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No Functional Difference Between Three and Six Weeks of Immobilization After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Non-Inferiority Trial

Published:September 05, 2018DOI:https://doi.org/10.1016/j.arthro.2018.05.036

      Purpose

      The aim of this study was to compare clinical and radiologic results among patients with 3 versus 6 weeks of immobilization after arthroscopic rotator cuff (RC) repair in a prospective randomized controlled non-inferiority trial.

      Methods

      One hundred twenty patients were included after RC surgery for a small- to medium-sized tear of supraspinatus and upper infraspinatus tendons. Group A was immobilized in a simple sling for 3 weeks, and group B had a brace with a small abduction pillow with the arm in neutral position for 6 weeks. All patients started active range of motion when they removed the sling/brace. One hundred eighteen (98%) patients were assessed at 1-year follow-up. They underwent magnetic resonance imaging (MRI) of the shoulder, filled out the Western Ontario Rotator Cuff (WORC) index, and were evaluated with a Constant Murley (CM) score.

      Results

      Statistical non-inferiority was demonstrated for the 2 groups on the basis of the WORC index, the primary endpoint at 1 year. The objective for the non-inferiority test was to determine whether the expected mean WORC index for group A was at most 13% worse than standard treatment (Group B). The WORC index at 1 year was similar in both groups, with mean percent scores of 83% in group A and 87% in group B (mean difference = −4; 95% one-sided CI −9, −4). Age-adjusted CM scores were also similar, with means of 86 in group A and 90 in group B (mean difference = −4; 95% CI −13, 5; P = .37). MRI after 1 year showed 50 (89%) patients in each group with healed RC repair. Four patients in group A had complications: 1 acute postoperative infection, 2 cases of postoperative capsulitis treated with corticosteroid injections, and 1 repeat operation because of a loose anchor and subacromial pain. No patients in group B had complications.

      Conclusion

      RC repair resulted in improved postoperative shoulder function, regardless of whether the shoulder was immobilized for 3 or 6 weeks. Three weeks of postoperative immobilization with sling use was non-inferior to the commonly used regimen involving 6 weeks of immobilization in a brace with regard to the WORC index at 12 months' follow-up. MRI indicated similar degrees of healing between the groups. Based on these findings, it is safe to immobilize patients in a simple sling for 3 to 6 weeks after repair of small to medium RC tears.

      Level of evidence

      Level I, high-quality randomized controlled trial with statistically significant differences.
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      References

