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Completed

NCT Number: NCT03868826

Pain, Function and Quality of Life Before and After Treatment of Hamstring Avulsion

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Signe Kierkegaard

Horsens, Danmark, DK-8700, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthopaedic surgery and/or rehabilitation

Procedure

The avulsion is repaired and hereafter the patient follows rehabilitation. Some are treated conservatively and only follow rehabilitation.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Horsens Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2019
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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