2.1 Shoulder - Rotator Cuff

Search Terms

(rotator OR subacromial) AND (cuff OR tendon) AND (tear OR tendinopathy OR impingement OR syndrome) AND (incidence OR prevalence OR epidemiolog* OR repair OR treatment OR release) AND (outcomes OR pain OR function)

2.1.2 Definition and epidemiology

Rotator cuff pathologies in the context of the Geelong Orthopaedics registry includes the following:

• Tendinopathy, defined as reduced loading capacity of a tendon associated with pain of one or more of the four tendons that form the rotator cuff (Mallows et al. 2016).
• Impingement of the cuff within the subacromial space characterised by shoulder pain during abduction of the arm between 60° and 120° (Hermans et al. 2013).
• Full or partial thickness tears of any of the rotator cuff tendons defined as a disruption of the fibres of the tendon attaching the rotator cuff muscle to the humeral head such that it ceases to be continuous (Lin et al. 2016; Deprés-Tremblay et al. 2016). Tears can be classified based on location and severity, such as the Lafosse classification of subscapularis tears (Saltzman et al. 2017):
  • Grade I: partial tear of the deep fibres at insertion
  • Grade II: complete tear of the superior one-third
  • Grade III: complete tear of the superior two-thirds
  • Grade IV: complete tear with retraction but no subluxation of the humeral head
  • Grade V: complete tear with retraction and anterior subluxation of the humeral head
• Loss of rotator cuff function can lead to a complex pattern of glenohumeral degeneration (rotator cuff tear arthropathy) (Eajazi et al. 2015).

The prevalence of symptomatic rotator cuff pathology increases with age, occurring in about 2.8% of those >30 years old and in 15% of those >70 years old (Hermans et al. 2013), with rotator cuff tendinopathy the most frequent diagnosis (St-Pierre et al. 2016). The prevalence of tears in the general population has been estimated to range from 0% (20s) to 11% (50s), increasing to 37% (80s) with age, with 65% being asymptomatic (Minagawa et al. 2013). Biceps disorders are associated with rotator cuff tears in 90% of shoulders, and biceps tendonitis may be due to abnormal glenohumeral mechanics created by a deficient rotator cuff – it is rare to have isolated rotator cuff injuries (Saltzman et al. 2017).

2.1.3 Treatment overview

Nonoperative management: Forms the first-line treatment for impingement, tears, tendinopathy and arthropathy. Comprises physical therapy focusing on range of motion, scapular control and strengthening of the rotator cuff and scapular musculature (Kuhn 2009; Kuhn et al. 2013). Physical therapy is also prescribed routinely for facilitating recovery from surgical intervention. Patients may be prescribed analgesia and nonsteroidal anti-inflammatories (NSAIDs), or steroid injections to control pain and inflammation-related symptoms in combination with physical therapy to manage rotator cuff pathology. If appropriate, the patient may be prescribed a cast or splint to immobilise the shoulder in the initial stages of recovery.

Rotator Cuff Repair: Torn tendons are repaired with a direct suture of the tendon tissue and reattachment to the humeral insertion, where required. The repair will be performed with access to the joint via an arthroscopic approach. Repair sutures are usually arranged in a double row of anchors (PEEK, biocomposite, or titanium) and sutures (fibrewire, tiger-tail). The repair may be supplemented by adjunct procedures such as biceps tenodesis.

Subacromial decompression: Procedures addressing issues of the subacromial space such as acromioplasty, bursectomy or coracoacromial ligament release are utilised in full-thickness rotator cuff tear (Familiari et al. 2015), or in severe cases of impingement. These procedures may also form an adjunct to rotator cuff repair, with the aim of reducing impingement on the rotator cuff, or reducing the critical shoulder angle to reduce the likelihood of retear or compromised abductor strength (Gerber et al. 2018).

Manipulation under anaesthesia: Manipulation under anaesthesia may be performed on patients experiencing symptoms of frozen shoulder following a previous rotator cuff repair. In this procedure the patient's arm is manipulated beyond its usual range of motion in order to loosen adhesions in the shoulder capsule.

Arthroscopic capsular release: Patients experiencing ongoing stiffness following a previous rotator cuff repair may undergo arthroscopic procedures including capsulotomy, in order to release capsular ligaments and adhesions which are restricting range of motion. Both capsulotomy and MUA are effective at restoring range of motion in patients with frozen shoulder, however evidence is not strong enough to suggest one over the other (Grant et al. 2013).

Arthroplasty: In cases of rotator cuff arthropathy indicated for surgical intervention, a primary reverse total shoulder replacement is performed (Petrillo et al. 2017). This procedure may include bone grafting on the humeral head or glenoid, as well as repair of the subscapularis tendon (Edwards et al. 2009), or biceps tenodesis.

