, it is important that more studies are done on this patient group. Function should be evaluated both with objective and patient-related outcome measures. Knowledge of function after surgery is important for patients, surgeons and rehabilitation staff.
Purpose
The purpose of the present prospective study is to compare recovery of thumb function relative to the non-injured side after primary suture and EIP transfer respectively in rupture of the EPL after distal radius fracture.
Questions
How do patients rate their function after primary suture or EIP transfer?
How much recovery of thumb function occurs relative to the non-injured hand?
Do the groups differ in these respects?
Intervention
After primary suture/tendon transfer and cast immobilization (4 weeks after primary suture and 2 weeks after tendon transfer, respectively), patients will begin exercise according to a specific exercise program for thumb mobility. Between training sessions, an individually adapted, static splint is used with the thumb in extension (2 weeks after primary suture and 4 weeks after tendon transfer, respectively).
Six weeks postoperatively, free mobilization is allowed in light activities of daily living with progressively increased load and training according to the program continues.After twelve weeks, the patient has no restrictions regarding load.
Data collection will take place at 3 and 6 months postoperatively,
The grouping will be based on the treatment method chosen by the surgeon as this is related to the nature of the injury.
Power calculation
A power calculation was made based on the assumption that the group has a mean QuickDASH score of 25 points (SD 8) preoperatively and that the difference between the groups would be 6.8 points, which corresponds to "minimal clinically important difference". To reach a power of 0.80 with alpha 0.05, 22 patients per group are needed. To compensate for a presumed dropout, 30 patients per group are planned to be included.
The patients will be selected via the planning system for operations. The inclusion is expected to last for up to two years.
Data processing
Grip and pinch strength and mobility will be calculated as a percentage of the non-injured side and an average of the percentage will be calculated. Any statistical difference between operated and non-operated side and between the groups will be calculated with t-test.
Expected result / Clinical significance
The expected result is that the patients regain a large part of their function, which is of great importance for the individual patient, no difference between the groups is expected to emerge.
The study is expected to confirm that the treatment regimens used work well, which is important as Sahlgrenska University Hospital strives to use evidence-based treatment methods.
- Conditions
- Distal Radius Fracture
- Being tested
- primary suture, EIP-transfer
- Keywords
- EPL-rupture, Distal radius fracture, Function, ADL
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary sutureProcedure or surgery
Primary suture of the EPL-tendon
EIP-transferProcedure or surgery
transfer of the EIP-tendon to the EPL-tendon
| Study group | Role | What they receive |
|---|---|---|
| Primary suture | primary suture of EPL Receives: Procedure: primary suture | |
| EIP- transfer | transfer of the EIP to EPL Receives: Procedure: EIP-transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
extension, flexion, abduction, retroposition of thumb
Measured: 3 months postoperatively
range of motion
extension, flexion, abduction, retroposition of thumb
Measured: 6 months postoperatively
Secondary outcomes (2)
strength
pinch, lateral pinch, grip strength
Measured: 3 months postoperatively
strength
pinch, lateral pinch, grip strength
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Jan 2022
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 FractureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ingrid Andreasson, Md Dr, Principal investigator, Sahlgrenska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264675
- Sponsor's protocol ID
- VGFOUGSB-964048
- Status last verified
- Nov 2024
- First submitted
- 18 Feb 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreasson I, Sarigiannis CN, Ullman M, Bjorkman A. Functional results after extensor indicis proprius to extensor pollicis longus tendon transfer for ruptures associated with distal radius fractures. J Plast Surg Hand Surg. 2026 May 26;61:140-145. doi: 10.2340/jphs.v61.46150.
PubMed 42187295
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome After Suture or EIP-transfer in EPL-rupture After Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT05264675
- Acronym / sponsor ID
- VGFOUGSB-964048
- Conditions
- Distal Radius Fracture
- Keywords
- EPL-rupture, Distal radius fracture, Function, ADL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Mar 2022 (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.
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.
Detailed description
Rupture of the long extensor tendon of the thumb (extensor pollicis longus, EPL) is a common complication after distal radius fracture. The incidence has been shown to be about 1% after surgical treatment of the fracture and up to 5% after non-surgical treatment.
The reason why the tendon ruptures after minimally displaced fractures may be reduced blood flow to the tendon. After surgical treatment of a fracture, the cause of rupture may be irritation of the tendon caused by the osteosynthesis material. A rupture means that the thumb cannot be extended, which affects the function of the hand negatively.
