Status:
COMPLETED
The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Linkoeping University
Lund University
Conditions:
Hamstring Tendon Injury
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief Summary
The purpose of this study is to provide reliable evidence on how to best treat proximal hamstrings avulsions, and our primary aim is to compare the reported outcome of patients treated non-operatively...
Detailed Description
The treatment of proximal hamstrings avulsions is controversial and patients with this injury will get treatment recommendations based not on scientific evidence but on personal preferences of their s...
Eligibility Criteria
Inclusion
- Inclusion criteria
- age of the patient at injury between 30 and 70
- MRI shows a complete avulsion of at least two of three tendons from the insertion at the ischial tubercule
- physical examination supports the diagnosis; e.g. a positive hip extension test, palpable defect and/or local tenderness and hematoma
- patient has a moderate to high activity level
- patient has linguistic and mental ability to understands study program explained in Swedish, Finnish, Norwegian or English
- time from injury to inclusion in study is less than 4 weeks
- A patient with moderate to high activity level is defined as any patient that is ambulatory in the community and participates in some type of strenuous activity at work or in spare time on a regular basis. Any patient that skis, goes for an occasional run, takes long walks in the woods, climbs ladders or physically manages a large garden have an activity level that is at least moderate.
- Exclusion criteria
- diabetes with secondary complications
- previous major lower extremity injury or disease with sequelae
- moderate or severe liver, pulmonary, kidney, psychiatric or heart disease that significantly increases the risk for complications after operative treatment
- severe obesity (BMI\>35)
- alcohol or drug abuse
- high energy injury or combinations of injuries affecting the lower extremity
Exclusion
Key Trial Info
Start Date :
October 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 22 2022
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03311997
Start Date
October 24 2017
End Date
September 22 2022
Last Update
April 11 2024
Active Locations (10)
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1
Bergen University Hospital
Bergen, Norway
2
Oslo University Hospital
Oslo, Norway
3
Linköping University Hospital
Linköping, Sweden, 581 85
4
Malmö University Hospital
Malmo, Sweden