Abstract: The selection of an immobilization device and arm positioning may play a role in postoperative pain and healing after arthroscopic rotator cuff repair.
Editorial Commentary: Better Care, Better Health, Better Cost: Is Scientific Evidence Negatively Impacting the Transformation of Health Care? Kevin David Plancher, M.D., Editorial Board
Abstract: The selection of an immobilization device and arm positioning may play a role in postoperative pain and healing after arthroscopic rotator cuff repair. Although the current evidence is inconclusive, it is important that we aim as a profession to produce meaningful evidence that will advance the care of our patients while controlling health care costs.
See related article on page 1618
H
ollman, Wolterbeek, Zijl, van Egeraat, and Wessel in their article entitled “Abduction Brace Versus Anti-rotation Sling After Arthroscopic Cuff Repair: The Effects on Pain and Function. A Randomized Controlled Trial”1 attempted to determine if arm positioning impacted postoperative pain after arthroscopic rotator cuff repair. Their primary endpoint was not rotator cuff integrity but rather assessment of pain on a visual analog scale after rotator cuff repair. The authors found no difference in pain and functional outcomes as measured on the Constant Murley Score and Western Ontario Rotator Cuff Index through 1-year clinical follow-up or assessment of retear by ultrasound at a very short 3-month follow-up. Although the choice of sling after arthroscopic rotator cuff repair did not impact these short-term outcomes, it is important to be a critical consumer of the literature to determine if and how these findings might change or not change our current management after arthroscopic rotator cuff repair. Criticisms before accepting the conclusions by these authors that might be worth noting are as follows. First, the examiners were not blinded to brace allocation contributing to potential bias in the results obtained. Second, doctors in training were used to assess
The author reports the following potential conflicts of interest or sources of funding: Editorial board of Arthroscopy and Operative Techniques in Sports Medicine, and Committee Appointments for AAOS, AANA, ISAKOS, and EOA. Full ICMJE author disclosure forms are available for this article online, as supplementary material. Ó 2017 by the Arthroscopy Association of North America 0749-8063/17564/$36.00 http://dx.doi.org/10.1016/j.arthro.2017.06.009
outcomes that potentially could alter the reliability of the findings. In addition, tear size and tension of the repair may influence perceived pain, and although assessed, they were not used as covariates in the analysis of the data even though tear size was statistically different between groups. Furthermore, despite conducting a power analysis, it was performed only for pain and not other outcomes and the final sample size was smaller than suggested; therefore, the risk of a type II error remains high. Given the small sample size, the crossover in treatment allocation, and that the majority of patients had minimal to no tension on the repair, the dataset is skewed, and therefore the extrapolation of the study results cannot be applied to all patients. Perhaps, it is in these subpopulations that the type of brace prescribed postoperatively may play a role in optimizing healing of the cuff repair. Stiffness after rotator cuff repair has been reported in up to 20% of patients; although most cases resolve with conservative treatment in the first year, up to 3% either have permanent range of motion restrictions or require capsular release.2,3 When stiffness does occur and perhaps initially goes unrecognized, the position of the arm across the chest, common with the use of a sling, can be detrimental to the outcome, whereas a position of neutral rotation may perhaps assist in regaining motion with an intact rotator cuff in a simple fashion. Conti et al.4 supported that the use of an abduction brace after rotator cuff repair led to improved shortterm range of motion and less postoperative pain compared with bracing the arm in internal rotation. We believe in the absence of strong clinical evidence that it is important to use the best in vivo evidence to support
Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol 33, No 9 (September), 2017: pp 1627-1628
