NIHR DC Discover

Rotator cuff shoulder injury

NIHR Signal Little to choose between open and keyhole surgery as options for repairing shoulder rotator cuff tears

Published on 1 December 2015

doi: 10.3310/signal-000155

This NIHR-funded trial in people over 50 years looked at whether open surgery compared with keyhole surgery for a common shoulder tear injury and improved shoulder function more. It found that there was little to choose between the two approaches in terms of benefits or costs. The muscles and tendons around the shoulder form the rotator cuff. It is a common site for a tear injury, particularly in middle aged and older people. We don’t know the exact number of GP visits for rotator cuff pain in the UK, however, shoulder pain overall makes up 2.4% of all GP consultations. The trial involved 273 patients and was carried out at 19 hospitals in the UK, so should be representative of UK practice. However, the trial had quite specific criteria for eligible participants’ injuries and some participants did not undergo their allocated operations.

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Why was this study needed?

An estimated 14% of people in the UK have shoulder pain each year and 70% of those are likely to have rotator cuff problems. A tear to the rotator cuff makes it difficult to carry out many everyday activities. Keyhole or arthroscopic surgery is less invasive than open surgery, while open surgery may give the surgeon better access for repair. Until this study, there had only been one small trial in a single hospital on the effectiveness of the operations and no research into cost effectiveness of the different approaches.

What did this study do?

The study started as a randomised controlled trial (called UKUFF) to compare open or arthroscopic surgery to repair a degenerative rotator cuff tear with a conservative strategy of rest, then exercise. However, the conservative management arm of the trial was discontinued as a high proportion of participants were thought to require surgery. The trial therefore recruited 273 participants aged 50 years or more with a degenerative, full-thickness rotator cuff tear to 19 UK hospitals and randomised their treatment to open or arthroscopic surgery. The main outcomes were patient reported scales of shoulder pain and ability to carry out daily activities, including the Oxford Shoulder Score (where 0 is worst function, 48 is best function). Cost effectiveness was based on changes to quality of life. The main outcomes were assessed at two years after surgery.

What did it find?

  • Open or arthroscopic surgery gave similar improvements in the Oxford Shoulder Score by two years after the operation. When analysed by the planned operation two years after arthroscopic surgery the score improved from 26.3 points (standard deviation [SD] 8.2) at baseline to 41.7 (SD 7.9) and for open surgery from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9). This was a non-significant difference between groups. The improvement from baseline for each group was significant and met a three point standard of improvement, set by the researchers as clinically important. Analysis of results by actual surgery undertaken also showed no significant difference between groups’ improved scores.
  • There was no significant difference in costs or quality of life between the two operations by two years after surgery. Overall treatment cost by two years was £2,567 (SD £176) for arthroscopic surgery and £2,699 (SD £149) for open surgery.
  • The rate of re-tear was similarly high in both groups at 46.4% of the arthroscopy group and 38.6% for the open surgery group, a difference that was not statistically different. However, even people whose rotator cuff tendons tore again within two years of surgery still had improved quality of life compared to before the operation. The improvement was similar in both groups. The Oxford Shoulder Score improved in the arthroscopy group to 41.8 (SD 8.8) and for open surgery, to 40.8 (SD 7.6).
  • Only 162 of the 273 participants (59%) actually had a rotator cuff repair operation. About half of the participants who didn’t have an operation found that their symptoms improved without surgery or they came off the waiting list because they became ill with another condition. The other half either had a different procedure or the rotator cuff was not torn or repairable.

What does current guidance say on this issue?

UK commissioning guidance from 2014 advises arthroscopic or open surgery options for rotator cuff repair, but does not make a recommendation on which to use. Similarly, American Association of Orthopedic Surgeons guidance from 2010 states that there is insufficient evidence on which to base choice of arthroscopic or open surgery for repairing the rotator cuff.

What are the implications?

This study recruited participants with a degenerative rotator cuff injury, 91% of whom had already undergone other treatment. Therefore, its findings are not necessarily applicable to younger people with a traumatic or new rotator cuff-related tear or pain. For people similar to those studied in this trial, either open or arthroscopic surgery can increase quality of life and may be equally cost effective. The findings are in line with 2014 UK guidance in offering either operation as options for repairing torn rotator cuff tendons. Patients should now be able to choose between procedures more easily since both improved outcomes but without any differences between them, both approaches therefore seem reasonable options. It is worth noting that the high rate of improvement with conservative, non-operative, management suggests a wait and see approach might be a third option for them.

