The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment

Hamstring Tendon Injury Clinical Trial

— PHACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03311997
• Other study ID #: UU2017/170
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: September 22, 2022

Study information

• Verified date: April 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 However, residual pain is common, ranging from 8 to 61% in a group of 203 patients and in a recent unpublished study the lower extremity functional score were similar in patients treated by either modality.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 information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hamstring Tendon Injury
• Tendon Injuries

Intervention

Procedure:
• Surgical reattachment of hamstring tendons
operatively reattachment of the tendons using suture anchor

Locations

Country	Name	City	State
Norway	Bergen University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Sweden	Linköping University Hospital	Linköping
Sweden	Malmö University Hospital	Malmö
Sweden	Örebro University Hospital	Örebro
Sweden	Östersund Hospital	Östersund
Sweden	Danderyd hospital	Stockholm
Sweden	Södersjukhuset	Stockholm
Sweden	Norrlands University Hospital	Umeå
Sweden	Uppsala University Hospital	Uppsala

Sponsors (8)

Lead Sponsor	Collaborator
Uppsala University	Karolinska Institutet, Linkoeping University, Lund University, Örebro University, Sweden, Umeå University, University of Bergen, University of Oslo

Countries where clinical trial is conducted

Norway,  Sweden, 

References & Publications (7)

Barry MJ, Palmer WE, Petruska AJ. A Proximal Hamstring Injury--Getting Off a Slippery Slope. JAMA Intern Med. 2016 Jan;176(1):15-6. doi: 10.1001/jamainternmed.2015.6795. No abstract available. — View Citation

Blakeney WG, Zilko SR, Edmonston SJ, Schupp NE, Annear PT. Proximal hamstring tendon avulsion surgery: evaluation of the Perth Hamstring Assessment Tool. Knee Surg Sports Traumatol Arthrosc. 2017 Jun;25(6):1936-1942. doi: 10.1007/s00167-016-4214-y. Epub 2016 Jun 25. — View Citation

Harris JD, Griesser MJ, Best TM, Ellis TJ. Treatment of proximal hamstring ruptures - a systematic review. Int J Sports Med. 2011 Jul;32(7):490-5. doi: 10.1055/s-0031-1273753. Epub 2011 May 11. — View Citation

Iyer VG. Iatrogenic injury to the sciatic nerve during surgical repair of proximal hamstring avulsion. Muscle Nerve. 2015 Sep;52(3):465-6. doi: 10.1002/mus.24678. Epub 2015 May 14. No abstract available. — View Citation

Mehta SP, Fulton A, Quach C, Thistle M, Toledo C, Evans NA. Measurement Properties of the Lower Extremity Functional Scale: A Systematic Review. J Orthop Sports Phys Ther. 2016 Mar;46(3):200-16. doi: 10.2519/jospt.2016.6165. Epub 2016 Jan 26. — View Citation

Sarimo J, Lempainen L, Mattila K, Orava S. Complete proximal hamstring avulsions: a series of 41 patients with operative treatment. Am J Sports Med. 2008 Jun;36(6):1110-5. doi: 10.1177/0363546508314427. Epub 2008 Mar 4. — View Citation

van der Made AD, Reurink G, Gouttebarge V, Tol JL, Kerkhoffs GM. Outcome After Surgical Repair of Proximal Hamstring Avulsions: A Systematic Review. Am J Sports Med. 2015 Nov;43(11):2841-51. doi: 10.1177/0363546514555327. Epub 2014 Nov 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Peripheral neurological injury and symptoms, infection, wound complications, thromboembolic disease and any serious adverse events	up until last follow-up at 24 months
Primary	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 inclusion
Secondary	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 inclusion
Secondary	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 inclusion
Secondary	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 inclusion
Secondary	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 inclusion
Secondary	Hamstrings muscle volume and density	Volume and density measured by DIXON MRI at 24 months	24 months post inclusion