The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment (PHACT)

April 9, 2024 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 However, residual pain is common, ranging from 8 to 61% in a group of 203 patients and in a recent unpublished study the lower extremity functional score were similar in patients treated by either modality.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

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Bergen University Hospital
      • Oslo, Norway
        • Oslo University Hospital
  • Sweden
      • Linköping, Sweden, 581 85
        • Linköping University hospital
      • Malmö, Sweden
        • Malmö University Hospital
      • Stockholm, Sweden, 118 83
        • Södersjukhuset
      • Stockholm, Sweden, 182 88
        • Danderyd Hospital
      • Umeå, Sweden, 581 85
        • Norrlands University Hospital
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital
      • Örebro, Sweden, 701 85
        • Orebro University Hospital
      • Östersund, Sweden, 831 83
        • Östersund hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non-operative treatment
Active rehabilitation program
Active Comparator: Operative treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perth Hamstrings Assessment Tool (PHAT)
Time Frame: 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.
24 months post inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity functional scale (LEFS)
Time Frame: 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.
24 months post inclusion
Maximal isokinetic strength of hamstrings
Time Frame: 24 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).
24 months post inclusion
Timed step test
Time Frame: 24 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).
24 months post inclusion
Single hop test
Time Frame: 24 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).
24 months post inclusion
Hamstrings muscle volume and density
Time Frame: 24 months post inclusion
Volume and density measured by DIXON MRI at 24 months
24 months post inclusion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up until last follow-up at 24 months
Peripheral neurological injury and symptoms, infection, wound complications, thromboembolic disease and any serious adverse events
up until last follow-up at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

University of Oslo
Karolinska Institutet
Lund University
University of Bergen
Umeå University
Linkoeping University
Örebro University, Sweden

Investigators

  • Principal Investigator: Kenneth Jonsson, MD., Ph.D, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2017

Primary Completion (Actual)

September 22, 2022

Study Completion (Actual)

September 22, 2022

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU2017/170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Within 6 months of study completion

IPD Sharing Access Criteria

Data access request will be reviewed by independent University leaders. Requestors will be required to sign DAA

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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