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Literature Review:

Effectiveness of Rotator Cuff Surgery

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.

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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
     

BioTend 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.

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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 the results of repair for large tears and shows a success rate determined by imaging of 52% (range of 5% - 90%). 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.

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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.

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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.

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References

  1. PearlDiver. Available from: http://www.pearldiverinc.com

  2. Galatz, L.M., et al., The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am, 2004. 86-A(2): p. 219-24.

  3. Harryman, D.T., 2nd, et al., Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am, 1991. 73(7): p. 982-9.

  4. Thomazeau, H., et al., Prediction of rotator cuff repair results by magnetic resonance imaging. Clin Orthop Relat Res, 1997(344): p. 275-83.

  5. Gerber, C., B. Fuchs, and J. Hodler, The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am, 2000. 82(4): p. 505-15.

  6. Iannotti, J.P., et al., Porcine small intestine submucosa augmentation of surgical repair of chronic two-tendon rotator cuff tears. A randomized, controlled trial. J Bone Joint Surg Am, 2006. 88(6): p. 1238-44.

  7. Nho, S.J., et al., Prospective analysis of arthroscopic rotator cuff repair: prognostic factors affecting clinical and ultrasound outcome. J Shoulder Elbow Surg, 2009. 18(1): p. 13-20.

  8. Klepps, S., et al., Prospective evaluation of the effect of rotator cuff integrity on the outcome of open rotator cuff repairs. Am J Sports Med, 2004. 32(7): p. 1716-22.

  9. Bishop, J., et al., Cuff integrity after arthroscopic versus open rotator cuff repair: a prospective study. J Shoulder Elbow Surg, 2006. 15(3): p. 290-9.

  10. Boileau, P., et al., Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am, 2005. 87(6): p. 1229-40.

  11. DeFranco, M.J., et al., Functional outcome of arthroscopic rotator cuff repairs: a correlation of anatomic and clinical results. J Shoulder Elbow Surg, 2007. 16(6): p. 759-65.

  12. Ko, S.H., et al., Arthroscopic single-row supraspinatus tendon repair with a modified mattress locking stitch: a prospective, randomized controlled comparison with a simple stitch. Arthroscopy, 2008. 24(9): p. 1005-12.

  13. Calvert, P.T., et al., Arthrography of the shoulder after operative repair of the torn rotator cuff. J Bone Joint Surg Br, 1986. 68(1): p. 147-50.

  14. Goutallier, D., et al., Fatty muscle degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop Relat Res, 1994(304): p. 78-83.

  15. Jost, B., et al., Clinical outcome after structural failure of rotator cuff repairs. J Bone Joint Surg Am, 2000. 82(3): p. 304-14.

  16. Gazielly, D.F., P. Gleyze, and C. Montagnon, Functional and anatomical results after rotator cuff repair. Clin Orthop Relat Res, 1994(304): p. 43-53.

  17. Ellman, H., S.P. Kay, and M. Wirth, Arthroscopic treatment of full-thickness rotator cuff tears: 2- to 7-year follow-up study. Arthroscopy, 1993. 9(2): p. 195-200.

  18. Fuchs, B., et al., Clinical and structural results of open repair of an isolated one-tendon tear of the rotator cuff. J Bone Joint Surg Am, 2006. 88(2): p. 309-16.

  19. Gartsman, G.M. and S.M. Hammerman, Full-thickness tears: arthroscopic repair. Orthop Clin North Am, 1997. 28(1): p. 83-98.

  20. Iannotti, J.P., et al., Accuracy of office-based ultrasonography of the shoulder for the diagnosis of rotator cuff tears. J Bone Joint Surg Am, 2005. 87(6): p. 1305-11.

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