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Trial registered on ANZCTR


Registration number
ACTRN12619000578101p
Ethics application status
Not yet submitted
Date submitted
5/04/2019
Date registered
12/04/2019
Date last updated
12/04/2019
Date data sharing statement initially provided
12/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Evaluation of Meniscal Repair in Paediatric Patients
Scientific title
A Prospective Evaluation of Arthroscopic All-Inside Meniscal Repair in Paediatric Patients
Secondary ID [1] 297902 0
None
Universal Trial Number (UTN)
U1111-1231-2363
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee meniscal tears 312286 0
Condition category
Condition code
Surgery 310831 310831 0 0
Surgical techniques
Musculoskeletal 310899 310899 0 0
Other muscular and skeletal disorders
Injuries and Accidents 310900 310900 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who fulfill the inclusion criteria and are undergoing orthopaedic surgery at the Perth Children's Hospital for their symptomatic knee meniscal tears (with or without concomitant pathology which will be addressed at the time of surgery if required), will be invited to participate in this study. Patients as part of this prospective review are already undergoing knee surgery to address their symptomatic meniscal tear, as per the routine clinical pathway. This study has been designed as a robust pre- and post-operative clinical review of this patient cohort undergoing surgery. Patients will be reviewed over a 24-month post-operative period, and will attend for these clinical reviews specifically pre-surgery, as well as 6 weeks and 3, 6, 12 and 24 months post-surgery.
Intervention code [1] 314123 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319667 0
Limb Symmetry Index (LSI) of the single hop for distance (cm) - this test requires a measurement tape. The patient begins on one limb in an upright position. The objective is to hop off one limb as far as possible (forwards), landing on the same limb in a controlled manner.
Timepoint [1] 319667 0
24 months post-surgery
Secondary outcome [1] 369084 0
Limb Symmetry Index (LSI) of the triple hop for distance (cm) - this test requires a measurement tape. The patient begins on one limb in an upright position. The objective is to hop off one limb for three consecutive hops (all on the same limb, and without pausing in between each hop) as far as possible (forwards), landing on the same limb in a controlled manner.
Timepoint [1] 369084 0
24 months post-surgery
Secondary outcome [2] 369085 0
Limb Symmetry Index (LSI) of the triple crossover hop for distance (cm) - this test requires a measurement tape and 15cm width mat. The patient begins on one limb in an upright position. The objective is to hop off one limb for three consecutive hops (all on the same limb, and without pausing in between each hop) as far as possible (forwards), landing on the same limb in a controlled manner. However, in this test patients must hop back and forth over a 15cm width mat for each of the three hops. The test is considered successful if the patient lands in a controlled manner on the third hop, though does not touch the mat on each of the three hops back and forth.
Timepoint [2] 369085 0
24 months post-surgery
Secondary outcome [3] 369086 0
Active knee range of motion - this will be measured with the patient lying supine using a hand held goniometer, creating an angle made by three anatomical landmarks; the greater trochanter of the femur at the hip, the lateral femoral condyle at the knee and the lateral malleolus at the ankle.
Timepoint [3] 369086 0
24 months post-surgery
Secondary outcome [4] 369087 0
Visual Analogue Pain Scale (VAS)
Timepoint [4] 369087 0
24 months post-surgery
Secondary outcome [5] 369088 0
International Knee Documentation Committee (IKDC) Subjective Knee Form
Timepoint [5] 369088 0
24 months post-surgery
Secondary outcome [6] 369089 0
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [6] 369089 0
24 months post-surgery
Secondary outcome [7] 369090 0
Lysholm Knee Score
Timepoint [7] 369090 0
24 months post-surgery
Secondary outcome [8] 369091 0
Tegner Activity Scale (TAS)
Timepoint [8] 369091 0
24 months post-surgery
Secondary outcome [9] 369092 0
Patient Satisfaction (Overall Outcome) - this will evaluate satisfaction with the surgery overall. A Likert response scale will be employed with descriptors Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied.
Timepoint [9] 369092 0
24 months post-surgery
Secondary outcome [10] 369378 0
Patient Satisfaction (Pain) - this will evaluate satisfaction with the surgery to relieve knee pain. A Likert response scale will be employed with descriptors Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied.
Timepoint [10] 369378 0
24 months post-surgery
Secondary outcome [11] 369379 0
Patient Satisfaction (ADLs) - this will evaluate satisfaction with the surgery to improve the ability to undertake daily and/or work activities. A Likert response scale will be employed with descriptors Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied.
Timepoint [11] 369379 0
24 months post-surgery
Secondary outcome [12] 369380 0
Patient Satisfaction (Recreation) - this will evaluate satisfaction with the surgery to improve the ability to return to recreational activities (including walking, swimming, cycling, golf, dancing). A Likert response scale will be employed with descriptors Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied.
Timepoint [12] 369380 0
24 months post-surgery
Secondary outcome [13] 369381 0
Patient Satisfaction (Sport) - this will evaluate satisfaction with the surgery to improve the ability to participate in sport (including sports such as tennis, netball, soccer and football). A Likert response scale will be employed with descriptors Very Satisfied, Somewhat Satisfied, Somewhat Dissatisfied and Very Dissatisfied.
Timepoint [13] 369381 0
24 months post-surgery

Eligibility
Key inclusion criteria
Patients will already be undergoing surgery for their symptomatic knee meniscal tear.

