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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03868826
Other study ID # 1-16-02-75-19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 6, 2019
Est. completion date March 6, 2025

Study information

Verified date July 2021
Source Horsens Hospital
Contact Signe Kierkegaard, PhD
Phone +45 7842 5000
Email signkier@rm.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 6, 2025
Est. primary completion date March 6, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Orthopaedic surgery and/or rehabilitation
The avulsion is repaired and hereafter the patient follows rehabilitation. Some are treated conservatively and only follow rehabilitation.

Locations

Country Name City State
Denmark Signe Kierkegaard Horsens Danmark

Sponsors (1)

Lead Sponsor Collaborator
Horsens Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from before surgery to 10-12 months after surgery on the 0-100 scale.
Primary 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 Change from before surgery to 10-12 months after surgery
Primary 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 Change from before surgery to 10-12 months after surgery
Primary Overall health 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 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 Change from before surgery to 10-12 months after surgery
Secondary 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 Change from before surgery to 10-12 months after surgery
Secondary Hip Sports Activity Scale (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
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