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Trial registered on ANZCTR
Registration number
ACTRN12624000560594
Ethics application status
Approved
Date submitted
16/04/2024
Date registered
3/05/2024
Date last updated
3/05/2024
Date data sharing statement initially provided
3/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparison of clinical outcomes in paediatric patients undergoing anterior cruciate ligament reconstruction with or without additional iliotibial band tenodesis
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Scientific title
A randomized controlled study comparing anterior cruciate ligament reconstruction with or without additional iliotibial band tenodesis in paediatric patients
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Secondary ID [1]
311978
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament tears
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Condition category
Condition code
Musculoskeletal
330267
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0
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Other muscular and skeletal disorders
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Surgery
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0
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Surgical techniques
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Injuries and Accidents
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a prospective randomized controlled trial (RCT) comparing patient outcomes in paediatric patients undergoing anterior cruciate ligament reconstruction (ACLR) with or without a concomitant iliotibial band tenodesis.
The intervention (the surgical procedure with or without a concomitant iliotibial band tenodesis) will be administered by the treating orthopaedic surgeon.
While both options are available to patients through a standard clinical pathway and individual surgeons may perform ACLR either with or without tenodesis through their own standard clinical pathway, for the purpose of trial registration the 'intervention' will allude to ACLR with the additional tenodesis.
The surgical time for ACLR lasts approximately 30 minutes, with the tenodesis adding an extra (approximately) 10-15 minutes to the operative procedure. 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).
The ACLR procedure will be performed in a standardized fashion using a four-strand autologous hamstring autograft. If the diameter of the graft is found to be less than 8mm, semitendinosus will be tripled (5 strand graft) providing a greater graft diameter. Femoral tunnels will be drilled using an anteromedial portal technique, with femoral fixation provided by an Endobutton or equivalent. Tibial fixation will be provided by interference screw.
For patients randomised to receive the concomitant tenodesis, this will also be performed in a standardized fashion. Specifically, surgeons will make an oblique skin incision between the lateral epicondyle and Gerdy’s tubercle, measuring approximately 5cm. A 1cm wide by 8cm long strip of ITB is fashioned, leaving the Gerdy’s tubercle attachment intact. A No. 1 vicryl whip suture is applied to the free end, leaving the needle attached. The graft is then tunnelled under the fibular collateral ligament (FCL) and attached to the femur with a Richards’ staple, just distal to the intermuscular septum, proximal to the femoral insertion of the FCL. Fixation is performed with the knee at 70° flexion, neutral rotation. Minimal tension is applied to the graft. The free end is then looped back onto itself and sutured using the No. 1 vicryl.
Following surgery, a standardized rehabilitation program will be followed by all patients, monitored by the patient's individual physiotherapist, generally in a one-to-one environment. This rehabilitation program will require a therapist visit every 1-2 weeks, over the initial 12 weeks (as is the case through standard clinical practice), followed by periodic supervised therapy from 3-9 months post-surgery (these sessions after 3 months are once per 3-4 weeks. All supervised sessions last approximately 30-45 minutes, and are supplemented by a progressive home-based program. An attempt to monitor rehabilitation adherence will be made using an activity diary, combined with therapist-patient discussion at the time of supervised sessions. 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.
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Rehabilitation
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Comparator / control treatment
While both options are available to patients and performed at the discretion of the surgeon, for the purpose of trial registration the 'comparator' is anterior cruciate ligament reconstruction without a concomitant iliotibial band tenodesis.
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Control group
Active
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Outcomes
Primary outcome [1]
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Anteroposterior knee laxity
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Assessment method [1]
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KT-1000 knee arthrometer
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Timepoint [1]
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6 months post-surgery
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Secondary outcome [1]
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Knee Pain
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Assessment method [1]
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Visual Analogue Pain Scale at the knee
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Timepoint [1]
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24 months post-surgery
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Secondary outcome [2]
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A composite outcome score that includes individual items of knee pain, symptoms and functional capacity
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Assessment method [2]
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Paediatric version of the International Knee Documentation Committee (Pedi-IKDC) Subjective Knee Form
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Timepoint [2]
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24 months post-surgery
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Secondary outcome [3]
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A composite outcome score that includes individual items of knee pain, symptoms and recreational and sports capacity
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Assessment method [3]
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Knee Injury and Osteoarthritis Outcome Score for Children (KOOS-Child)
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Timepoint [3]
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24 months post-surgery
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Secondary outcome [4]
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Activity Level
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Assessment method [4]
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Marx Activity Rating Scale
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Timepoint [4]
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24 months post-surgery
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Secondary outcome [5]
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Active knee flexion range
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Assessment method [5]
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This will be measured via the use of a long arm goniometer (with the knee in full flexion), 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 malleolus at the ankle).
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Timepoint [5]
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24 months post-surgery
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Secondary outcome [6]
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Maximal isokinetic strength of the quadriceps muscle group
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Assessment method [6]
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This will be assessed using an isokinetic dynamometer. 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.
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Timepoint [6]
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24 months post-surgery
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Secondary outcome [7]
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Functional single-limb hop capacity
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Assessment method [7]
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In the following order, this will include: 1) the Single Hop for Distance (SHD), 2) the 6-meter Timed Hop (6MTH), 3) the Triple Hop for Distance (THD) and 4) the Triple Crossover Hop for Distance (TCHD). The SHD requires participants to execute a forwards (horizontal) hop, for the longest possible distance, both taking off and landing on that same leg. The 6MTH requires participants to hop six meters as fast as possible using only the tested limb, in a forwards (horizontal) direction. The THD requires the participant to execute three consecutive hops in a forwards (horizontal) direction, aiming to achieve the longest possible distance, again with the final landing to be held. The TCHD also requires the participant to perform three consecutive hops for the greatest distance, though navigating back and forth over a 15cm width mat.
