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Trial registered on ANZCTR


Registration number
ACTRN12620000927921
Ethics application status
Approved
Date submitted
24/06/2020
Date registered
17/09/2020
Date last updated
15/05/2024
Date data sharing statement initially provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Dual or single tendon anterior cruciate ligament reconstruction: a randomized controlled trial (DOSTAR study)
Scientific title
Dual or single tendon anterior cruciate ligament reconstruction: a randomized controlled trial comparing post-operative pain levels (DOSTAR study)
Secondary ID [1] 301621 0
Nil
Universal Trial Number (UTN)
U1111-1254-1570
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee anterior cruciate ligament tears 318010 0
Condition category
Condition code
Musculoskeletal 316038 316038 0 0
Other muscular and skeletal disorders
Surgery 316376 316376 0 0
Surgical techniques
Injuries and Accidents 316377 316377 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective randomized controlled trial (RCT) comparing patient outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two hamstring autograft constructs: 1) a graft constructed by folding a single hamstring tendon (harvested from the semitendinosus) four times (ST, 4 strand), or 2) a graft constructed by folding two hamstring tendons (harvested from the semitendinosus and gracilis tendons) two or three times (STG, 4/6 strand - the amount of folds of the harvested graft will be dependent on achieving the required minimum graft diameter specific to the patient).

The intervention (the surgical procedure with one of the two graft types) will be administered by the treating orthopaedic surgeon.

While both constructs are generally used interchangeably, for the purpose of trial registration the 'intervention' is the ST 4 strand surgical graft construct.

The surgical time for both techniques remains the same, and takes approximately 45 minutes in length (this is extended approximately 15-20 minutes for concomitant meniscal repair, undertaken if required). The appropriate intervention will be ensured in all patients via internal monitoring by the research team, liaising with a specific member of the nursing team that is independent to the research study team and on-site for all surgeries).

Following surgery, a standardized rehabilitation program will be followed by all patients, monitored by the patient's individual therapist. This rehabilitation program will require therapist visits 1-2 times per week as required over the initial 12 weeks (as is the case through standard clinical practice), followed by periodic supervised therapy from 3-9 months post-surgery.

Initially, all patients who do not have meniscal repair will be permitted to weight bear as tolerated using crutches. Where meniscal pathology and subsequent repair dictates restricted weight bearing or loaded range of motion, the meniscus pathology will govern this progress until full weight bearing is allowable.

Briefly and, standardized across all patients, early in-patient exercises will focus on regaining knee range of motion (ROM), patella mobility and pain/swelling reduction. From 2-3 weeks post-surgery, out-patient rehabilitation (including the exact exercises, together with recommended sets, repetitions and loads) will be dictated by individual patient physical conditioning and progression. An initial focus on exercises to restore movement and bilateral functional weight bearing strength will be prescribed. From 6-weeks post-surgery, a focus on single leg strength capacity will be undertaken, with a criterion-based return to jogging, as well as jumping and hopping exercises from 3 months post-surgery.
Intervention code [1] 317922 0
Treatment: Surgery
Comparator / control treatment
While both constructs are generally used interchangeably, for the purpose of trial registration the 'comparator' is the STG 4/6 strand surgical graft construct.
Control group
Active

