The Proximal Hamstring Avulsion Clinical Trial - Operative or Nonoperative Treatment

NCT03311997 | Completed

• 1 other identifier: UU2017/170
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 10

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.

Conditions

Hamstring Tendon Injury

Keywords

RCT; Hamstring; Suture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Lower extremity functional scale (LEFS)

  24 months post inclusion

• Maximal isokinetic strength of hamstrings

  24 months post inclusion

• Timed step test

  24 months post inclusion

• Single hop test

  24 months post inclusion

• Hamstrings muscle volume and density

  24 months post inclusion

Other Outcomes (1)

• Adverse events

  up until last follow-up at 24 months

Study Arms (2)

Non-operative treatment

NO INTERVENTION

Active rehabilitation program

Operative treatment

ACTIVE COMPARATOR

Surgical reattachment of hamstring tendons using suture anchors followed by active rehabilitation program

Procedure: Surgical reattachment of hamstring tendons

Interventions

Surgical reattachment of hamstring tendons PROCEDURE

operatively reattachment of the tendons using suture anchor

Operative treatment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Linkoeping University: collaborator
• Lund University: collaborator
• Örebro University, Sweden: collaborator
• Umeå University: collaborator
• Karolinska Institutet: collaborator
• University of Oslo: collaborator
• University of Bergen: collaborator

Study Sites (10)

Bergen University Hospital

Bergen, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Linköping University Hospital

Linköping, 581 85, Sweden

Location

Malmö University Hospital

Malmo, Sweden

Location

Örebro University Hospital

Örebro, 701 85, Sweden

Location

Östersund Hospital

Östersund, 831 83, Sweden

Location

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Danderyd hospital

Stockholm, 182 88, Sweden

Location

Norrlands University Hospital

Umeå, 581 85, Sweden

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (9)

• 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.

  PMID: 25847226 BACKGROUND

• 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.

  PMID: 27344550 BACKGROUND

• 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.

  PMID: 21563032 BACKGROUND

• 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.

  PMID: 26618607 BACKGROUND

• 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.

  PMID: 26813750 BACKGROUND

• 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.

  PMID: 18319349 BACKGROUND

• 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.

  PMID: 25384502 BACKGROUND

• Pihl E, Laszlo S, Rosenlund AM, Kristoffersen MH, Schilcher J, Hedbeck CJ, Skorpil M, Micoli C, Eklund M, Skoldenberg O, Frihagen F, Jonsson KB. Operative versus Nonoperative Treatment of Proximal Hamstring Avulsions. NEJM Evid. 2024 Aug;3(8):EVIDoa2400056. doi: 10.1056/EVIDoa2400056. Epub 2024 Jul 18.

  PMID: 39023393 DERIVED

• Pihl E, Kristoffersen MH, Rosenlund AM, Laszlo S, Berglof M, Ribom E, Eriksson K, Frihagen F, Mattila VM, Schilcher J, Eklund M, Snellman G, Skorpil M, Skoldenberg O, Hedbeck CJ, Jonsson K. The proximal hamstring avulsion clinical trial (PHACT)-a randomised controlled non-inferiority trial of operative versus non-operative treatment of proximal hamstrings avulsions: study protocol. BMJ Open. 2019 Sep 13;9(9):e031607. doi: 10.1136/bmjopen-2019-031607.

  PMID: 31519683 DERIVED

Study Officials

• Kenneth Jonsson, MD., Ph.D

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Personell assessing functional performance of patients are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 17, 2017
• Study Start: October 24, 2017
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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

Locations

NO (2); SE (8)