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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]

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

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

Other muscular and skeletal disorders

Surgery

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]

Diagnosis / Prognosis

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Preoperative, 6-month postoperative

Primary outcome [2]

Rotator cuff (re-)tear incidence as confirmed by a radiologist report of the six-month follow-up MRI of the shoulder

Timepoint [2]

6-month postoperative

Secondary outcome [1]

Rotator cuff tear characteristics as confirmed by a radiologist report of the six-month follow-up MRI of the shoulder

Timepoint [1]

Preoperative, 6-month postoperative

Secondary outcome [2]

American Shoulder and Elbow Surgeons Score (shoulder pain, activities of daily living, range of motion, strength)

Timepoint [2]

Preoperative, 6-month postoperative

Secondary outcome [3]

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]

At any time in the 6-month postoperative period

Secondary outcome [4]

Patient Health Questionnaire 9-item (negative mood)

Timepoint [4]

Preoperative, 6-month postoperative

Secondary outcome [5]

Tampa Scale of Kinesiophobia 11-item (fear avoidance of movement)

Timepoint [5]

Preoperative, 6-month postoperative

Secondary outcome [6]

Muscle volume as measured on T1 VIBE Dixon MRI and segmented by a multi-muscle deep learning model

Timepoint [6]

Preoperative, 6-month postoperative

Secondary outcome [7]

Satisfaction (VAS)

Timepoint [7]

Preoperative, 6-month postoperative

Secondary outcome [8]

Pain (VAS)

Timepoint [8]

Preoperative, 6-month postoperative

Secondary outcome [9]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Mater Sydney - North Sydney

Recruitment hospital [3]

North Shore Private Hospital - St Leonards

Recruitment postcode(s) [1]

2064 - Artarmon

Recruitment postcode(s) [2]

2065 - Royal North Shore Hospital

Recruitment postcode(s) [3]

2065 - St Leonards

Recruitment postcode(s) [4]

2060 - North Sydney

Funding & Sponsors

Funding source category [1]

University

Name [1]

Professor James (Jim) Elliott, The University of Sydney

Address [1]

Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

NORTH Foundation

Address [2]

Level 14 - Kolling Institute, Royal North Shore Hospital, St Leonards NSW 2065

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/07/2023

Approval date [1]

11/03/2024

Ethics approval number [1]

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

Prof James Elliott

Address

Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064

Country

Australia

Phone

+61 426537623

Fax

[email protected]

Contact person for public queries

Name

Woo Shik (Brian) Kim

Address

Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064

Country

Australia

Phone

+61 450802407

Fax

[email protected]

Contact person for scientific queries

Name

Woo Shik (Brian) Kim

Address

Kolling Institute - Level 13, 10 Westbourne St, St Leonards, NSW 2064

Country

Australia

Phone

+61 450802407

Fax

[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.	Type	Citation	Link	Email	Other Details	Attachment
19853	Study 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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Trial Review

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