Postoperative rehabilitation: Postoperative rehabilitation is routinely prescribed for patients undergoing surgical procedures for rotator cuff pathology.

2.1.4 Summary and gap

• There is a lack of evidence regarding the key factors determining patient outcome following diagnosis and treatment of rotator cuff pathologies.
• The clinical superiority of surgical repair compared to nonoperative management for rotator cuff tear remains unclear.
• The literature suffers from wide variability of study methodology, particularly with regards to the definitions of complications and adverse events.
• The literature does not consider the relationship between modifiable and non-modifiable factors with respect to treatment success.

2.1.5 Cohort aims and hypotheses

The aim of this cohort is to determine in patients presenting with rotator cuff pathology, what patient, pathology and management factors are associated with treatment success at 1 year follow up in an observational cohort study

Hypothesis

Unsuccessful treatment will be significantly associated with a combination of identifiable patient, pathology and management factors

2.1.6 Cohort inclusion/exclusion criteria

Inclusion Criteria

• Primary diagnosis rotator cuff pathology; Any of:
  • Subacromial impingement
  • Rotator cuff tendinopathy
  • Rotator cuff tear (intrasubstance, partial thickness, full thickness)
• Undergoing treatment by primary investigator/orthopaedic consultant surgeon.
• Consenting to being part of the Clinic Patient Registry

Exclusion Criteria

• Patient-reported outcomes: Clinically diagnosed mental/neurological illness (indicated on GP referral, or identified through secondary referral to psychiatric/neurological specialist) that precludes retrieval of patient feedback via interview, paper or electronic questionnaire (e.g., schizophrenia, dementia, Alzheimer's Disease, personality disorder).
• Revocation of consent for research use of personal data.
• Rotator cuff pathology is present, but not deemed to be the primary diagnosis
• Cuff tear arthropathy, defined by bone changes visible on radiology, in the superior humeral head or undersurface of acromion

2.1.7 Core dataset and protocol

The core dataset includes:

• Clinical data
• Patient-reported outcomes
• Imaging
• Functional biomechanics
• Surgical/treatment
• Complications

Diagnosis and Outcomes

Failure or Revision: When a procedure is deemed to have failed as per the definitions stated, the procedure record will be classed as “failed” using the surgery status field in Socrates and a new procedure record will be raised for the patient.

Tear diagnosis on imaging: MRI scan to confirm - tear size, thickness (partial/full), retracted or not; muscle quality and fatty infiltration (all reviewed by the operating surgeon). 3T MRI will be performed for diagnosis of postoperative rotator cuff tear. Tears will be classified as partial or full by the treating surgeon.

Functional tests

Shoulder range of motion: Active range of motion of the shoulder (glenohumeral + scapulothoracic) will be assessed with the patient (sitting, standing) with the scapular unrestrained. Testing position will be standardised (recorded at least) as per the recommendations of Sabari et al. (1998). The patient will be asked to actively move their arm in abduction, forward flexion (abduction + flexion), as well as internal and external rotation with arm by the side, without assistance from the examiner. A goniometer (baseline goniometer, manufacturer, country) with two adjustable overlapping arms, marked at 1deg increments, will be applied to the humerus (one arm) and to the upper torso at the end of the movement.

Patient-reported outcome measures

Western Ontario Rotator Cuff Scale (WORC): The WORC is a 21-item questionnaire with responses indicated on a visual analogue scale (0-100). It addresses physical, sports and recreation, work, lifestyle and emotional domains of health-related quality of life (Kirkley et al. 2003). The WORC demonstrates adequate validity in rotator cuff disease (Ekeberg et al. 2008) and subacromial impingement (Dogu et al. 2013). In addition, it demonstrates the most responsiveness for monitoring changes in symptoms over time (St-Pierre et al. 2016). Question 3 of the WORC refers to perception of weakness in the shoulder, and will be used as a screening question to identify patients ‘of concern’ at 12-month and 2-year follow up.

Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH): The QuickDASH is the 11-item shortened version of a questionnaire assessing activity limitations and symptoms in people with musculoskeletal disorders of the upper limb (Beaton et al. 2005), which has similar measurement properties to the full 30-item DASH (Gummeson et al. 2006), particularly for patients undergoing RCR (MacDermid et al. 2014). A minimum of 10 out of 11 items are required for calculation of a QuickDash score, which ranges from 0 (no disability) to 100 (most severe disability). The MCID score for the QuickDASH is 15.91 points (Franchignoni et al. 2014).

EuroQol 5-Dimension (EQ-5D 5L): The EQ-5D 5L is a generic tool for measuring quality of life, describing health in terms of five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression (Conner-Spady et al. 2015). Patients respond to each item on a 5 level range of severity, following the format of "no problems", "slight problems", "moderate problems", "severe problems", and "unable to or extreme problems". The EQ-5D 5L has been shown to have good validity and discriminatory power in a range of pathologies (Janssen et al. 2013).

