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Trial registered on ANZCTR


Registration number
ACTRN12623000877684
Ethics application status
Approved
Date submitted
1/08/2023
Date registered
15/08/2023
Date last updated
14/07/2024
Date data sharing statement initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Muscle quality in atraumatic rotator cuff tears.
Scientific title
Investigating the effect of time on the trajectories of muscle fat infiltration following rotator cuff repair in adults with atraumatic rotator cuff tears.
Secondary ID [1] 310269 0
None
Universal Trial Number (UTN)
U1111-1296-0035
Trial acronym
MQR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tear 330955 0
Condition category
Condition code
Injuries and Accidents 327758 327758 0 0
Other injuries and accidents
Musculoskeletal 327856 327856 0 0
Other muscular and skeletal disorders
Surgery 327857 327857 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective cohort study investigating the effect of time on the progression or regression of rotator cuff muscle fat infiltration (MFI) following rotator cuff repair. It will measure and test the significance of the change in MFI within a six-month period in failed versus successful rotator cuff repairs.

The study comprises two timepoints of data collection–baseline and 6-month postoperative periods of rotator cuff repair. All management between these two timepoints will be delivered as usual, best-practice care of the treating orthopaedic surgeons. The amendment to usual care is the addition of questionnaires, formal collection of shoulder assessment data and an additional postoperative MRI at the 6-month period.

The additional MRI will be collected at local radiology clinics by radiographers trained in MR techniques. It is a T1 VIBE Dixon sequence that is added to the normal clinical workflow of either T2- or proton-density-weighted MR images of the shoulder. The additional sequence takes five extra minutes.

Questionnaires will be collected in-person by the participants' treating surgeons. These are questionnaires that proxy measures of function, fear avoidance, negative mood, satisfaction and pain. The additional questionnaires will add ten minutes to the preoperative and 6-month postoperative surgical consultations.

Adherence to the additional assessments will be monitored by a Patient Data Form which collected outcome data and dates of visits in an anonymised form, where participants are provided a participant number (e.g., ID001).
Intervention code [1] 326645 0
Diagnosis / Prognosis
Intervention code [2] 326646 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335557 0
Muscle fat infiltration (%) of rotator cuff muscles as measured by T1 VIBE Dixon MR images and segmented by a multi-muscle deep learning model
Timepoint [1] 335557 0
Preoperative, 6-month postoperative
Primary outcome [2] 335558 0
Rotator cuff (re-)tear incidence as confirmed by a radiologist report of the six-month follow-up MRI of the shoulder
Timepoint [2] 335558 0
6-month postoperative
Secondary outcome [1] 424942 0
Rotator cuff tear characteristics as confirmed by a radiologist report of the six-month follow-up MRI of the shoulder
Timepoint [1] 424942 0
Preoperative, 6-month postoperative
Secondary outcome [2] 424944 0
American Shoulder and Elbow Surgeons Score (shoulder pain, activities of daily living, range of motion, strength)
Timepoint [2] 424944 0
Preoperative, 6-month postoperative
Secondary outcome [3] 424945 0
Adverse events as determined by the treating surgeon on clinical examination or review of electronic medical records, recorded on a Patient Data Form
Timepoint [3] 424945 0
At any time in the 6-month postoperative period
Secondary outcome [4] 424946 0
Patient Health Questionnaire 9-item (negative mood)
Timepoint [4] 424946 0
Preoperative, 6-month postoperative
Secondary outcome [5] 424947 0
Tampa Scale of Kinesiophobia 11-item (fear avoidance of movement)
Timepoint [5] 424947 0
Preoperative, 6-month postoperative
Secondary outcome [6] 424948 0
Muscle volume as measured on T1 VIBE Dixon MRI and segmented by a multi-muscle deep learning model
Timepoint [6] 424948 0
Preoperative, 6-month postoperative
Secondary outcome [7] 424949 0
Satisfaction (VAS)
Timepoint [7] 424949 0
Preoperative, 6-month postoperative
Secondary outcome [8] 424950 0
Pain (VAS)
Timepoint [8] 424950 0
Preoperative, 6-month postoperative
Secondary outcome [9] 425541 0
Muscle fat infiltration (%) of surrounding glenohumeral muscles (i.e., deltoid, trapezius, teres major, triceps brachii) as measured by T1 VIBE Dixon MR images and segmented by a multi-muscle deep learning model
Timepoint [9] 425541 0
Preoperative, 6-month postoperative

