Hamstring InjuryNCT03868826
Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion
An observational study of Hamstring Injury, run by Horsens Hospital at 1 site in Denmark.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hamstring Injury
- What is being tested?
- Orthopaedic surgery and/or rehabilitation
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Mar 2019to 6 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with hamstring avulsion
Who may be able to join
- Patients eligible for treatment of hamstring avulsion
Who cannot join
- Conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions
- Patients that do not speak or understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Hamstring Injury
- Being tested
- Orthopaedic surgery and/or rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic surgery and/or rehabilitationProcedure or surgery
The avulsion is repaired and hereafter the patient follows rehabilitation. Some are treated conservatively and only follow rehabilitation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perth Hamstring Assessment Tool (PHAT) (0-100 scale)
Overall tool and pain subscale during sitting, steps and relaxing separately extracted. 0 indicates total problems and 100 no problems.
Measured: 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)
Maximal knee flexion strength of affected leg expressed as newton meters per kilogram, measured with a handheld dynamometer
Measured: Change from before surgery to 10-12 months after surgery
Hip extension strength of affected leg (Newton meters per kilogram)
Maximal hip extension strength of affected leg expressed as newton meters per kilogram, measured with a handheld dynamometer
Measured: Change from before surgery to 10-12 months after surgery
Overall health
0-100 continuous scale (0 worst imaginable health, 100 best imaginable health)
Measured: Change from before surgery to 10-12 months after surgery on the 0-100 scale
Secondary outcomes (3)
Knee flexion strength of contralateral leg (Newton meters per kilogram)
Maximal knee flexion strength of contralateral leg expressed as newton meters per kilogram, measured with a handheld dynamometer
Measured: Change from before surgery to 10-12 months after surgery
Hip extension strength of contralateral leg (Newton meters per kilogram)
Maximal hip extension strength of contralateral leg expressed as newton meters per kilogram, measured with a handheld dynamometer
Measured: Change from before surgery to 10-12 months after surgery
Hip Sports Activity Scale (0-8 scale)
Type of activity before injury and present 0, no activity, 8 athlete level.
Measured: Change from before surgery to 10-12 months after surgery on the 0-8 scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start6 Mar 2019
- Primary completion6 Mar 2024
- Study completion6 Oct 2024
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 Hamstring InjuryStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horsens Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeppe Lange, Horsens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868826
- Sponsor's protocol ID
- 1-16-02-75-19
- Status last verified
- May 2025
- First submitted
- 4 Mar 2019
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Spoorendonk K, Bohn MB, Storm JO, Lund B, Kierkegaard-Brochner S. Proximal Hamstring Avulsions: Surgical Versus Conservative Treatment Using a Shared Decision-Making Strategy. Orthop J Sports Med. 2024 Oct 21;12(10):23259671241275656. doi: 10.1177/23259671241275656. eCollection 2024 Oct.
PubMed 39440155
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion
- ClinicalTrials.gov ID
- NCT03868826
- Acronym / sponsor ID
- 1-16-02-75-19
- Conditions
- Hamstring Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Horsens HospitalUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Oct 2024 (actual)
- First posted
- 11 Mar 2019 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with hamstring avulsion
Key inclusion criteria (1 listed)
- Patients eligible for treatment of hamstring avulsion
Key exclusion criteria (2 listed)
- Conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions
- Patients that do not speak or understand Danish
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 |
|---|---|---|
| Orthopaedic surgery and/or rehabilitationThe avulsion is repaired and hereafter the patient follows rehabilitation. Some are treated conservatively and only follow rehabilitation. | Procedure or surgery | – |
Primary outcome
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.
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
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
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)
3 secondary outcomes
Knee flexion strength of contralateral leg (Newton meters per kilogram)
Time frame: 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
Hip Sports Activity Scale (0-8 scale)
Time frame: Change from before surgery to 10-12 months after surgery on the 0-8 scale
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 30 May 2025.
- Results publication: PubMed 39440155Spoorendonk K, Bohn MB, Storm JO, Lund B, Kierkegaard-Brochner S. Proximal Hamstring Avulsions: Surgical Versus Conservative Treatment Using a Shared Decision-Making Strategy. Orthop J Sports Med. 2024 Oct 21;12(10):23259671241275656. doi: 10.1177/23259671241275656. eCollection 2024 Oct.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Hamstring Injury, run by Horsens Hospital at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 30 May 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 Denmark. 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?
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.). The study lists 4 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 NCT03868826, 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 30 May 2025.