        • Parsons B.O.
        • Gruson K.I.
        • Chen D.D.
        • Harrison A.K.
        • Gladstone J.
        • Flatow E.L.
        Does slower rehabilitation after arthroscopic rotator cuff repair lead to long-term stiffness?.
        J Shoulder Elbow Surg. 2010; 19: 1034-1039
        • Brislin K.J.
        • Field L.D.
        • Savoie 3rd, F.H.
        Complications after arthroscopic rotator cuff repair.
        Arthroscopy. 2007; 23: 124-128
        • Huberty D.P.
        • Schoolfield J.D.
        • Brady P.C.
        • Vadala A.P.
        • Arrigoni P.
        • Burkhart S.S.
        Incidence and treatment of postoperative stiffness following arthroscopic rotator cuff repair.
        Arthroscopy. 2009; 25: 880-890
        • Arndt J.
        • Clavert P.
        • Mielcarek P.
        • et al.
        Immediate passive motion versus immobilization after endoscopic supraspinatus tendon repair: A prospective randomized study.
        Orthop Traumatol Surg Res. 2012; 98: S131-S138
        • Mazuquin B.F.
        • Wright A.C.
        • Russell S.
        • Monga P.
        • Selfe J.
        • Richards J.
        Effectiveness of early compared with conservative rehabilitation for patients having rotator cuff repair surgery: An overview of systematic reviews.
        Br J Sports Med. 2018; 52: 111-121
        • Mazzocca A.D.
        • Arciero R.A.
        • Shea K.P.
        • et al.
        The effect of early range of motion on quality of life, clinical outcome, and repair integrity after arthroscopic rotator cuff repair.
        Arthroscopy. 2017; 33: 1138-1148
        • Duzgun I.
        • Baltaci G.
        • Atay O.A.
        Comparison of slow and accelerated rehabilitation protocol after arthroscopic rotator cuff repair: pain and functional activity.
        Acta orthop. 2011; 45: 23-33
        • Abtahi A.M.
        • Granger E.K.
        • Tashjian R.Z.
        Factors affecting healing after arthroscopic rotator cuff repair.
        World J Orthop. 2015; 6: 211-220
        • Cuff D.J.
        • Pupello D.R.
        Prospective randomized study of arthroscopic rotator cuff repair using an early versus delayed postoperative physical therapy protocol.
        JShoulder Elbow Surg. 2012; 21: 1450-1455
        • Sonnabend D.H.
        • Howlett C.R.
        • Young A.A.
        Histological evaluation of repair of the rotator cuff in a primate model.
        J. Bone Joint Surg Br. 2010; 92: 586-594
        • Gerber C.
        • Schneeberger A.G.
        • Perren S.M.
        • Nyffeler R.W.
        Experimental rotator cuff repair. A preliminary study.
        J Bone Joint Surg. 1999; 81: 1281-1290
        • Rodeo S.A.
        • Arnoczky S.P.
        • Torzilli P.A.
        • Hidaka C.
        • Warren R.F.
        Tendon-healing in a bone tunnel. A biomechanical and histological study in the dog.
        J Bone Joint Surg. 1993; 75: 1795-1803
        • Lu H.H.
        • Thomopoulos S.
        Functional attachment of soft tissues to bone: Development, healing, and tissue engineering.
        Annu Rev Biomed Eng. 2013; 15: 201-226
        • Thomopoulos S.
        • Williams G.R.
        • Soslowsky L.J.
        Tendon to bone healing: Differences in biomechanical, structural, and compositional properties due to a range of activity levels.
        J Biomech Eng. 2003; 125: 106-113
        • Gimbel J.A.
        • Van Kleunen J.P.
        • Williams G.R.
        • Thomopoulos S.
        • Soslowsky L.J.
        Long durations of immobilization in the rat result in enhanced mechanical properties of the healing supraspinatus tendon insertion site.
        J Biomech Eng. 2007; 129: 400-404
        • Peltz C.D.
        • Dourte L.M.
        • Kuntz A.F.
        • et al.
        The effect of postoperative passive motion on rotator cuff healing in a rat model.
        J Bone Joint Surg. 2009; 91: 2421-2429
        • Lee B.G.
        • Cho N.S.
        • Rhee Y.G.
        Effect of two rehabilitation protocols on range of motion and healing rates after arthroscopic rotator cuff repair: Aggressive versus limited early passive exercises.
        Arthroscopy. 2012; 28: 34-42
        • Keener J.D.
        • Galatz L.M.
        • Stobbs-Cucchi G.
        • Patton R.
        • Yamaguchi K.
        Rehabilitation following arthroscopic rotator cuff repair: A prospective randomized trial of immobilization compared with early motion.
        J Bone Joint Surg. 2014; 96: 11-19
        • Kim Y.S.
        • Chung S.W.
        • Kim J.Y.
        • Ok J.H.
        • Park I.
        • Oh J.H.
        Is early passive motion exercise necessary after arthroscopic rotator cuff repair?.
        Am J Sports Med. 2012; 40: 815-821
        • Saltzman B.M.
        • Zuke W.A.
        • Go B.
        • et al.
        Does early motion lead to a higher failure rate or better outcomes after arthroscopic rotator cuff repair? A systematic review of overlapping meta-analyses.
        J Shoulder Elbow Surg. 2017; 26: 1681-1691
        • De Roo P.J.
        • Muermans S.
        • Maroy M.
        • Linden P.
        • Van den Daelen L.
        Passive mobilization after arthroscopic rotator cuff repair is not detrimental in the early postoperative period.
        Acta Orthop Belg. 2015; 81: 485-492
        • Koh K.H.
        • Lim T.K.
        • Shon M.S.
        • Park Y.E.
        • Lee S.W.
