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Trial registered on ANZCTR


Registration number
ACTRN12621000913875
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
14/07/2021
Date last updated
14/07/2021
Date data sharing statement initially provided
14/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to assess two rehabilitation regimes following surgical repair of hamstring tendon insertion injuries
Scientific title
Hamstring strength following accelerated versus conventional rehabilitation after surgical repair of acute proximal hamstring tendon avulsions in adults: a randomised controlled trial
Secondary ID [1] 303383 0
None
Universal Trial Number (UTN)
Trial acronym
PHARRLAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute proximal hamstring tendon avulsion 320693 0
Condition category
Condition code
Musculoskeletal 318538 318538 0 0
Other muscular and skeletal disorders
Injuries and Accidents 319307 319307 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group One: Conventional rehabilitation. Hinged knee brace applied post-operatively locked at 30 degrees of flexion. Toe-touch weight bearing for 2 weeks followed by 4 weeks of partial (50%) weight bearing. Full weight bearing can begin from the start of week 7. Short stride length prescribed. Isometric lower limb exercises (excluding hamstring) immediately. These exercises were advised for 15 minutes twice daily. Isometric hamstring exercises from 6 weeks. These were advised for 15 minutes twice daily. Rehabilitation to progress from here guided by the patients own physiotherapist. Personal and face to face physiotherapy advised and guided by patients progress. Compliance and current function was monitored via phone calls by the research team. Patients were contact at 1-2 weeks to check early complicance. Then they were contacted via phone/email at 6 weeks and 12 weeks. This rehabilitation would continue to 3 months then both groups could progress as able with no restriction.
Intervention code [1] 319709 0
Rehabilitation
Intervention code [2] 320267 0
Treatment: Other
Comparator / control treatment
Group Two: No brace used. Full weight bear as tolerated. Stride length as tolerated. Early isometic and eccentric hamstring exercises guided by physiotherapist. No limitation to amount but it waqs recommended to exercise for short periods but often. Progress in a personalised manner with surgeon/physiotherapist guidance. Compliance and current function was monitored via phone calls by the research team. Patients were contact at 1-2 weeks to check early complicance. Then they were contacted via phone/email at 6 weeks and 12 weeks.

This rehabilitation would continue to 3 months then both groups could progress as able with no restriction. This group was "accelerated" as they were immediately allowed to full weight bear and push they exercises to their own personal limits. Early eccentric contraction was permitted also.
Control group
Active

Outcomes
Primary outcome [1] 326506 0
Peak isometric hamstring torque using a hand-held dynamometer. The same dynamometer will be used by for all patients by the same research physiotherapist.
Timepoint [1] 326506 0
6 months post-surgery
Secondary outcome [1] 391720 0
Perth Hamstring Assessment Tool (PHAT)
Timepoint [1] 391720 0
6, 12 and 24 months post-surgery
Secondary outcome [2] 391721 0
Lower Extremity Functional Score (LEFS)
Timepoint [2] 391721 0
6, 12 and 24 months post-surgery
Secondary outcome [3] 391722 0
Tegner activity score to assess level of sporting function
Timepoint [3] 391722 0
6, 12 and 24 months post-surgery
Secondary outcome [4] 391723 0
Global Rating of Change (GRC) Scale to assess overall patients perception of change in health status
Timepoint [4] 391723 0
6, 12 and 24 months post-surgery
Secondary outcome [5] 391724 0
Satisfaction will be assessed using a categorical tool will be employed: 1 = very satisfied; 2 = somewhat satisfied; 3 = somewhat dissatisfied; 4 = very dissatisfied.
Timepoint [5] 391724 0
6, 12 and 24 months post-surgery
Secondary outcome [6] 394093 0
Thigh girth will be assessed by measuring the the girth of both limbs 10cm above the superior pole of the patella
Timepoint [6] 394093 0
6, 12 and 24 months post-surgery
Secondary outcome [7] 394094 0
Active knee extension test will be performed and the angle documented using a goniometer
Timepoint [7] 394094 0
6, 12 and 24 months post-surgery
Secondary outcome [8] 394095 0
4-hop test battery will be conducted inclusive of single hop for distance, 6 metre timed hop, triple hop for distance and triple crossover hop for distance
Timepoint [8] 394095 0
6, 12 and 24 months post-surgery

Eligibility
Key inclusion criteria
- Age 18-65 years.
- Presenting to the surgeon and operated on within 42 days of their injury.
- Physical examination supporting the diagnosis; positive hip extension test, palpable defect and/or local tenderness and haematoma.
- MRI showing complete acute avulsion of at least two of three tendons from the footprint at the ischial tuberosity.
- Patients able to give written informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• The individual is unable or unwilling to sign the Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board.
- The individual is unable or unwilling to follow the designated rehabilitation protocol.
- The individual is classified as morbidly obese (>40 BMI).
- The individual is skeletally immature.
- Revision procedures.
- Isolated semimembranosus ruptures.
- Ruptures > 4cm away from the ischial tuberosity
- The individual is currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol/substance abuse

