NCT03868826

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 6, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2024

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

March 4, 2019

Last Update Submit

May 26, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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

  • 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

  • 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 Outcomes (3)

  • Knee flexion strength of contralateral leg (Newton meters per kilogram)

    Change from before surgery to 10-12 months after surgery

  • Hip extension strength of contralateral leg (Newton meters per kilogram)

    Change from before surgery to 10-12 months after surgery

  • Hip Sports Activity Scale (0-8 scale)

    Change from before surgery to 10-12 months after surgery on the 0-8 scale

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with hamstring avulsion

You may qualify if:

  • Patients eligible for treatment of hamstring avulsion

You may not qualify if:

  • Conditions that contraindicate muscle strength testing e.g. cancer and neurological conditions
  • Patients that do not speak or understand Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Signe Kierkegaard

Horsens, Danmark, DK-8700, Denmark

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 11, 2019

Study Start

March 6, 2019

Primary Completion

March 6, 2024

Study Completion

October 6, 2024

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations