Clinical and radiological outcome of conservative vs. surgical treatment of atraumatic degenerative rotator cuff rupture: design of a randomized controlled trial

BMC Musculoskeletal Disorders

Study Protocol

Jos JAM van Raay¹  Inge van den Akker-Scheek¹  Frederik O Lambers Heerspink¹  Ron L Diercks²  Pepijn JM van Eerden³  Roy AG Hoogeslag⁴ 

[1] Martini Hospital Groningen Department of Orthopaedic Surgery, PO 30 0033, 9700RM, Groningen, The Netherlands;University Medical Center Groningen Department of Orthopaedic Surgery, O 30 001, 9700 RB, Groningen, The Netherlands;University Medical Center Groningen Department of Radiology, PO 30 001, 9700 RB, Groningen, The Netherlands;Zorggroep Twente Department of Orthopaedic Surgery, PO 7600, 7600 SZ, Almelo, The Netherlands;

关键词: Rotator Cuff;    Rotator Cuff Repair;    Fatty Degeneration;    Shoulder Function;    Freeze Shoulder;   

DOI  :  10.1186/1471-2474-12-25

 received in 2010-12-07, accepted in 2011-01-26,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundSubacromial impingement syndrome is a frequently observed disorder in orthopedic practice. Lasting symptoms and impairment may occur when a subsequent atraumatic rotator cuff rupture is also present. However, degenerative ruptures of the rotator cuff can also be observed in asymptomatic elderly individuals. Treatment of these symptomatic degenerative ruptures may be conservative or surgical. Acceptable results are reported for both treatment modalities. No evidence-based level-1 studies have been conducted so far to compare these treatment modalities. The objective of this study is to determine whether there is a difference in outcome between surgical reconstruction and conservative treatment of a degenerative atraumatic rotator cuff tendon rupture.Methods/DesignA randomized controlled trial will be conducted. Patients aged between 45 and 75 with a symptomatic atraumatic rotator cuff rupture as diagnosed by MRI will be included. Exclusion criteria are traumatic rotator cuff rupture, frozen shoulder and diabetes mellitus. Patients will be randomized into two groups. Conservative treatment includes physical therapy according to a standardized protocol, NSAIDs and, if indicated, subacromial infiltration with a local anesthetic and corticosteroids. Surgical reconstruction is performed under general anesthesia in combination with an interscalenus plexus block. An acromioplasty with reconstruction of the rotator cuff tendon is performed, as described by Rockwood et al. Measurements take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively. The primary outcome measure is the Constant score. Secondary measures include both disease-specific and generic outcome measures, and an economic evaluation. Additionally, one year after inclusion a second MRI will be taken of all patients in order to determine whether extent and localization of the rupture as well as the amount of fatty degeneration are prognostic factors.DiscussionBoth surgical as conservative treatment of a symptomatic atraumatic rotator cuff tendon rupture is used in current practice. There is a lack of level-1 studies comparing surgical vs. conservative treatment. This randomized controlled trial has been designed to determine whether the surgical treatment of a degenerative atraumatic rotator cuff tendon rupture may lead to a better functional and radiological outcome than conservative treatment after one year of follow-up.Trial registration numberNetherlands Trial Register (NTR): NTRTC2343

【 授权许可】

CC BY   
© Lambers Heerspink et al; licensee BioMed Central Ltd. 2011