EPL rupture can either be operated with primary suture, which means that the ends of the tendon are found and sutured, however this is not recommended if the tendon is weakened, for example due to poor vascularisation. In such a case, the EPL rupture can be repaired by moving a tendon, (usually the extensor indicis proprius, EIP), to the thumb .
Previous studies focusing on function after EPL rupture have been small and have not differentiated EPL ruptures with different underlying causes and the regimen of post-operative care has not been uniform.
Since distal radius fracture is a very common injury and rupture of the EPL tendon is a known complication that affects hand function, it is important that more studies are done on this patient group. Function should be evaluated both with objective and patient-related outcome measures. Knowledge of function after surgery is important for patients, surgeons and rehabilitation staff.
Purpose
The purpose of the present prospective study is to compare recovery of thumb function relative to the non-injured side after primary suture and EIP transfer respectively in rupture of the EPL after distal radius fracture.
Questions
How do patients rate their function after primary suture or EIP transfer?
How much recovery of thumb function occurs relative to the non-injured hand?
Do the groups differ in these respects?
Intervention
After primary suture/tendon transfer and cast immobilization (4 weeks after primary suture and 2 weeks after tendon transfer, respectively), patients will begin exercise according to a specific exercise program for thumb mobility. Between training sessions, an individually adapted, static splint is used with the thumb in extension (2 weeks after primary suture and 4 weeks after tendon transfer, respectively).
Six weeks postoperatively, free mobilization is allowed in light activities of daily living with progressively increased load and training according to the program continues.After twelve weeks, the patient has no restrictions regarding load.
Data collection will take place at 3 and 6 months postoperatively,
The grouping will be based on the treatment method chosen by the surgeon as this is related to the nature of the injury.
Power calculation
A power calculation was made based on the assumption that the group has a mean QuickDASH score of 25 points (SD 8) preoperatively and that the difference between the groups would be 6.8 points, which corresponds to "minimal clinically important difference". To reach a power of 0.80 with alpha 0.05, 22 patients per group are needed. To compensate for a presumed dropout, 30 patients per group are planned to be included.
The patients will be selected via the planning system for operations. The inclusion is expected to last for up to two years.
Data processing
Grip and pinch strength and mobility will be calculated as a percentage of the non-injured side and an average of the percentage will be calculated. Any statistical difference between operated and non-operated side and between the groups will be calculated with t-test.
Expected result / Clinical significance
The expected result is that the patients regain a large part of their function, which is of great importance for the individual patient, no difference between the groups is expected to emerge.
The study is expected to confirm that the treatment regimens used work well, which is important as Sahlgrenska University Hospital strives to use evidence-based treatment methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary suture | – | Procedure: primary sutureprimary suture of EPL |
| EIP- transfer | – | Procedure: EIP-transfertransfer of the EIP to EPL |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with distal radius fractures who suffer from rupture of the EPL-tendon
Key inclusion criteria (2 listed)
- Distal Radius Fracture
- EPL-rupture
Key exclusion criteria (2 listed)
- comorbidity interfering with thumb function
- inability to fill in forms
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 |
|---|---|---|
| primary suturePrimary suture of the EPL-tendon | Procedure or surgery | Primary suture |
| EIP-transfertransfer of the EIP-tendon to the EPL-tendon | Procedure or surgery | EIP- transfer |
Primary outcome
range of motion
Time frame: 3 months postoperatively
extension, flexion, abduction, retroposition of thumb
range of motion
Time frame: 6 months postoperatively
extension, flexion, abduction, retroposition of thumb
2 secondary outcomes
strength
Time frame: 3 months postoperatively
strength
Time frame: 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Derived from this study: PubMed 42187295Andreasson I, Sarigiannis CN, Ullman M, Bjorkman A. Functional results after extensor indicis proprius to extensor pollicis longus tendon transfer for ruptures associated with distal radius fractures. J Plast Surg Hand Surg. 2026 May 26;61:140-145. doi: 10.2340/jphs.v61.46150.
- Individual participant dataSharing planned: No
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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.
Ingrid Andreasson, Md Dr principal investigator
Sahlgrenska Universitetssjukhuset
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 Fracture, run by Vastra Gotaland Region 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Andreasson, Md Dr (+46 31 343 10 36, ingrid.f.andreasson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (time frame: 3 months postoperatively). The study lists 2 primary outcomes in all. 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 NCT05264675, 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 14 Nov 2024.