Citation

Carr AJ, Cooper CD, Campbell MK, et al. Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial]. Health Technol Assess. 2015;19(80):1-218.

This project was funded by the Health Technology Assessment programme of the National Institute for Health Research.

Bibliography

AAOC. Optimizing the management of rotator cuff problems. Rosemont (IL): American Academy of Orthopedic Surgeons; 2010.

Commissioning guide 2014. Subacromial shoulder pain. London: British Elbow & Shoulder Society (BESS), British Orthopaedic Association (BOA), Royal College of Surgeons for England (RCSEng); 2014.

Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996;78(4):593–600.

Dawson J, Rogers K, Fitzpatrick R, Carr A. The Oxford Shoulder Score revisited. Arch Orthop Trauma Surg. 2009;129(1):119–23.

Payne, J. Rotator cuff disorders [internet]. Leeds; Patient; 2015.

Why was this study needed?

An estimated 14% of people in the UK have shoulder pain each year and 70% of those are likely to have rotator cuff problems. A tear to the rotator cuff makes it difficult to carry out many everyday activities. Keyhole or arthroscopic surgery is less invasive than open surgery, while open surgery may give the surgeon better access for repair. Until this study, there had only been one small trial in a single hospital on the effectiveness of the operations and no research into cost effectiveness of the different approaches.

What did this study do?

The study started as a randomised controlled trial (called UKUFF) to compare open or arthroscopic surgery to repair a degenerative rotator cuff tear with a conservative strategy of rest, then exercise. However, the conservative management arm of the trial was discontinued as a high proportion of participants were thought to require surgery. The trial therefore recruited 273 participants aged 50 years or more with a degenerative, full-thickness rotator cuff tear to 19 UK hospitals and randomised their treatment to open or arthroscopic surgery. The main outcomes were patient reported scales of shoulder pain and ability to carry out daily activities, including the Oxford Shoulder Score (where 0 is worst function, 48 is best function). Cost effectiveness was based on changes to quality of life. The main outcomes were assessed at two years after surgery.

What did it find?

  • Open or arthroscopic surgery gave similar improvements in the Oxford Shoulder Score by two years after the operation. When analysed by the planned operation two years after arthroscopic surgery the score improved from 26.3 points (standard deviation [SD] 8.2) at baseline to 41.7 (SD 7.9) and for open surgery from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9). This was a non-significant difference between groups. The improvement from baseline for each group was significant and met a three point standard of improvement, set by the researchers as clinically important. Analysis of results by actual surgery undertaken also showed no significant difference between groups’ improved scores.
  • There was no significant difference in costs or quality of life between the two operations by two years after surgery. Overall treatment cost by two years was £2,567 (SD £176) for arthroscopic surgery and £2,699 (SD £149) for open surgery.
  • The rate of re-tear was similarly high in both groups at 46.4% of the arthroscopy group and 38.6% for the open surgery group, a difference that was not statistically different. However, even people whose rotator cuff tendons tore again within two years of surgery still had improved quality of life compared to before the operation. The improvement was similar in both groups. The Oxford Shoulder Score improved in the arthroscopy group to 41.8 (SD 8.8) and for open surgery, to 40.8 (SD 7.6).
  • Only 162 of the 273 participants (59%) actually had a rotator cuff repair operation. About half of the participants who didn’t have an operation found that their symptoms improved without surgery or they came off the waiting list because they became ill with another condition. The other half either had a different procedure or the rotator cuff was not torn or repairable.

What does current guidance say on this issue?

UK commissioning guidance from 2014 advises arthroscopic or open surgery options for rotator cuff repair, but does not make a recommendation on which to use. Similarly, American Association of Orthopedic Surgeons guidance from 2010 states that there is insufficient evidence on which to base choice of arthroscopic or open surgery for repairing the rotator cuff.

What are the implications?

This study recruited participants with a degenerative rotator cuff injury, 91% of whom had already undergone other treatment. Therefore, its findings are not necessarily applicable to younger people with a traumatic or new rotator cuff-related tear or pain. For people similar to those studied in this trial, either open or arthroscopic surgery can increase quality of life and may be equally cost effective. The findings are in line with 2014 UK guidance in offering either operation as options for repairing torn rotator cuff tendons. Patients should now be able to choose between procedures more easily since both improved outcomes but without any differences between them, both approaches therefore seem reasonable options. It is worth noting that the high rate of improvement with conservative, non-operative, management suggests a wait and see approach might be a third option for them.

