Trial Review

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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
Scientific title
A randomized controlled study comparing anterior cruciate ligament reconstruction with or without additional iliotibial band tenodesis in paediatric patients
Secondary ID [1] 311978 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior cruciate ligament tears 333587 0
Condition category
Condition code
Musculoskeletal 330267 330267 0 0
Other muscular and skeletal disorders
Surgery 330269 330269 0 0
Surgical techniques
Injuries and Accidents 330271 330271 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 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.
Intervention code [1] 328436 0
Treatment: Surgery
Intervention code [2] 328480 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 338010 0
Anteroposterior knee laxity
Timepoint [1] 338010 0
6 months post-surgery
Secondary outcome [1] 434107 0
Knee Pain
Timepoint [1] 434107 0
24 months post-surgery
Secondary outcome [2] 434108 0
A composite outcome score that includes individual items of knee pain, symptoms and functional capacity
Timepoint [2] 434108 0
24 months post-surgery
Secondary outcome [3] 434109 0
A composite outcome score that includes individual items of knee pain, symptoms and recreational and sports capacity
Timepoint [3] 434109 0
24 months post-surgery
Secondary outcome [4] 434110 0
Activity Level
Timepoint [4] 434110 0
24 months post-surgery
Secondary outcome [5] 434111 0
Active knee flexion range
Timepoint [5] 434111 0
24 months post-surgery
Secondary outcome [6] 434112 0
Maximal isokinetic strength of the quadriceps muscle group
Timepoint [6] 434112 0
24 months post-surgery
Secondary outcome [7] 434113 0
Functional single-limb hop capacity
Timepoint [7] 434113 0
24 months post-surgery
Secondary outcome [8] 434114 0
Surgical Complications
Timepoint [8] 434114 0
Intra-operatively
Secondary outcome [9] 434115 0
Knee re-injuries (and associated re-operations)
Timepoint [9] 434115 0
24 months post-surgery
Secondary outcome [10] 434116 0
Adverse Events
Timepoint [10] 434116 0
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.
Secondary outcome [11] 434117 0
Lower limb deformity and/or growth arrest
Timepoint [11] 434117 0
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.
Secondary outcome [12] 434417 0
Active knee extension range
Timepoint [12] 434417 0
24 months post-surgery
Secondary outcome [13] 434418 0
Maximal isokinetic strength of the hamstring muscle group
Timepoint [13] 434418 0
24 months post-surgery

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.
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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".
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.
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316322 0
University
Name [1] 316322 0
University of Western Australia
Country [1] 316322 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 318507 0
None
Name [1] 318507 0
Address [1] 318507 0
Country [1] 318507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315135 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315135 0
Ethics committee country [1] 315135 0
Australia
Date submitted for ethics approval [1] 315135 0
01/04/2022
Approval date [1] 315135 0
08/02/2023
Ethics approval number [1] 315135 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133778 0
Mr Peter Annear
Address 133778 0
Perth Children’s Hospital, 15 Hospital Avenue Nedlands, Western Australia, 6009
Country 133778 0
Australia
Phone 133778 0
+61 8 417 492 100
Fax 133778 0
Email 133778 0
peter.annear@health.wa.gov.au
Contact person for public queries
Name 133779 0
Dr Jay Ebert
Address 133779 0
School of Human Sciences (Exercise and Sport Science), University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009
Country 133779 0
Australia
Phone 133779 0
+61 8 421 922 402
Fax 133779 0
Email 133779 0
jay.ebert@uwa.edu.au
Contact person for scientific queries
Name 133780 0
Dr Jay Ebert
Address 133780 0
School of Human Sciences (Exercise and Sport Science), University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009
Country 133780 0
Australia
Phone 133780 0
+61 8 421 922 402
Fax 133780 0
Email 133780 0
jay.ebert@uwa.edu.au

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
No additional documents have been identified.