- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868826
Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion
May 26, 2025 updated by: Jeppe Lange, Horsens Hospital
The aim of the study is to investigate pain, function and quality of life before and 10-12 months after surgical repair and/or rehabilitation of hamstrings avulsion
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Danmark
-
Horsens, Danmark, Denmark, DK-8700
- Signe Kierkegaard
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with hamstring avulsion
Description
Inclusion Criteria:
- Patients eligible for treatment of hamstring avulsion
Exclusion Criteria:
- Conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions
- Patients that do not speak or understand Danish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perth Hamstring Assessment Tool (PHAT) (0-100 scale)
Time Frame: Change from before surgery to 10-12 months after surgery on the 0-100 scale.
|
Overall tool and pain subscale during sitting, steps and relaxing separately extracted.
0 indicates total problems and 100 no problems.
|
Change from before surgery to 10-12 months after surgery on the 0-100 scale.
|
|
Knee flexion strength of affected leg (Newton meters per kilogram)
Time Frame: Change from before surgery to 10-12 months after surgery
|
Maximal knee flexion strength of affected leg expressed as newton meters per kilogram, measured with a handheld dynamometer
|
Change from before surgery to 10-12 months after surgery
|
|
Hip extension strength of affected leg (Newton meters per kilogram)
Time Frame: Change from before surgery to 10-12 months after surgery
|
Maximal hip extension strength of affected leg expressed as newton meters per kilogram, measured with a handheld dynamometer
|
Change from before surgery to 10-12 months after surgery
|
|
Overall health
Time Frame: Change from before surgery to 10-12 months after surgery on the 0-100 scale
|
0-100 continuous scale (0 worst imaginable health, 100 best imaginable health)
|
Change from before surgery to 10-12 months after surgery on the 0-100 scale
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee flexion strength of contralateral leg (Newton meters per kilogram)
Time Frame: Change from before surgery to 10-12 months after surgery
|
Maximal knee flexion strength of contralateral leg expressed as newton meters per kilogram, measured with a handheld dynamometer
|
Change from before surgery to 10-12 months after surgery
|
|
Hip extension strength of contralateral leg (Newton meters per kilogram)
Time Frame: Change from before surgery to 10-12 months after surgery
|
Maximal hip extension strength of contralateral leg expressed as newton meters per kilogram, measured with a handheld dynamometer
|
Change from before surgery to 10-12 months after surgery
|
|
Hip Sports Activity Scale (0-8 scale)
Time Frame: Change from before surgery to 10-12 months after surgery on the 0-8 scale
|
Type of activity before injury and present 0, no activity, 8 athlete level.
|
Change from before surgery to 10-12 months after surgery on the 0-8 scale
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 6, 2019
Primary Completion (Actual)
March 6, 2024
Study Completion (Actual)
October 6, 2024
Study Registration Dates
First Submitted
March 4, 2019
First Submitted That Met QC Criteria
March 8, 2019
First Posted (Actual)
March 11, 2019
Study Record Updates
Last Update Posted (Actual)
May 30, 2025
Last Update Submitted That Met QC Criteria
May 26, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 1-16-02-75-19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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