Eligibility
Key inclusion criteria
(1) between 50 and 80 years of age;
(2) have current complaints of pain limited to the shoulder;
(3) symptoms for at least the past three months without acute trauma;
(4) rotator cuff tear on magnetic resonance imaging (MRI); (5) no other internal joint disorders (arthritis, capsulitis);
(6) eligible and able to consent to rotator cuff tear treatment.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) history of trauma related to shoulder symptoms;
(2) presence of rheumatological disease;
(3) presence of neurological injury;
(4) contraindications to MRI;
(5) previous history of shoulder surgery; (6) current shoulder fracture, tumour, or infection

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size will be calculated a priori. Alpha level will be set to 0.05 and the desired power will be defined as 80%. The primary outcome measure (change in muscle fat infiltration (MFI) between pre- and postoperative periods) has demonstrated a mean difference of 1.6 (SD, 4.72) which corresponds to a standardised mean difference of 0.339. Assuming a moderate correlation between pre- and post-operative MFI measurements, a formal power analysis indicated a minimum of 71 subjects be recruited, with a 10% drop-out rate adjustment bringing the sample size to 79. This sample size is adequate to estimate the proportion of post-operative retears with a margin of 10% error based on a prior estimate of 20% retear percentage. The sample size was adjusted for multiplicity due to correlated primary outcomes. For a moderate to strong correlation between change in MFI (%) and retear incidence, the sample size was multiplied by 1.35, setting the final sample size as 107.

Descriptive statistics will be reported as means and standard deviations for continuous variables and as counts and percentages for categorical variables for preoperative variables and postoperative results. Demographic data from patients will be compared using Students t tests (continuous parameters) Mann-Whitney U tests (ordinal parameters) and Chi squared analysis (counts). P values <0.05 will be considered as statistically significant. A Bonferroni correction for multiple tests will be performed.

Outcome data will be analysed by univariate and multivariate mixed modelling to correct for patient demographics, site of surgery, and time of surgery. Correlations between outcomes will be reported using Pearson’s (continuous variables) or Spearman’s (interval or ordinal variables) correlation coefficients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/03/2024
Actual
1/04/2024
Date of last participant enrolment
Anticipated
24/03/2025
Actual
Date of last data collection
Anticipated
29/09/2025
Actual
Sample size
Target
107
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25303 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 25304 0
Mater Sydney - North Sydney
Recruitment hospital [3] 25305 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 40977 0
2064 - Artarmon
Recruitment postcode(s) [2] 40979 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [3] 40980 0
2065 - St Leonards
Recruitment postcode(s) [4] 40981 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 314476 0
University
Name [1] 314476 0
Professor James (Jim) Elliott, The University of Sydney
Country [1] 314476 0
Australia
Funding source category [2] 316148 0
Charities/Societies/Foundations
Name [2] 316148 0
NORTH Foundation
Country [2] 316148 0
Australia
Primary sponsor type
University
Name
Professor James (Jim) Elliott, The University of Sydney
Address
Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064
Country
Australia
Secondary sponsor category [1] 316427 0
None
Name [1] 316427 0
Address [1] 316427 0
Country [1] 316427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313527 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313527 0
Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064
Ethics committee country [1] 313527 0
Australia
Date submitted for ethics approval [1] 313527 0
29/07/2023
Approval date [1] 313527 0
11/03/2024
Ethics approval number [1] 313527 0

Summary
Brief summary
Despite a wealth of research examining muscle fat infiltration (MFI) and its relationship with tendon re-tear, the evidence base for the correlation’s direction and strength are unclear.

