Review of Effectiveness

Rotator Cuff Tear and the Effectiveness of Surgical Repair
Rotator cuff tears are a common source of debilitating shoulder pain, reduced strength, weakness, and more than 400,000 rotator cuff surgical procedures are performed annually in the US [1]. Although the surgery can relieve pain for most people and rehabilitation can restore functional range of motion, re-tear of the repair is a relatively frequent occurrence [see Tables 1, 2, 3]. There is a recognized need to improve the clinical and functional outcome of rotator cuff surgery.

Patients with Rotator Cuff Tears at Risk of Re-Tear after Surgery
All patients undergoing surgery for rotator cuff repair have some risk that the surgery will fail and the repair will re-tear as determined by imaging (MRI or ultrasound), although that may or may not be reflected in the clinical outcome. Those most at risk include those with:

  • Large (3 - 5 cm) or massive (>5 cm, two tendon) tear (see below)
  • Previous failed rotator cuff surgery at that site
  • Chronic tear

X-Repair is designed to reinforce the surgical repair site and protect it from receiving excess load that may result in a re-tear of the rotator cuff tendons, and allow the natural repair process to occur.

Clinical Problem
A review of reports describing outcome of rotator cuff repair assessed using imaging (MRI or ultrasound) shows a range of successful outcomes, between 5% and 90% (Tables 1-3), depending in part on the size of the original tear. A major variable in the outcome of rotator cuff repair is reported to be tear size, and so the summaries are separated into results for massive tears (Table 1), large tears (Table 2), and small to medium tears (Table 3). Results were not included from reports when a confident assessment of the size of the original tears could be made. Table 1 indicates the success in structural restoration of massive tears is modest, ranging from 24% - 63% (average is 40%). Table 2 summarizes results of repair for large tears and shows a success rate by imaging of 52% (range of 5% - 90%), and a level of successful repair of 62% when the data of Galatz et al [2], (5% success) is regarded as an outlier and is not included. Similarly a review of the literature for repair of small to medium tears (1 - 3 cm) where repair was assessed using imaging showed a success rate range of 60 - 79%, with an average of 74%. Overall the data indicates a modest success rate in structural restoration of the rotator cuff by surgery.

Table 1: Massive (2 or more tendons, >5 cm) tears
Authors Surgery, Injury, Imaging Number of patients Success rate
Harryman et al [3] Open, massive (3 tendons), ultrasound, > 2 years 22 32%
Thomazeau et al [4] Open, massive (3-4 tendons), 2 years 5 38%
Gerber et al [5] Open, massive (2 or more tendons, MRI 27 63%
Iannotti et al [6] Open, massive (>5 cm), MRI, 1 year 15 24%
Nho et al [7] Arthroscopic, 2-3 tendon involvement, ultrasound, 1 year 51 45%
Avg = 40%

Table 2: Large (3 - 5 cm) tears
Authors Surgery, Injury, Imaging Number of patients Success rate
Harryman et al [3] Open, large (2 tendons) complete, ultrasound, > 2 years 28 57%
Gerber et al [5] Open, Massive (2 or more tendons, complete tear, MRI 27 63%
Galatz et al [2] Arthroscopic, >2 cm including 2 or more tendons, ultrasound, 1 year 17 5%
Klepps et al [8] Open, large-massive, MRI, 1 year 13 62%
Bishop et al [9] Open/arthroscopic, >3 cm, MRI, 1 year 34 38%
Iannotti et al [6] Open, large (4 - 5 cm), MRI, 1 year 9 90%
Avg = 52%

Table 3: Small to medium (1 - 3 cm) tears
Authors Surgery, Injury, Imaging Number of patients Success rate
Harryman et al [3] Open, full thickness supraspinatus tear, ultrasound, >2 years 49 80%
Klepps et al [8] Open, <3 cm, MRI, 1 year 19 74%
Boileau et al [10] Arthroscopic, full thickness supraspinatus tear, MRI/ultrasound, 6 mo - 3 years 65 71%
Bishop et al [9] Open/arthroscopic, <3cm, MRI, 1 year 38 79%
DeFranco et al [11] Arthroscopic, single tendon (supraspinatus), ultrasound, 22 months 30 60%
Ko et al [12] Arthroscopic, 1.5 - 3 cm, MRI, 6 mo - 3 years 66 77%
Nho et al [7] Arthroscopic, single tendon, ultrasound, 1 year 76 76%
Avg = 74%

Tables 1 - 3: Summaries of published data on repair of rotator cuff tears assessed by imaging, and has been used to provide the data for power analyses to calculate group sizes in the planned clinical studies.

Studies have correlated rotator cuff integrity as assessed by postoperative imaging with outcome and have shown cuff integrity to be an important factor in patient clinical outcomes [3, 13-15]. Studies have also shown that better function and pain relief can be obtained if the cuff is intact postoperatively [3-6, 8, 9, 16]. Nevertheless, there is substantial improvement in clinical scores and patient satisfaction after rotator cuff repair [10, 15, 17-20], particularly those with small to medium tears.


  1. PearlDiver. Available from:
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