This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.
4.1 A prospective case series of 20 patients with massive irreparable rotator cuff tear reported a significant increase in total Constant score (0 to 100, from worst to best outcomes) of 31.54 points 3 years after the procedure (p<0.0001). No improvement in the total Constant score was reported in 10% (2/20) of patients; MRI of these 2 patients 3 years after implantation showed suspected synovitis without cystic formation (reported in section 5.2).
4.2 The prospective case series of 20 patients also reported the following significant findings 3 years after the procedure (all p<0.0001): an increase in activity of daily living score (0 to 20, from worst to best) of 9.24 points; an increase in range of motion score (0 to 40, from worst to best) of 8.1 points; an increase in power score (0 to 25, from worst to best) of 7.19 points; an increase in subjective pain score (0 to 15, from worst to best) of 6.44 points; and an increase in night pain score of 1.05 points (scale not given).
4.3 The specialist advisers listed key efficacy outcomes as decrease in pain (particularly at night), increase in range of movement and improvement in shoulder function.
4.4 Three commentaries from patients who had experience of this procedure were received, which were discussed by the committee.