Functional Outcome After EPL-rupture After Distal Radius Fracture
NCT ID: NCT05264675
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
60 participants
OBSERVATIONAL
2022-01-01
2026-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rupture of Thumb's Long Extensor Tendon After Fracture of the Distal Radius, Study of Muscle and Tendon Pathology
NCT06313489
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
NCT06046404
Early Mobilization After Volar Plate Osteosynthesis of Distal Radius Fractures
NCT01576224
Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
NCT04554472
Volar Plating or External Fixation of Dorsally Displaced Fractures of the Distal Radius?
NCT00989222
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Primary suture
primary suture of EPL
primary suture
Primary suture of the EPL-tendon
EIP- transfer
transfer of the EIP to EPL
EIP-transfer
transfer of the EIP-tendon to the EPL-tendon
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
primary suture
Primary suture of the EPL-tendon
EIP-transfer
transfer of the EIP-tendon to the EPL-tendon
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* EPL-rupture
Exclusion Criteria
* inability to fill in forms
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vastra Gotaland Region
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ingrid Andreasson, Md Dr
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska Universitetssjukhuset
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sahlgrenska University Hospital
Mölndal, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Maria Stenvall
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VGFOUGSB-964048
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.