Citation

Carr AJ, Cooper CD, Campbell MK, et al. Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial]. Health Technol Assess. 2015;19(80):1-218.

This project was funded by the Health Technology Assessment programme of the National Institute for Health Research.

Bibliography

AAOC. Optimizing the management of rotator cuff problems. Rosemont (IL): American Academy of Orthopedic Surgeons; 2010.

Commissioning guide 2014. Subacromial shoulder pain. London: British Elbow & Shoulder Society (BESS), British Orthopaedic Association (BOA), Royal College of Surgeons for England (RCSEng); 2014.

Dawson J, Fitzpatrick R, Carr A. Questionnaire on the perceptions of patients about shoulder surgery. J Bone Joint Surg Br. 1996;78(4):593–600.

Dawson J, Rogers K, Fitzpatrick R, Carr A. The Oxford Shoulder Score revisited. Arch Orthop Trauma Surg. 2009;129(1):119–23.

Payne, J. Rotator cuff disorders [internet]. Leeds; Patient; 2015.

Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial]

Published on 16 October 2015

Carr, A. J.,Cooper, C. D.,Campbell, M. K.,Rees, J. L.,Moser, J.,Beard, D. J.,Fitzpatrick, R.,Gray, A.,Dawson, J.,Murphy, J.,Bruhn, H.,Cooper, D.,Ramsay, C. R.

Health Technol Assess Volume 19 , 2015

BACKGROUND: Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged >/= 50 years with degenerative rotator cuff tendon tears. DESIGN: Two parallel-group randomised controlled trial. SETTING: Nineteen teaching and district general hospitals in the UK. PARTICIPANTS: Patients (n = 273) aged >/= 50 years with degenerative rotator cuff tendon tears. INTERVENTIONS: Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation. MAIN OUTCOME MEASURES: The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair. RESULTS: The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was -0.76 [95% confidence interval (CI) -2.75 to 1.22; p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score -0.46, 95% CI -5.30 to 4.39; p = 0.854). The questionnaire response rate was > 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component resource-use categories, nor for the total follow-up costs at 24 months. The overall treatment cost at 2 years was pound2567 (SD pound176) for arthroscopic surgery and pound2699 (SD pound149) for open surgery, according to intention-to-treat analysis. For the per-protocol analysis there was a significant difference in total initial procedure-related costs between the arthroscopic group and the open repair group, with arthroscopic repair being more costly by pound371 (95% CI pound135 to pound607). Total quality-adjusted life-years accrued at 24 months averaged 1.34 (SD 0.05) in the arthroscopic repair group and 1.35 (SD 0.05) in the open repair group, a non-significant difference of 0.01 (95% CI -0.11 to 0.10). The rate of re-tear was not significantly different across the randomised groups (46.4% and 38.6% for arthroscopic and open surgery, respectively). The participants with tears that were impossible to repair had the lowest OSSs, the participants with re-tears had slightly higher OSSs and the participants with healed repairs had the most improved OSSs. These findings were the same when analysed per protocol. CONCLUSION: In patients aged > 50 years with a degenerative rotator cuff tear there is no difference in clinical effectiveness or cost-effectiveness between open repair and arthroscopic repair at 2 years for the primary outcome (OSS) and all other prespecified secondary outcomes. Future work should explore new methods to improve tendon healing and reduce the high rate of re-tears observed in this trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97804283. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 80. See the NIHR Journals Library website for further project information.

The Oxford Shoulder Score is a measure of shoulder pain and function which is assessed by patients themselves. It consists of 12 questions about the last four weeks, concerning ability to carry out activities such as getting dressed, using public transport or doing shopping. Each of the 12 questions is answered with a rating of 0 to 4, where four is the best function and least pain, so the best possible score is 48. In this study, the researchers considered that a three point change represents a clinically important difference.

Expert commentary

Rotator cuff tendon repairs are commonly used to treat a prevalent cause of shoulder pain. The setting and pragmatic nature of this multi-centre clinical trial make its findings immediately applicable in the NHS. The study supports commissioning of rotator cuff repairs, as irrespective of surgical technique or whether the tendon repair heals, patients report sustained improvement of their shoulder pain and function.

Further research to improve tendon healing is crucial, as a healed tendon results in the best outcome. Research into mechanisms by which surgery works and its longer-term outcome would also be of interest to patients, clinicians and commissioners of care.

Professor Amar Rangan, Professor of Orthopaedic Surgery, The James Cook University Hospital, Middlesbrough