MODEMs Expectation Scale: The MODEMS expectations scale is a 6-item instrument developed as part of the MODEMS project (AAOS) as per Tashjian et al (2007). It has demonstrated good internal consistency and re-test reliability. Each item is scored from 1 (lowest level of expectations) to 5 (highest level of expectations), and a mean score for the 6 items is calculated (Zywiel et al. 2013; Dunn et al. 2016).

Patient satisfaction: This will be rated on a 4 point Likert scale as per Clement et al (2018). The patient is asked, "How satisfied are you with the results of your surgery?” and is required to select one of 4 response options; Very Satisfied, Somewhat Satisfied, Somewhat Unsatisfied, and Very Unsatisfied. Patients will also be asked if they would be willing to undergo the same treatment again.

Return to activity (work or sport): This will be addressed using Patient History and follow-up window in Socrates with 8 questions for return to work and 7 questions for return to sport.

Patient Reported Outcome Measures are available for inclusion in Socrates webscores and captured at the timepoints identified in the CDS above.

2.1.9 Cohort secondary outcome measures

Post-operative radiographs: patients receiving an arthroplasty (rTSA) will undergo postoperative radiographs to assess component placement and integrity.

2.1.10 Statistical analysis plan

Background

Here the pre-determined statistical analysis plan for the Shoulder - Rotator Cuff cohort is described, which was finalized prior to any data analysis and to which the investigators will adhere in future analyses. The statistical analysis plan was completed and approved by the registry steering committee on [insert date]. Prospective participant recruitment was commenced [insert date] and following data integrity checks (as per Section 3 of this document), the cohort dataset (including retrospective data prior to relaunch) will be locked on an annual basis and the statistical analysis as specified below will be performed.

Analysis Objectives/Questions

The analysis plan is derived directly from the cohort questions linked below.

Design

The Shoulder - Rotator Cuff cohort analysis is a non-randomised observational study with census sampling (all patients presenting to the registry sites are included). Consecutive patients from the community seeking care for rotator cuff pathologies following primary care referral will be screened by the participating consultant / orthopaedic surgeon for eligibility into the logistic regression analysis.

Patient inclusion/exclusion

Alterations from cohort criteria: No

Treatment allocation

Patients will be allocated to a treatment pathway (surgery, arthroplasty, non-surgical management, observation-only) as per the consultant surgeon’s clinical judgement and shared decision-making with the patient.

Sample Size

Sample size calculations were based upon a rule of thumb of 10 rotator cuff failure events per variable entered into the model (Vittinghoff and McCulloch 2007), assuming a failure rate of 20%. A sample size of 1050 patients will have 80% power to detect a significant effect for 21 variables, allowing for up to 10% cohort protocol non-compliance and a two-sided alpha of 0.05. The failure rate is estimated from Le et al. (2014), which described a statistical model of predictors of retear following rotator cuff repair.

Preliminaries

The flow of patients through entry into the cohort and analysis will be displayed in a flow diagram as per STROBE guidelines (Strengthening The Reporting of Observational Studies in Epidemiology) (Figure 2.1.c) (Vandenbroucke et al. 2007). The number of exclusions and loss to followup will be noted from screening, data collection and analysis phases.

Data collection and follow-up

As per registry methods. Approval is also sought to invite patients who have not previously consented to participate in research to return patient reported outcome measures for the purposes of this study.

Variations from Cohort core dataset: No

Data Integrity

Initial statistical analysis will include examining data consistency and examining outliers in more detail. Where outliers in patient reported outcomes, surgical or clinical information are identified, source material will be examined and transcription errors rectified. Where the source material contains an outlier value, a decision will be made regarding the validity of the value. This will be reported in the published results and the datum excluded from further analysis if required.

As per Section 3 - quality management

Handling missing data

Missing data will be identified during the initial data quality assessment. Missing data identified in the electronic registry database will be investigated in the original source material where available. In patients with missing data who are eligible for follow-up, attempts will be made to contact the patient (mail and phone) to complete patient-reported outcomes. When the number of patients required to achieve 80% follow up at a minimum of 1 year has been achieved, missing data rates will be reported.

Variables

Outcomes for primary questions

The proportion of patients labelled as “ongoing” in surgical status, having met the criteria for surgical success.

Demographics and baseline characteristics

As per cohort core dataset

Analyses

Principles (incl. blinding)

Randomisation not applied to the analyses. Analyses will be performed with de-identified data (single-sided blinding)

Primary Questions

Binary logistic regression will be used to determine the association of demographic, anatomical, pathology and management factors and surgical success at up to two year follow up.