Outcomes
Primary outcome [1] 324247 0
Visual Analogue Pain Scale at the surgical graft harvest site
Timepoint [1] 324247 0
6 months post-surgery
Secondary outcome [1] 384149 0
Visual Analogue Pain Scale at the knee
Timepoint [1] 384149 0
24 months post-surgery
Secondary outcome [2] 384150 0
International Knee Documentation Committee (IKDC) Subjective Knee Form - the IKDC is an overall 'composite' score (scored from 0-100) that seeks to evaluate a range of included parameters including symptoms (such as swelling and knee 'catching'), current activity participation and patient-perceived functional capacity, inclusive of stair ascent/descent, squatting, kneeling an running.
Timepoint [2] 384150 0
24 months post-surgery
Secondary outcome [3] 384151 0
Modified Cincinnati Knee Rating System Questionnaire (CKRS) - the CKRS is an overall 'composite' score (scored from 0-100) that seeks to evaluate a range of included parameters including pain, swelling and perceived knee instability, as well as walking capacity.
Timepoint [3] 384151 0
24 months post-surgery
Secondary outcome [4] 384152 0
Lysholm Knee Score (LKS) - the LKS is an overall 'composite' score (scored from 0-100) that seeks to evaluate a range of included parameters focused around the functional aspects of recovery (such as limping, need for support, squat and stair capacity).
Timepoint [4] 384152 0
24 months post-surgery
Secondary outcome [5] 384153 0
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) Score
Timepoint [5] 384153 0
24 months post-surgery
Secondary outcome [6] 384154 0
Noyes Sports Activity Rating Scale
Timepoint [6] 384154 0
24 months post-surgery
Secondary outcome [7] 384155 0
Graft laxity or stiffness (evaluated via the GNRB arthrometer)
Timepoint [7] 384155 0
24 months post-surgery
Secondary outcome [8] 384156 0
Active knee flexion and extension range of motion (ROM) - this will be measured via the use of a long arm goniometer, measuring the angle made by three anatomical landmarks in a supine position (greater trochanter at the hip, lateral femoral condyle at the knee and the lateral malleouls at the ankle).
Timepoint [8] 384156 0
24 months post-surgery
Secondary outcome [9] 384157 0
Single hop for distance - this will be assessed using a tape measure.
Timepoint [9] 384157 0
24 months post-surgery
Secondary outcome [10] 384158 0
Maximal isokinetic strength of the quadriceps muscles - this will be assessed using an isokinetic dynamometer (Isosport International, Gepps Cross, South Australia). Peak concentric knee extension strength (quadriceps) will be measured through a range of 0-90° of knee flexion, at a single isokinetic angular velocity of 90°/s.
Timepoint [10] 384158 0
24 months post-surgery
Secondary outcome [11] 384159 0
Magnetic Resonance Imaging (MRI) assessment - this will be employed to evaluate the integrity and maturation of the ACL graft.
Timepoint [11] 384159 0
6 and 12 months post-surgery
Secondary outcome [12] 384891 0
6 m timed hop - this will be measured using a stopwatch.
Timepoint [12] 384891 0
24 months post-surgery
Secondary outcome [13] 384892 0
Triple hop for distance - this will be assessed using a tape measure.
Timepoint [13] 384892 0
24 months post-surgery
Secondary outcome [14] 384893 0
Triple crossover hop for distance - this will be assessed using a tape measure.
Timepoint [14] 384893 0
24 months post-surgery
Secondary outcome [15] 384894 0
Maximal isokinetic strength of the hamstrings muscles - this will be assessed using an isokinetic dynamometer (Isosport International, Gepps Cross, South Australia). Peak concentric knee flexion strength (hamstrings) will be measured through a range of 0-90° of knee flexion, at a single isokinetic angular velocity of 90°/s.
Timepoint [15] 384894 0
24 months post-surgery
Secondary outcome [16] 384895 0
Magnetic Resonance Imaging (MRI) assessment - this will be employed to evaluate the extent and quality of hamstring tendon regeneration.
Timepoint [16] 384895 0
6 and 12 months post-surgery
Secondary outcome [17] 384896 0
Surgical Complications - the type of complication (outside of the routine operative pathway) and the overall umber of complications will be reported. These will be documented and obtained from the surgical operation notes, as well as via discussion with the treating orthopaedic surgeon.
Timepoint [17] 384896 0
Intra-operatively
Secondary outcome [18] 384897 0
Knee re-injuries (and associated re-operations) - information on the nature (i.e. mechanism) and timing of each re-injury, together with the timing of subsequent re-operation, will be be reported.

Should these be reported at the time of a designated study monitoring visit, they will be discussed with the patient and the treating orthopaedic surgeon, and documented accordingly. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information if required.