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Timepoint [7]
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24 months post-surgery
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Secondary outcome [8]
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Surgical Complications
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Assessment method [8]
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The type of complication (outside of the routine operative pathway) and the overall number 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.
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Timepoint [8]
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Intra-operatively
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Secondary outcome [9]
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Knee re-injuries (and associated re-operations)
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Assessment method [9]
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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.
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Timepoint [9]
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24 months post-surgery
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Secondary outcome [10]
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Adverse Events
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Assessment method [10]
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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).
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Timepoint [10]
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These are reviewed at every associated post-operative clinical (or research) time-point, including intra-operatively and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-surgery.
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Secondary outcome [11]
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Lower limb deformity and/or growth arrest
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Assessment method [11]
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Assessment of leg-length deformity will be assessed by measuring the true and apparent leg-lengths of ipsilateral and contralateral lower limbs. A leg-length difference of more than 1cm is considered clinically significant. Assessment of angular deformity will be assessed clinically from general observation. Abnormal clinical findings include medial aspect of knees touching, wide intermalleolar distance (>8cm). If there is any suspicion from the clinician, imaging will be performed (below).
Patients will be asked to have lower limb weightbearing, anteroposterior and lateral EOS radiographs (EOS Imaging, Cambridge, MA) undertaken if there is clinical concern of leg-length or angular deformity. EOS radiographs are capable of simultaneous capture of biplanar X-ray images by slot scanning of the whole body using ultra-low radiation does. They allow for a three-dimensional surface reconstruction of the skeletal system using a special software. Parts of the skeletal system in X-ray images and 3D-reconstructed models appear in true 1:1 scale for size and volume, thus spinal and vertebral parameters, lower limb axis lengths and angles, as well as any relevant clinical parameters in orthopaedic practice can be very precisely measured and calculated. Femoral length will be estimated by measuring the distance between superior aspect of the femoral head and the distal portion of the medial condyle. Tibial length will be determined by measuring the distance between the medial tibial plateau and the tibial plafond. The sum of the femoral and tibial lengths will be compared between limbs to determine any longitudinal changes in leg-length discrepancy. Alignment of the lower limb in the coronal plane will be assessed by measuring the mechanical femorotibial axis (MFTA), mechanical lateral distal femoral angle (mLDFA), anatomic lateral distal femoral angle (aLDFA), medial proximal tibial angle and joint line convergence angle (JLCA). Alignment of the lower limb in the sagittal plane will be assessed by measuring flexion and extension of the knee joint.
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Timepoint [11]
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This is reviewed at every associated post-operative clinical (or research) time-point, including intra-operatively and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months post-surgery.
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Secondary outcome [12]
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Active knee extension range
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Assessment method [12]
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This will be measured via the use of a long arm goniometer (with the knee in full extension), 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 malleolus at the ankle).
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Timepoint [12]
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24 months post-surgery
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Secondary outcome [13]
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Maximal isokinetic strength of the hamstring muscle group
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Assessment method [13]
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This will be assessed using an isokinetic dynamometer. 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.
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Timepoint [13]
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24 months post-surgery
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Eligibility
Key inclusion criteria
Study Inclusion Criteria
• The individual is at least 8 years of age and under 18 years of age.
• Knee trauma with signs of an ACL tear on clinical, radiographic and magnetic resonance imaging (MRI) examination.
• Radiological evidence demonstrating open growth plates at the distal femur and proximal tibia.
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Minimum age
8
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Study Exclusion Criteria
• The individual (and parent) is unable or unwilling to sign the Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board.
• ACLR revision procedures.
• Evidence of knee dislocation on clinical, radiographic and magnetic resonance imaging (MRI) examination.
• Symptomatic articular cartilage defect requiring treatment other than debridement.
• Major concomitant procedures such as high tibial osteotomy or other knee ligament reconstructions.
• Varus or valgus malalignment greater than 3 degrees.
• Non-English speaking.
• Known to be pregnant.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed, with allocation at the time of surgery undertaking via contacting the holder of the allocation schedule who will be "off-site".
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be undertaken via a random number generator via an online platform in a 1:1 ratio.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/06/2024
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Actual
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Date of last participant enrolment
Anticipated
1/06/2026
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Actual
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Date of last data collection
Anticipated
1/06/2028
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Actual
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Sample size
Target
44
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Western Australia
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Western Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
318507
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Country [1]
318507
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/04/2022
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Approval date [1]
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08/02/2023
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Ethics approval number [1]
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Summary
Brief summary
This is a prospective randomized controlled trial (RCT) comparing outcomes in paediatric patients undergoing anterior cruciate ligament reconstruction (ACLR) with or without concomitant iliotibial band tenodesis. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period. This will include 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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Peter Annear
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Address
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Perth Children’s Hospital, 15 Hospital Avenue Nedlands, Western Australia, 6009
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Country
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Australia
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Phone
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+61 8 417 492 100
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Jay Ebert
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Address
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School of Human Sciences (Exercise and Sport Science), University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009
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Country
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Australia
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Phone
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+61 8 421 922 402
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Jay Ebert
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Address
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School of Human Sciences (Exercise and Sport Science), University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009
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Country
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Australia
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Phone
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+61 8 421 922 402
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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