Therefore, outside of the routine criteria for surgery, study inclusion criteria are:

1. The individual is between the ages of 8 and 16 years.
2. The individual clinically qualifies for meniscal repair surgery based on clinical examination and MRI.
3. Multiple meniscal injuries are present.
4. The meniscal repair is combined with another knee surgery (or surgeries), such as ligament reconstruction
Minimum age
8 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will already be undergoing surgery for their symptomatic knee meniscal tear.

Therefore, outside of the routine criteria for surgery, study exclusion criteria are:

1. 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.
2, The individual is classified as morbidly obese (>40 BMI).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Study Sample Size

For this study, a priori sample size power calculation has been determined employing G-Power (Dusseldorf, Germany). The primary outcome variable is the Limb Symmetry Index (LSI) of the single hop for distance (cm) at 24 months post-surgery. The LSI is a measure of the operated limb as a percentage of the non-operated limb. An LSI <90% has been regarded as clinically unsatisfactory for a variety of strength and functional tests, including single limb hop capacity. We would expect that the LSI in the single limb hop test for distance to be 100% (irrespective of limb dominance), and for the current study accept side-to-side equivalence if the LSI in single limb hop capacity (as per the single hop for distance test – cm) of >90%, as per current clinical recommendations of functional limb restoration after lower limb surgery. Therefore, using these values (i.e. a non-inferiority margin of 10%) and a SD of 15%, 26 patients will be required at alpha 0.05 with 95% power, to test the primary hypothesis that non-inferiority will be observed (in the single hop test for distance) in paediatric patients undergoing ‘all-inside’ meniscal repair surgery for symptomatic meniscal tears at 24 months post-surgery. Therefore, we seek to recruit and assess 30 patients (i.e. an additional 15% to allow for attrition over the 24 month assessment period).

Planned Data and Statistical 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. 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 active knee ROM and functional hop capacity (both absolute scores for the operated and non-operated limbs, as well as LSIs). ANOVA will also be employed to evaluate differences between the operated and non-operated limbs in these tests. LSIs will be calculated for the single limb hop 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 <90% and =90% (as per clinical recommendations of unsatisfactory and satisfactory performance, respectively). 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 will be presented. The status of meniscal healing as demonstrated on MRI (6 and 12 months) will be reported, though a definitive scoring tool may be employed depending on availability at the time. Where appropriate, statistical analysis will be performed using SPSS software (SPSS, Version 23.0, SPSS Inc., USA), while statistical significance was determined at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 13565 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 26210 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 302420 0
University
Name [1] 302420 0
University of Western Australia
Address [1] 302420 0
35 Stirling Highway, Crawley, Western Australia, 6009
Country [1] 302420 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] 302318 0
None
Name [1] 302318 0
Address [1] 302318 0
Country [1] 302318 0
Other collaborator category [1] 280630 0
University
Name [1] 280630 0
University of Western Australia
Address [1] 280630 0
35 Stirling Highway, Crawley, Western Australia, 6009
Country [1] 280630 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303089 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 303089 0
Perth Children Hospital
Level 5, Office 5E
15 Hospital Avenue, Nedlands
Locked Bag 2010, Nedlands WA 6909
Ethics committee country [1] 303089 0
Australia
Date submitted for ethics approval [1] 303089 0
15/04/2019
Approval date [1] 303089 0
Ethics approval number [1] 303089 0

Summary
Brief summary
This is a prospective study seeking to investigate the post-operative clinical and radiographic outcomes of meniscal repair surgery in the knee in paediatric patients, with or without concomitant knee surgery if indicated. Patient outcomes will be collected over a 24 month post-operative period, and will include a range of subjective and functional outcomes, radiographic measures and patient satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92434 0
Dr Jay Ebert
Address 92434 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway
Crawley, Western Australia, 6009
Country 92434 0
Australia
Phone 92434 0
+61 8 9386 9961
Fax 92434 0
Email 92434 0
jay.ebert@uwa.edu.au
Contact person for public queries
Name 92435 0
Dr Jay Ebert
Address 92435 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway
Crawley, Western Australia, 6009
Country 92435 0
Australia
Phone 92435 0
+61 8 9386 9961
Fax 92435 0
Email 92435 0
jay.ebert@uwa.edu.au
Contact person for scientific queries
Name 92436 0
Dr Jay Ebert
Address 92436 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway
Crawley, Western Australia, 6009
Country 92436 0
Australia
Phone 92436 0
+61 8 9386 9961
Fax 92436 0
Email 92436 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
There is no requirement for this.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1801 0
Study protocol
Citation [1] 1801 0
Link [1] 1801 0
Email [1] 1801 0
Other [1] 1801 0
Summary results
No Results