Should these be experienced and reported outside (or between) designated study monitoring visits, then the treating surgeon will consult the patient as would be the case in routine clinical practice. Again, the nature of the re-injury, further investigations and/or treatment will be discussed with the patient and the treating orthopaedic surgeon, and further reported and documented accordingly. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information required.
Timepoint [18] 384897 0
24 months post-surgery
Secondary outcome [19] 384898 0
Adverse Events - information on the type, severity and timing of each adverse event will be reported.

Should these be reported at the time of a designated study monitoring visit, they will be discussed with the patient and the treating orthopaedic surgeon, and documented accordingly based on professional clinical examination from the treating orthopaedic specialist. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information if required.

Should these be experienced and reported outside (or between) designated study monitoring visits, then the treating surgeon will consult the patient as would be the case in routine clinical practice. Again, the nature of the event, further investigations and/or treatment will be discussed with the patient and the treating orthopaedic surgeon, and further reported and documented accordingly. Subsequently, medical records and any other investigations (such as medical imaging) if deemed appropriate can provide further information required.

Adverse events will be graded as follows:

• Mild (Grade 1): Transient or mild discomfort; no limitation in activity; no intervention or therapy required (may include, though not limited to, events such as nausea).

• Moderate (Grade 2): Mild to moderate limitation in activity; some assistance may be needed; no or minimal medical intervention/therapy required (may include, though not limited to, events such as infection at the incision site).

• Severe (Grade 3): Marked limitation in activity; some assistance usually required; medical intervention/therapy required; hospitalization possible (may include, though not limited to, events such as transient nerve damage which may cause numbness, tingling, pain, and weakness).

• Extreme (Grade 4): Extreme limitation in activity; significant assistance required; significant medical intervention/therapy required; hospitalization or hospice care probable; potentially life-threatening (may include, though not limited to, events such as blood clots, haemorrhaging and/or internal bleeding).
Timepoint [19] 384898 0
These are reviewed at every associated post-operative clinical time-point (including intra-operatively, as well as 2 weeks and 3, 6, 12 and 24 months post-surgery).

Eligibility
Key inclusion criteria
Study Inclusion Criteria

• The individual is between the ages of 16 and 50 years.
• The individual clinically qualifies for ACLR surgery based on clinical examination and MRI.
• The ACLR is combined with meniscal surgery (meniscectomy or meniscal repair) which is addressed concomitantly with the ACLR.
• The individual has sustained the ACL tear within the last 12 months.
• The individual is not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol/substance abuse.
Minimum age
16 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study 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.
• The ACLR is combined with another ligament reconstruction or repair in the knee (multi- ligament knee reconstruction).
• Revision ACLR procedures.

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)
Once study eligibility has been determined and the patient has completed informed consent, patients recruited into this RCT will be randomly allocated in a 1:1 ratio to one of the two surgical study arms. The randomization schedule and concealed envelopes will be created and provided by a separate member of the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be undertaken via a random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Firstly, the mean (SD, range) of all subjective and objective measures collected will be presented for the designated pre- and post-operative time-points. Furthermore, limb symmetry indices (LSIs) will be calculated for the single limb hop and strength tests by dividing the peak values on the operated limb by that recorded on the unaffected limb. The mean LSIs for each of the aforementioned hop tests will be presented, and further categorized by the number and percentage of patients with LSIs less than 90% and greater than or equal to 90% (as per clinical recommendations of unsatisfactory and satisfactory performance, respectively). For knee laxity measures, these will be categorized (and compared between groups) based on side-to-side difference as normal (less than 3 mm), nearly normal (3-5 mm), abnormal (6-10 mm) and severely abnormal (greater than 10 mm), based on previous recommendations categorizing the degree of anterior drawer. Repeated measures Analysis of Variance (ANOVA) will be employed to evaluate change over the pre- and post-operative timeline in all PROMs, as well as post-operative change in objective measures including thigh girth, knee laxity, knee ROM, hop capacity and strength measures, for both surgical autograft groups. ANOVA will also be employed to evaluate differences between the operated and non-operated limbs in all tests, as well as between the two surgical cohorts in all tests over time.

