Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001556730p
Ethics application status
Submitted, not yet approved
Date submitted
9/11/2022
Date registered
16/12/2022
Date last updated
16/12/2022
Date data sharing statement initially provided
16/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Operative vs Non-operative Management of Posterior- medial Meniscal Root Tears: A Randomized Multicenter International Trial
Scientific title
Efficacy of Operative vs Non-operative Management of Posterior- medial Meniscal Root Tears: A Randomized Multicenter International Trial
Secondary ID [1] 308341 0
Nil known
Universal Trial Number (UTN)
U1111-1284-6882
Trial acronym
The ROOT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medial meniscal posterior root tears 328131 0
Condition category
Condition code
Musculoskeletal 325181 325181 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is medial meniscal posterior root repair. This procedure will be performed once by an experienced orthopaedic knee surgeon in the operating room of a hospital. This procedure involves repairing the torn posterior root of the medial meniscus with sutures pulled down through a bone tunnel. The procedure takes approximately 45 minutes to one hour.
Intervention code [1] 324788 0
Treatment: Surgery
Comparator / control treatment
The control treatment is optimised non-operative treatment. This will consist of a period of 6 weeks non weight bearing, analgesics and physical therapy.
The treatment will be coordinated by the treating doctor and delivered by the patient's physiotherapist.
Analgesic treatment will consist of anti-inflammatory medication daily. This could be Meloxicam 15 mg daily orally or Diclofenac 50mg three times daily orally depending on patient tolerance, and will be monitored by patient self-reporting.
Physiotherapy will consist of 2 supervised sessions per week of 30-45 minutes, at the physiotherapist office or patient home, with a focus on exercises to maintain strength and stability around the knee joint. These sessions will be one-on-one and administered by a qualified physiotherapist.
Physiotherapy attendance records will be monitored to assess adherence.
Control group
Active

Outcomes
Primary outcome [1] 333013 0
Patient reported pain scores.

Pain scores will be assessed using the visual analog scale (VAS) for pain. The scale is composed of a vertical or horizontal line, typically 10 cm in length, with anchoring descriptions of “0 – no pain” and “10 – worst pain imaginable.”
Timepoint [1] 333013 0
12 months following commencement of treatment, be that operative or non-operative.

This will also be assessed at baseline, 3 and 6 months post injury or surgery.
Secondary outcome [1] 415534 0
We will measure symptoms of osteoarthritis of the knee using the Western Ontario Meniscal Evaluation Tool (WOMET).
Timepoint [1] 415534 0
12 months

These will also be assessed at baseline, 3, and 6 months post injury or surgery.
Secondary outcome [2] 415535 0
Range of motion of the knee using a goniometer.
Timepoint [2] 415535 0
12 months

This will also be assessed at baseline, 3 and 6 months post injury or surgery.
Secondary outcome [3] 415536 0
Meniscal extrusion will be assessed using MRI.
Timepoint [3] 415536 0
12 months following injury or surgery..
Secondary outcome [4] 416487 0
We will measure region-specific quality of life using the Knee Osteoarthritis and Outcomes Score (KOOS)
Timepoint [4] 416487 0

These will be assessed at baseline, 3, 6 and 12 months post injury or surgery.
Secondary outcome [5] 416488 0
We will measure quality-adjusted life years (QALYs) using the European Quality of Life Scale (EuroQoL).
Timepoint [5] 416488 0
These will be assessed at baseline, 3, 6 and 12 months post injury or surgery.
Secondary outcome [6] 416489 0
Overall knee function will be assessed using The Lysholm knee score.
Timepoint [6] 416489 0
These will be assessed at baseline, 3, 6 and 12 months post injury or surgery
Secondary outcome [7] 416490 0
Limb alignment will be assessed using plain radiographs.
Timepoint [7] 416490 0
At baseline, 3, 6 and 12 months post injury or surgery.
Secondary outcome [8] 416886 0
Progression of osteoarthritis will be assessed on plain radiographs.
Timepoint [8] 416886 0
At baseline and 12 months post injury or surgery.