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori sample size power calculation has been determined based on the recommendations of Cohen, using G-Power (Dusseldorf, Germany). Pilot data already collected in patients after proximal hamstring repair has highlighted the significant side-to-side limb asymmetry observed at 6 months post-surgery in peak isokinetic hamstring torque/strength. Therefore, based on this pilot data and given the proposed role of an accelerated rehabilitation regimen in restoring these strength deficits at a faster rate, for an anticipated large effect size (d=0.80) in the primary outcome variable (limb symmetry index for peak isokinetic hamstring torque at 6 months post-surgery), a total of 26 patients are required in each group to reveal differences at alpha 0.05 with 80% power. We aim to recruit and clinically evaluate 58 patients (i.e. an additional 10% in each group) to allow for attrition over the 24-month assessment period.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/03/2021
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
58
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 18685 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 18686 0
Bethesda Hospital - Claremont
Recruitment hospital [3] 18687 0
Mount Hospital - Perth
Recruitment hospital [4] 18688 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 33125 0
6000 - Perth
Recruitment postcode(s) [2] 33124 0
6010 - Claremont
Recruitment postcode(s) [3] 33123 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 307806 0
Hospital
Name [1] 307806 0
Fiona Stanley Hospital
Country [1] 307806 0
Australia
Funding source category [2] 309142 0
Hospital
Name [2] 309142 0
Bethesda Hospital
Country [2] 309142 0
Australia
Funding source category [3] 309143 0
Hospital
Name [3] 309143 0
St John of God Hospital
Country [3] 309143 0
Australia
Primary sponsor type
Other
Name
Coastal orthopaedics
Address
Coastal Orthopaedics
Bethesda Hospital
25 Queenslea Drive
Claremont
Perth
Western Australia
6010
Country
Australia
Secondary sponsor category [1] 308509 0
None
Name [1] 308509 0
NA
Address [1] 308509 0
NA
Country [1] 308509 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307812 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 307812 0
Human Ethics Office
Office of Research
The University of Western Australia
35 Stirling Highway
Perth WA 6009
Ethics committee country [1] 307812 0
Australia
Date submitted for ethics approval [1] 307812 0
01/02/2021
Approval date [1] 307812 0
18/03/2021
Ethics approval number [1] 307812 0
2021/ET000117

Summary
Brief summary
This is a prospective randomised controlled trial (RCT) comparing the outcomes for patients undergoing proximal hamstring tendon avulsion repair with two different post-operative rehabilitation regimes. The first regime includes a period of brace immobilisation and limited weight-bearing with a gradual progression of physiotherapy. The second regime allows immediate full-weight bearing with an accelerated rehabilitation program of physiotherapy.

Patient outcomes will be collected and compared between the two rehabilitation regime cohorts over a 24-month post-operative period. This will include validated Patient Reported Outcome Measures (PROMs) investigating pain, symptoms and patient satisfaction, and objective measures of hip range of motion (ROM), muscle girth, peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength. Overall satisfaction and assessment of complications will be assessed throughout.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108586 0
Mr Peter D'Alessandro
Address 108586 0
Coastal Orthopaedics, Orthopaedic Research Foundation of Western Australia (ORFWA) and UWA FMDHS
Bethesda Hospital, 25 Queenslea Dr
Claremont, WA, 6010
Country 108586 0
Australia
Phone 108586 0
+61 413338339
Fax 108586 0
Email 108586 0
peter@coastalorthopaedics.com.au
Contact person for public queries
Name 108587 0
Mr Peter D'Alessandro
Address 108587 0
Coastal Orthopaedics, Orthopaedic Research Foundation of Western Australia (ORFWA) and UWA FMDHS
Bethesda Hospital, 25 Queenslea Dr
Claremont, WA, 6010
Country 108587 0
Australia
Phone 108587 0
+61 413338339
Fax 108587 0
Email 108587 0
peter@coastalorthopaedics.com.au
Contact person for scientific queries
Name 108588 0
Mr Peter D'Alessandro
Address 108588 0
Coastal Orthopaedics, Orthopaedic Research Foundation of Western Australia (ORFWA) and UWA FMDHS
Bethesda Hospital, 25 Queenslea Dr
Claremont, WA, 6010
Country 108588 0
Australia
Phone 108588 0
+61 413338339
Fax 108588 0
Email 108588 0
peter@coastalorthopaedics.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not plan to share the individual patient data but we will share the results of the study with all patients involved upon completion.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10543Study protocol    381382-(Uploaded-10-02-2021-14-02-26)-Study-related document.docx



Results publications and other study-related documents

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