The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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 surgeon. The literature is totally devoid of studies comparing the two treatment options; non-operative and operative treatment. In Sweden, it is probably more common to treat these injuries nonoperatively. This is in contrast to existing literature that suggests that better outcomes are expected with operative treatment. However, there is a very clear publication bias in the literature. In fact, of the more than 40 published clinical studies, only a handful mentions the results of non-operatively treated injuries. In a systematic review examining 13 original studies, patient satisfaction ranged from 88% to 100% after surgical treatment. In nine of the studies strength of hamstrings were reported and ranged from 78% to 101% of the uninjured side. However, residual pain is common, ranging from 8 to 61% in a group of 203 patients and in a recent unpublished study the lower extremity functional score were similar in patients treated by either modality. Additionally, serious nerve injuries after surgery have been reported and infection, anchor failure and re-rupture occur. The reoperation rate in a study by Sarimo et al. was 12%. This study is a prospective, multicentre, preference-tolerant, randomized controlled trial comparing operative to non-operative treatment of proximal hamstrings avulsions. The study will include a concurrent prospective cohort observational study. The eligible study population will consist of patients with an acute, avulsion of hamstrings tendons diagnosed in a hospital in Sweden, Norway or Finland and subsequently referred to one of the study sites. All patients fulfilling the inclusion and not meeting the exclusion criteria will be asked to participate in the study. After the patient´s enrolment has been confirmed and informed consent is obtained a set of questionnaires is provided for background data on medical history, activity levels and a recall assessment of the pre-injury functional status. When these questionnaires are completed, the patient is randomized. If the patient is randomized to non-operative treatment an appointment with a physiotherapist follows and the study rehabilitation protocol is explained. If the patient is randomized to surgery, the procedure is scheduled at the earliest convenient time but no later than 2 weeks from inclusion. The surgical procedure and rehabilitation protocol is standardized among sites. The same rehabilitation protocol is used for both treatment groups. Participation in this study will last 24 months. In-person participant follow-up visits will occur at enrollment (baseline), at-surgery, 3 months, 6 months, 12 months and 24 months post-surgery. Data for outcomes and radiographs will be collected at follow-up visit.

Official Title
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The Proximal Hamstring Avulsion Clinical Trial - Nonoperative Treatment Compared With Suture Anchor Reinsertion of Proximal Hamstrings Avulsions

Conditions
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Hamstring Tendon Injury

Intervention / Treatment
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* Procedure: Surgical reattachment of hamstring tendons


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-operative treatment<br>Active rehabilitation program | |
| Active Comparator: Operative treatment<br>Surgical reattachment of hamstring tendons using suture anchors followed by active rehabilitation program | Procedure: Surgical reattachment of hamstring tendons<br>* operatively reattachment of the tendons using suture anchor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perth Hamstrings Assessment Tool (PHAT) | The PHAT is a 8-item instrument that measures pain, function and discomfort of the hamstrings. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). The maximum score is 100 indicating no symptoms and high function. | 24 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity functional scale (LEFS) | LEFS is a 30-item instrument that measure patient perceived function of the lower extremities. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). The maximum possible score is 80 points, indicating very high function. | 24 months post surgery | 
| Maximal isokinetic strength of hamstrings | The difference between the two treatment groups in the mean ratio between the injured and uninjured side of the maximum isokinetic force during knee flexion and hip extension measured by a dynamometer. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). | 24 months post surgery | 
| Timed step test | The difference between the two treatment groups in the mean ratio between the injured and uninjured side of the functional timed step test. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). | 24 months post surgery | 
| Single hop test | The difference between the two treatment groups in the mean ratio between the injured and uninjured side of the single leg hop test. Primary endpoint at 24 months (measured at 3, 6, 12, and 24 months). | 24 months post surgery | 
| Hamstrings muscle volume and density | Volume and density measured by computerized tomography at 24 months | 24 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Hamstring, Suture