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The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment

Not Applicable
Completed
Conditions
Hamstring Tendon Injury
Registration Number
NCT03311997
Lead Sponsor
Uppsala University
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 with patients treated with suture anchor reattachment of the tendons using the Perth Hamstrings Assessment Tool (PHAT) at 24 months.

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 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 However, residual pain is common, ranging from 8 to 61% in a group of 203 patients and in a recent unpublished study the lower extremity functional score were similar in patients treated by either modality.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, non-inferiority trial comparing operative to non-operative treatment of proximal hamstrings avulsions. The study will include a concurrent prospective observational cohort.

The eligible study population will consist of patients with an acute, avulsion of hamstrings tendons diagnosed in a hospital in Sweden, or Norway 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 will be collected at follow-up visit and a MRI will be performed at 24 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
216
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Perth Hamstrings Assessment Tool (PHAT)24 months post inclusion

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.

Secondary Outcome Measures
NameTimeMethod
Timed step test24 months post inclusion

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).

Maximal isokinetic strength of hamstrings24 months post inclusion

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).

Single hop test24 months post inclusion

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).

Lower extremity functional scale (LEFS)24 months post inclusion

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.

Hamstrings muscle volume and density24 months post inclusion

Volume and density measured by DIXON MRI at 24 months

Trial Locations

Locations (10)

Bergen University Hospital

🇳🇴

Bergen, Norway

Oslo University Hospital

🇳🇴

Oslo, Norway

Linköping University Hospital

🇸🇪

Linköping, Sweden

Malmö University Hospital

🇸🇪

Malmö, Sweden

Södersjukhuset

🇸🇪

Stockholm, Sweden

Danderyd hospital

🇸🇪

Stockholm, Sweden

Norrlands University Hospital

🇸🇪

Umeå, Sweden

Uppsala University Hospital

🇸🇪

Uppsala, Sweden

Örebro University Hospital

🇸🇪

Örebro, Sweden

Östersund Hospital

🇸🇪

Östersund, Sweden

Bergen University Hospital
🇳🇴Bergen, Norway

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