Rotator Cuff Tears
Conditions
Keywords
rotator cuff repair, subacromial spacer, older adults
Brief summary
The purpose of this pilot study is to assess the feasibility of a full randomized trial design.
Detailed description
The feasibility objectives are: 1. Recruitment 1. To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent. 2. To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears. 2. Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups. Clinical objectives for observational purposes only are as follows: 1. Patient reported and clinical outcomes. 2. Number of failures in each group (defined as additional surgery and/or having \<12% improvement in SANE score from baseline).
Interventions
PROCEDURESubacromial spacer implantation
A biodegradable balloon implanted arthroscopically between the acromion and humeral head with tenotomy of long head of biceps.
PROCEDURERotator cuff repair
Rotator cuff repair with tenotomy of long head of biceps.
Sponsors
Panam Clinic
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will be blinded to their group allocation. This is possible because the incision and rehabilitation processes are consistent between groups. It is not possible for the treating surgeon to be blinded to group allocation, therefore a research team member (athletic or physical therapist) will remain blinded to group allocation and conduct all study related assessments as well as administer the patient-reported questionnaires. This will be maintained by the participant not removing their shirt during the study assessment. Patients will not be informed of which procedure they will undergo until the study is complete.
Intervention model description
This a double-blind (patient and assessor), parallel, 1:1 multicentre randomized pilot study comparing patients 70 years and older randomized to SBS or RCR. 32 participants from eight orthopaedic surgeons at four sites will be recruited over a one-year period. Randomization will be generated using a web-based system pre-operatively and stratified to ensure 8 medium/large tears and 8 massive tears are allocated to each group.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 70 years of age or older * clinical and radiological diagnosis of a full thickness supraspinatus (or larger) RC tear \>2cm or more than 1 full tendon * ongoing symptoms after 3 months of physiotherapy * a tendon amenable to partial or complete repair (as determined by pre-operative MRI) * absence glenohumeral arthritis (Hamada \< 3) * absence of neoplastic diseases at treated site
Exclusion criteria
* previous surgery or pseudoparalysis on study shoulder * complete subscapularis deficiency * external rotation lag signs * avascular necrosis * post-infectious arthritis * proximal humerus fracture * inflammatory arithritis * axillary nerve palsy * concomitant tendon transfer * neuromuscular disorder * unable to speak/read English Intra-operative Exclusion: -tendon is NOT amenable to partial or complete repair
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study feasibility - randomized | 1 year | Percentage of patients randomized |
| Study feasibility - recruitment | 1 year | Number of screened patients and proportion that are deemed eligible that consent |
| Study feasibility - surgery | 1 year | Consensus among surgeon co-investigators regarding the standardized peri-operative orders and surgical techniques. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Score | Baseline, pre-operative | The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant & Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome. |
| ASES Score | Baseline, pre-operative | The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America. |
| Isometric Strength | Baseline, pre-operative | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation. |
| Range of Motion | Baseline, pre-operative | For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees. |
| EQ5D-3L | Baseline, pre-operative | The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive. |
| SANE Score | Baseline, pre-operative | The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)? |
Contacts
Primary ContactSheila McRae, PhD
Backup ContactBrenna Cyr, BKin
Outcome results
None listed