The number respondents reporting each satisfaction score (Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied) across each of the Satisfaction items will be reported. The number (and type) of surgical complications, post-operative adverse events and re-injuries (knee and graft site) will be presented. The status of ACL integrity and maturation, together with hamstring tendon regeneration as demonstrated on MRI (in a subset of patients at 6 and 12 months) will be reported, though a more definitive scoring tool may be employed depending on availability at the time. Associations between demographic, injury history and clinical measures with MRI-based outcomes will be assessed using Pearson’s or Spearman’s correlation coefficient where appropriate. Where appropriate, statistical analysis will be performed using SPSS software (SPSS, Version 23.0, SPSS Inc., USA), while statistical significance will be determined at p<0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/09/2020
Actual
30/09/2020
Date of last participant enrolment
Anticipated
31/12/2022
Actual
16/05/2023
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
140
Accrual to date
Final
134
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16981 0
Bethesda Hospital - Claremont
Recruitment postcode(s) [1] 30644 0
6010 - Claremont

Funding & Sponsors
Funding source category [1] 306051 0
University
Name [1] 306051 0
University of Western Australia
Country [1] 306051 0
Australia
Funding source category [2] 306052 0
Charities/Societies/Foundations
Name [2] 306052 0
Orthopaedic Research Foundation Western Australia
Country [2] 306052 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway
Crawley, Western Australia, 6009
Country
Australia
Secondary sponsor category [1] 306513 0
None
Name [1] 306513 0
Address [1] 306513 0
Country [1] 306513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306278 0
University of Western Australia HREC
Ethics committee address [1] 306278 0
University of Western Australia
35 Stirling Highway
Crawley, Western Australia, 6009
Ethics committee country [1] 306278 0
Australia
Date submitted for ethics approval [1] 306278 0
19/12/2019
Approval date [1] 306278 0
16/03/2020
Ethics approval number [1] 306278 0
RA/4/20/5941

Summary
Brief summary
This is a prospective randomized controlled trial (RCT) comparing patient outcomes in patients undergoing anterior cruciate ligament reconstruction (ACLR) with one of two hamstring autograft constructs: 1) a graft constructed by folding a single hamstring tendon (harvested from the semitendinosus) four times (ST, 4 strand), or 2) a graft constructed by folding two hamstring tendons (harvested from the semitendinosus and gracilis tendons) two or three times (STG, 4/6 strand) (dependent on achieving the required minimum graft diameter). Patient outcomes will be collected and compared between the two surgical autograft cohorts over a 24 month post-operative period. This will include hamstring donor site morbidity (primary outcome variable), a range of patient reported outcome measures (PROMs), objective measures including anterior knee laxity, knee range of motion (ROM), peak isokinetic knee flexor (hamstrings) and extensor (quadriceps) strength, and single limb hop capacity, and radiological assessment of ACL graft integrity and hamstring graft site regeneration.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103342 0
Mr Peter D’Alessandro
Address 103342 0
Coastal Orthopaedics
Bethesda Hospital, 25 Queenslea Dr
Claremont, WA, 6010
Country 103342 0
Australia
Phone 103342 0
+61 8 9230 6333
Fax 103342 0
Email 103342 0
[email protected]
Contact person for public queries
Name 103343 0
Jay Ebert
Address 103343 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway
Crawley, WA, 6009
Country 103343 0
Australia
Phone 103343 0
+61 8 93869961
Fax 103343 0
Email 103343 0
[email protected]
Contact person for scientific queries
Name 103344 0
Jay Ebert
Address 103344 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway
Crawley, WA, 6009
Country 103344 0
Australia
Phone 103344 0
+61 8 93869961
Fax 103344 0
Email 103344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIA Randomised Controlled Trial Comparing Hamstring Tendon Versus Quadriceps Tendon Autograft In Anterior Cruciate Ligament Reconstruction: 2-Year Clinical Results2023https://doi.org/10.1016/j.jisako.2023.03.124
Dimensions AIDOSTAR: Dual or Single Hamstring Tendon for ACL Reconstruction. A Randomised Control Trial.2023https://doi.org/10.1016/j.jisako.2023.03.125
N.B. These documents automatically identified may not have been verified by the study sponsor.