An interventional study of Surgical reattachment of hamstring tendons in Hamstring Tendon Injury, sponsored by Uppsala University. Completed at 10 sites in 2 countries. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Uppsala University · Not applicable, Interventional, and Treatment
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.
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 However, residual pain is common, ranging from 8 to 61% in a group of 203 patients and in a recent unpublished study the lower extremity functional score were similar in patients treated by either modality.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.
100 studies on the registry are indexed under Tendon Injuries; 27 are open to participants now.
This study's enrollment of 216 is above the median of 44 across 70 interventional studies indexed under Tendon Injuries.
Browse Tendon Injuries studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active rehabilitation program
Surgical reattachment of hamstring tendons using suture anchors followed by active rehabilitation program
Procedure: Surgical reattachment of hamstring tendons
operatively reattachment of the tendons using suture anchor
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.
Time frame: 24 months post inclusion
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.
Time frame: 24 months post inclusion
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).
Time frame: 24 months post inclusion
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).
Time frame: 24 months post inclusion
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).
Time frame: 24 months post inclusion
Hamstrings muscle volume and density
Volume and density measured by DIXON MRI at 24 months
Time frame: 24 months post inclusion
Adverse events
Peripheral neurological injury and symptoms, infection, wound complications, thromboembolic disease and any serious adverse events
Time frame: up until last follow-up at 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Within 6 months of study completion
Access criteria: Data access request will be reviewed by independent University leaders. Requestors will be required to sign DAA
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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