None listed
Conditions
Brief summary
Despite a wealth of research examining muscle fat infiltration (MFI) and its relationship with outcomes, the aetiology of its progression is unclear. To date, studies that have tracked the time-course of MFI have not prospectively examined the effect of different treatment modalities 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 tear management over nine months. Muscle quality measures on MRI will be collected at baseline and at 9-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 tear management will be considered for eligibility. 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 treatment commencement dates. During and after treatment, all participants will receive standard care for the rotator cuff, including several usual care orthopaedic consultations. The assessments will be re-administered at a 9-month follow-up appointment with their treating surgeon which will include the same baseline 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 nine post-treatment months regardless of treatment group. Secondly, it is hypothesised that 3D MFI measures will significantly differ between participants with an intact and torn rotator cuff (i.e., surgical vs non-surgical/re-tear).
Interventions
This is a prospective cohort study investigating the effect of time on the progression or regression of rotator cuff muscle fat infiltration (MFI) in rotator cuff tear management. It will measure and test the significance of the change in MFI within a nine-month period in surgical versus non-surgical management of rotator cuff tears.
The study comprises two timepoints of data collection–baseline and 9-month periods after commencement of rotator cuff tear management. All management between these
This is a prospective cohort study investigating the effect of time on the progression or regression of rotator cuff muscle fat infiltration (MFI) in rotator cuff tear management. It will measure and test the significance of the change in MFI within a nine-month period in surgical versus non-surgical management of rotator cuff tears. The study comprises two timepoints of data collection–baseline and 9-month periods after commencement of rotator cuff tear management. 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 post-treatment MRI at the 9-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-, intermediate-weighted 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 9-month post-treatment 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).
Sponsors
Professor James (Jim) Elliott, The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
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.
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
Outcome results
None listed