To date, studies that have tracked the time-course of MFI have not prospectively examined the effect of surgery on its trajectory. By extension, prior works have not investigated the relationships of structural or functional outcomes with three-dimensional MFI. Given that subjective two-dimensional evaluations of MFI have demonstrated poor inter-rater reliability for muscle quality, there is reason to believe that our tentative confidence in preoperative MFI’s prognostic power for surgical outcomes is erroneously underpinned by baseline measures that lack reliability and validity. In fact, there have been conflicting results between qualitative and semi-quantitative measures.

This is a prospective cohort study that aims to track clinically meaningful changes to image-derived features of rotator cuff repair over six months. Muscle quality measures on MRI will be collected preoperatively and at 6-months along with biopyschosocial measures and patient reported outcomes of pain satisfaction, function and activities of daily living.

All consecutive patients indicated for rotator cuff repair will be considered eligible. After reading the information sheet and signing the consent form, they will be invited to enrol. Baseline characteristics of age, sex, hand dominance, medications, body mass index, prior surgeries, alcohol/tobacco use, and relevant comorbidities will be recorded along with tear characteristics, pre-operative 3 x Patient Reported Outcome Measures (PROMs) and 2 x VAS scores: the American Shoulder and Elbow Society (ASES) Score – Patient, the Patient Health Questionnaire 9-item (PHQ-9), the Tampa Scale of Kinesiophobia 11-item (TSK-11), Visual Anolog Scale (VAS) Pain, VAS Satisfaction.

Enrolled participants will be referred for a preoperative MRI shoulder scan which will be collected prior to their operation dates. During and after surgery, all participants will receive standard care for the rotator cuff, including several perioperative orthopaedic consultations. The assessments will be re-administered at a 6-month follow-up appointment with their treating surgeon which will include the same preoperative measures of range of motion and scores from the 3 x PROMs and 2 x VAS. Finally, participants will be asked to undertake a follow-up MRI scan of the shoulder to evaluate muscle fat infiltration, muscle volume and tear characteristics.

There are two primary outcome measures. Firstly, it is hypothesised that MFI of the rotator cuff will significantly change within the first six postoperative months. Secondly, it is hypothesised that 3D MFI measures will significantly differ between participants with an intact and re-torn rotator cuff.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128454 0
Prof James Elliott
Address 128454 0
Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064
Country 128454 0
Australia
Phone 128454 0
+61 426537623
Fax 128454 0
Email 128454 0
[email protected]
Contact person for public queries
Name 128455 0
Woo Shik (Brian) Kim
Address 128455 0
Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064
Country 128455 0
Australia
Phone 128455 0
+61 450802407
Fax 128455 0
Email 128455 0
[email protected]
Contact person for scientific queries
Name 128456 0
Woo Shik (Brian) Kim
Address 128456 0
Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064
Country 128456 0
Australia
Phone 128456 0
+61 450802407
Fax 128456 0
Email 128456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Completely de-identified individual patient data for MRI, demographic and biopyschosocial measures will be available if underlying the published results.
When will data be available (start and end dates)?
De-identified data will be immediately available following publication with no end date.
Available to whom?
Researchers who communicate a reasonable request with a detailed study protocol presenting ethical considerations of secondary data use will be able to access the data. These communications will be reviewed on a case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
De-identified data may be used for any purpose that supports the aims of a rigorously-crafted proposal as determined by the Primary Sponsor and the original research project team.
How or where can data be obtained?
Access will be subject to approvals by the Co-ordinating Principal Investigator Prof Jim Elliott ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19853Study protocol  [email protected] A study protocol will be published in an open-acce... [More Details]



Results publications and other study-related documents

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