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    Interventional procedure overview of biodegradable subacromial spacer insertion for rotator cuff tears.

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    Outcome measures

    The main outcomes included are OSS, the ASES score, the Constant Score, the WORC index score, VAS for pain, EQ-5D-5L quality of life score, active ROM and patient satisfaction. The measures used are detailed in the following paragraphs.

    The OSS is a 12-item participant-reported measure (scored 0 to 48; where 48 is the best score) of shoulder-related pain and function. Its published MCID is 6.

    The ASES score is a mixed outcome reporting measure, divided into pain and Activities of Daily Living (ADL) domains, for use in a variety of shoulder pathologies. Results are in the 0 to 100 range, where 100 indicates the best shoulder condition. The MCID in ASES score is 17.

    The Constant (or Constant-Murley) score consists of four variables that are used to assess the function of the shoulder. The objective variables are ROM and strength which give a total of 65 points. The subjective variables are pain and ADL (sleep, work, recreation or sport), which give a total of 35 points. These can be combined to give a score out of 100, with 0 as the worst shoulder function and 100 as the best. The MCID in Constant Score has been shown to be 10.4 points.

    The WORC Index is a disease-specific quality of life questionnaire, evaluating symptoms and functional ability. It is self-administered and has 21-items relating to 5 domains (physical symptoms, sports or recreation, work, social function, emotions). The maximum score is 2100 (worst possible symptoms) and 0 represents no symptoms. Its MCID is 245 points of the total score.

    The VAS score is an unidimensional measure of pain intensity, used to record patients' pain progression or to compare pain severity between patients with similar conditions. Pain is shown spatially as distance along a straight line, usually 10 cm, anchored by 2 verbal descriptors, one for each symptom extreme. The score is determined by measuring the distance on the line between the 'no pain' anchor and the patient's mark. The MCID has been found to be 1.4.

    The EQ-5D-5L is a self-reported survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is scored on a 5-level severity ranking that ranges from 'no problems' through to 'extreme problems'. It is assessed on a scale of 1 to 5 with a lower score indicating better quality of life.

    Active ROM measures the totality of movement the shoulder is capable of doing. Active (as opposed to passive) ROM assesses independent movement. The movements that are most commonly assessed are: abduction, forward flexion, forward elevation and external rotation.