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sound clinical judgment and to protect the repair during the acute and subacute phases of healing. The position of approximately 30 of external rotation in the scapular plane, best achieved with an abduction pillow, has been shown to reduce tensile forces on the repaired rotator cuff,5 whereas positions of adduction could reduce blood flow to the supraspinatus that could lead to poor healing.6 Furthermore, a recent randomized trial by Kim et al.7 suggested that 6 weeks of brace immobilization did not negatively impact shoulder range of motion after arthroscopic rotator cuff repair and in fact yielded equal results to those who underwent early initiation of passive shoulder range of motion postoperatively on day 1. The mantra for the transformation of health care has been to improve quality of care while decreasing costs and maintaining the highest standards of care. No different than the financial markets that use big data to transform their services, health care must leverage the best available evidence to reform the delivery of health care to enhance the health of our patients and restore functional ability for all. Position statements through meta-analyses and systematic reviews of the literature have recently been used with increasing frequency. Combining data of potentially flawed studies can often lead to erroneous conclusions and may stray away from best clinical practices. Is this the path desired for evidence-based medicine and for our patients? The end result is that decisions are made by insurance companies who rely on these flawed studies to force clinical decisions on the physician, as has been seen with viscosupplementation for knee osteoarthritis as just one example.8 Outcome measures frequently include traditional measures of survival (mortality), incidence of disease (morbidity), and health-related quality of life issues. In orthopaedics, we often incorporate patient-reported information on satisfaction with the health care services received; however, these measures unfortunately do not assess the full extent of the patient experience. Although socioeconomic factors such as smoking, diet, safe housing, social support, economic opportunity, and exercise are known to have a profound impact on outcomes, there is little agreement on whether or not providers can be held accountable for these confounding effects. When developing, evaluating, and using outcome measures, it is important to recognize the potential impact of all aspects of health including importantly all social determinants of health, as well as critical differences in patient populations often overlooked in published research, to ascertain whether an intervention was truly a benefit to the patient and outcomes. Advancing research has been a cornerstone for the orthopaedic surgeon. So, what drives change in medicine? The mantra today of commercial and government
payers is value. Value in health care can be defined as health outcomes achieved based on the expenditure to achieve the outcome.9 When cost is lowered and the quality raised, value is obtained. Although the authors do not explicitly state cost as a potential motivator for choice of brace, the abduction brace is more costly than the sling and its cost can play a major factor in some health care systems’ choices, and therefore the results of this study could erroneously support this change. As surgeons and health care providers, we need to be much more critical consumers of the literature because there is an overabundance that can affect our lives, change best practice, or even change policy and at times perhaps not for the good of our patients. In addition, as researchers, reviewers, and editors, we must take the responsibility to critically evaluate and be more selective about what is being published in our journals. The question that remains for many is: will transparency that reveals the truth be allowed to surface as we must search to produce improved research quality and evidence to lead the change in the transformation of delivery of health care? Until we can provide sound clinical evidence for the optimal positioning of the arm for rotator cuff healing after surgical repair, we recommend continuing with your present protocol if you are achieving good clinical results without retears whether in an abduction brace or a sling in neutral rotation to slight external rotation.
References 1. Hollman F, Wolterbeek N, Zijl JAC, van Egeraat SPM, Wessel RN. Abduction brace versus antirotation sling after arthroscopic cuff repair: The effects on pain and function. Arthroscopy 2017;33:1618-1626. 2. Vastamaki H, Vastamaki M. Postoperative stiff shoulder after open rotator cuff repair: A 3- to 20-year follow-up study. Scand J Surg 2014;103:263-270. 3. Namdari S, Green A. Range of motion limitation after rotator cuff repair. J Shoulder Elbow Surg 2010;19: 290-296. 4. Conti M, Garofalo R, Castagna A. Does a brace influence clinical outcomes after arthroscopic rotator cuff repair? Musculoskelet Surg 2015;99:S31-S35 (suppl 1). 5. Hatakeyama Y, Itoi E, Pradhan RL, Urayama M, Sato K. Effect of arm elevation and rotation on the strain in the repaired rotator cuff tendon. A cadaveric study. Am J Sports Med 2001;29:788-794. 6. Rathbun JB, Macnab I. The microvascular pattern of the rotator cuff. J Bone Joint Surg Br 1970;52:540-553. 7. Kim YS, Chung SW, Kim JY, Ok JH, Park I, Oh JH. Is early passive motion exercise necessary after arthroscopic rotator cuff repair? Am J Sports Med 2012;40:815-821. 8. Plancher KD. Crisis in medicine: Have we traded technology for our six senses? Am J Orthop 2014;43:496-497. 9. Porter ME, Teisberg EO. Redefining health care: creating valuebased competition on results. Boston: Harvard Business School Press, 2006.
