The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment (NCT03311997) | Clinical Trial Compass
CompletedNot Applicable
The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment
Norway, Sweden216 participantsStarted 2017-10-24
Plain-language 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 with patients treated with suture anchor reattachment of the tendons using the Perth Hamstrings Assessment Tool (PHAT) at 24 months.
Who can participate
Age range30 Years ā 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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