        • Yoo J.C.
        Effect of immobilization without passive exercise after rotator cuff repair: randomized clinical trial comparing four and eight weeks of immobilization.
        J Bone Joint Surg. 2014; 96: e44
        • Constant C.R.
        • Murley A.H.
        A clinical method of functional assessment of the shoulder.
        Clin Orthop Relat Res. 1987; : 160-164
        • Katolik L.I.
        • Romeo A.A.
        • Cole B.J.
        • Verma N.N.
        • Hayden J.K.
        • Bach B.R.
        Normalization of the Constant score.
        J Shoulder Elbow Surgery. 2005; 14: 279-285
        • Kirkley A.
        • Alvarez C.
        • Griffin S.
        The development and evaluation of a disease-specific quality-of-life questionnaire for disorders of the rotator cuff: The Western Ontario Rotator Cuff Index.
        Clin J Sport Med. 2003; 13: 84-92
        • Ekeberg O.M.
        • Bautz-Holter E.
        • Keller A.
        • Tveita E.K.
        • Juel N.G.
        • Brox J.I.
        A questionnaire found disease-specific WORC index is not more responsive than SPADI and OSS in rotator cuff disease.
        J Clin Epidemiol. 2010; 63: 575-584
        • Thomazeau H.
        • Boukobza E.
        • Morcet N.
        • Chaperon J.
        • Langlais F.
        Prediction of rotator cuff repair results by magnetic resonance imaging.
        Clin Orthop Relat Res. 1997; : 275-283
        • Goutallier D.
        • Postel J.M.
        • Gleyze P.
        • Leguilloux P.
        • Van Driessche S.
        Influence of cuff muscle fatty degeneration on anatomic and functional outcomes after simple suture of full-thickness tears.
        J Shoulder Elbow Surg. 2003; 12: 550-554
        • Sugaya H.
        • Maeda K.
        • Matsuki K.
        • Moriishi J.
        Functional and structural outcome after arthroscopic full-thickness rotator cuff repair: single-row versus dual-row fixation.
        Arthroscopy. 2005; 21: 1307-1316
        • Julious S.A.
        Sample sizes for clinical trials with normal data.
        Stat Med. 2004; 23: 1921-1986
        • Piaggio G.
        • Elbourne D.R.
        • Pocock S.J.
        • Evans S.J.
        • Altman D.G.
        • Group C.
        Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement.
        JAMA. 2012; 308: 2594-2604
        • Millett P.J.
        • Wilcox 3rd, R.B.
        • O'Holleran J.D.
        • Warner J.J.
        Rehabilitation of the rotator cuff: An evaluation-based approach.
        J Am Acad Orthop Surg. 2006; 14: 599-609
        • Thigpen C.A.
        • Shaffer M.A.
        • Gaunt B.W.
        • Leggin B.G.
        • Williams G.R.
        • Wilcox 3rd, R.B.
        The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair.
        J Shoulder Elbow Surgery. 2016; 25: 521-535
        • Hsu J.E.
        • Horneff J.G.
        • Gee A.O.
        Immobilization after rotator cuff repair: what evidence do we have now?.
        Orthop Clin North Am. 2016; 47: 169-177
        • Littlewood C.
        • Bateman M.
        Rehabilitation following rotator cuff repair: A survey of current UK practice.
        Shoulder Elbow. 2015; 7: 193-204
        • Gilotra M.
        • Nguyen T.
        • Christian M.
        • Davis D.
        • Henn 3rd, R.F.
        • Hasan S.A.
        Botulinum toxin is detrimental to repair of a chronic rotator cuff tear in a rabbit model.
        J Orthop Res. 2015; 33: 1152-1157
        • Gilotra M.N.
        • Shorofsky M.J.
        • Stein J.A.
        • Murthi A.M.
        Healing of rotator cuff tendons using botulinum toxin A and immobilization in a rat model.
        BMC Musculoskelet Disord. 2016; 17: 127
        • Galatz L.M.
        • Charlton N.
        • Das R.
        • Kim H.M.
        • Havlioglu N.
        • Thomopoulos S.
        Complete removal of load is detrimental to rotator cuff healing.
        J Shoulder Elbow Surg. 2009; 18: 669-675
        • Raschhofer R.
        • Poulios N.
        • Schimetta W.
        • Kisling R.
        • Mittermaier C.
        Early active rehabilitation after arthroscopic rotator cuff repair: A prospective randomized pilot study.
        Clin Rehabil. 2017; 31: 1332-1339
        • Mollison S.
        • Shin J.J.
        • Glogau A.
        • Beavis R.C.
        Postoperative rehabilitation after rotator cuff repair: A web-based survey of AANA and AOSSM Members.
        Orthop J Sports Med. 2017; 5 (2325967116684775)
        • Hollman F.
        • Wolterbeek N.
        • Zijl J.A.C.
        • van Egeraat S.P.M.
        • Wessel R.N.
        Abduction brace versus antirotation sling after arthroscopic cuff repair: the effects on pain and function.
        Arthroscopy. 2017; 33: 1618-1626
        • Conti M.
        • Garofalo R.
        • Castagna A.
        Does a brace influence clinical outcomes after arthroscopic rotator cuff repair?.
        Musculoskelet Surg. 2015; 99: S31-S35
        • Pandey V.
        • Jaap Willems W.
        Rotator cuff tear: A detailed update.
        Asia-Pacific J Sports Med Arthroscop Rehabil Technol. 2015; 2: 1-14
        • Yang G.
        • Im H.J.
        • Wang J.H.
        Repetitive mechanical stretching modulates IL-1beta induced COX-2, MMP-1 expression, and PGE2 production in human patellar tendon fibroblasts.
        Gene. 2005; 363: 166-172

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