Eligibility
Key inclusion criteria
MRI verified isolated medial meniscal posterior root tear
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Concurrent ligamentous knee pathology requiring surgical intervention (i.e. anterior cruciate ligament tear, posterior cruciate ligament tear, posterolateral corner injury, high-grade medial collateral ligament tear),
(2) Preoperative Kellgren-Lawrence grade of 3 or 4
(3) Inability to complete outcome questionnaires or comply with required postoperative imaging or MRI requirements, or
(4) Medical contraindications to surgery or physical therapy. There will be no exclusion criteria regarding body mass index (BMI) or mechanical alignment, however they will be stratified in groups for further analysis (BMI less and over 35 and varus alignment below and over 3º of varus.
(5) Pregnancy

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)
Sealed opaque envelopes
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
Sample size estimates for this investigation were based on data from similar randomized controlled trials comparing arthroscopic partial meniscectomy vs. placebo surgery. In the described sample size calculations, subjects with knee osteoarthritis (OA) had reported a post-exercise pain response standard deviation (SD) of 31.4 mm. (38, 53) Similarly, in the same population, the standard deviation of Lysholm and WOMET scores was 21.1 and 24.5, respectively. Using these data, a sample size of 108 (54 per group) would be required for 80% power to detect differences of 20 mm, 11.5, and 15.5 points between groups, in the VAS pain, Lysholm, and WOMET scores, respectively, based on a two-side comparison and type I error of 5%. Assuming an approximately 20% attrition rate, and additional allowances made for screen failures at the time of surgery and uneven distribution among study sites, we will seek to enroll 70 subjects per group for a total of 140 consented subjects.

Statistical analyses will include univariate descriptive statistics and bivariate analyses to identify outliers, floor and ceiling effects, and to verify random distribution of covariates (age, sex, BMI, comorbidities, etc.) and identify any associations between covariates and outcome variables. The mean and standard error (WOMET, KOOS, EuroQoL) for each group will be calculated at each time point, with additional calculation of the mean between-group difference with 95% confidence interval performed at 3, 6 and 12 months postoperatively. Radiographic parameters, including medial joint space measurements at 25, 50, and 75% of the width of the medial plateau width will be measured at 3, 6, and 12 months. MRI quantitative data will include absolute meniscal extrusion measured on the coronal section through the center of the tibiofemoral compartment as previously described.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2023
Actual
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23524 0
The Avenue Private Hospital - Windsor
Recruitment postcode(s) [1] 38937 0
3181 - Windsor
Recruitment outside Australia
Country [1] 25114 0
United States of America
State/province [1] 25114 0
Ilinois

Funding & Sponsors
Funding source category [1] 312584 0
Charities/Societies/Foundations
Name [1] 312584 0
Melbourne Orthopaedic Group Research Trust
Country [1] 312584 0
Australia
Primary sponsor type
University
Name
Rush University
Address
1653 W Congress Parkway #12
Chicago, IL 60612
Country
United States of America
Secondary sponsor category [1] 314193 0
None
Name [1] 314193 0
Address [1] 314193 0
Country [1] 314193 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311910 0
Ramsay Health Care NSW / VIC Human Research Ethics Committee
Ethics committee address [1] 311910 0
Ethics committee country [1] 311910 0
Australia
Date submitted for ethics approval [1] 311910 0
10/11/2022
Approval date [1] 311910 0
Ethics approval number [1] 311910 0

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

Contacts
Principal investigator
Name 122810 0
Dr Jorge Chala
Address 122810 0
Rush University Medical Centre
1611 W Harrison St, Chicago, IL 60622
Country 122810 0
United States of America
Phone 122810 0
+13124322390
Fax 122810 0
Email 122810 0
[email protected]
Contact person for public queries
Name 122811 0
Timothy Lording
Address 122811 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 122811 0
Australia
Phone 122811 0
+61 3 95739694
Fax 122811 0
Email 122811 0
[email protected]
Contact person for scientific queries
Name 122812 0
Timothy Lording
Address 122812 0
Melbourne Orthopaedic Group
33 The Avenue
Windsor VIC 3181
Country 122812 0
Australia
Phone 122812 0
+61 3 95739694
Fax 122812 0
Email 122812 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
No additional documents have been identified.