Subacromial spacer implantation for massive rotator cuff tears

Holschen, Malte; Brand, Florian; Agneskirchner, Jens D.

doi:10.1007/s11678-016-0386-9

Cited by 74 publications

(56 citation statements)

References 15 publications

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“…One retrospective non-randomised study of 23 patients (12 with the balloon) showed an improvement in outcomes compared with debridement alone. 27 There are no completed RCTs.…”

Section: Open Accessmentioning

confidence: 99%

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

et al. 2020

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IntroductionShoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.Methods and analysisSubacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.Ethics and disseminationNRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.Trial registration numberISRCTN17825590

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“…One retrospective non-randomised study of 23 patients (12 with the balloon) showed an improvement in outcomes compared with debridement alone. 27 There are no completed RCTs.…”

Section: Open Accessmentioning

confidence: 99%

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

et al. 2020

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“…The implanted balloon allows for frictionless gliding of the humeral head in the subacromial space and reduces pain, ultimately restoring the biomechanics of the glenohumeral joint. 65 66) …”

Section: Biodegradable Subacromial Spacer Insertionmentioning

confidence: 99%

Treatment Strategy for Irreparable Rotator Cuff Tears

2018

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Recently, patients with shoulder pain have increased rapidly. Of all shoulder disorders, rotator cuff tears (RCTs) are most prevalent in the middle-aged and older adults, which is the primary reason for shoulder surgery in the population. Some authors have reported that up to 30% of total RCTs can be classified as irreparable due to the massive tear size and severe muscle atrophy. In this review article, we provide an overview of treatment methods for irreparable massive RCTs and discuss proper surgical strategies for RCTs that require operative management.

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“…The spacer deflates iñ10 weeks and completely degrades within 15 months,30 a sufficient period of time to perform physiotherapy program. It is not clear why pain and functional scores continue to improve beyond the period of spacer disintegration.…”

Section: Subacromial Biodegradable Spacermentioning

confidence: 99%

Irreparable rotator cuff tears: challenges and solutions

Novi¹,

Kumar²,

Paladini³

et al. 2018

ORR

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Irreparable rotator cuff tears are common conditions seen by shoulder surgeons, characterized by a torn and retracted tendon associated with muscle atrophy and impaired mobility. Direct fixation of the torn tendon is not possible due to the retracted tendon and lack of healing potential which result in poor outcome. Several treatment options are viable but correct indication is mandatory for a good result, pain improvement, and restoration of shoulder function. Patient can be treated either with a conservative program or surgically when necessary, by different available modalities like arthroscopic debridement, partial reconstruction, subacromial spacer, tendon transfer, and shoulder replacement with reverse prosthesis. The aim of this study was to review literature to give an overview of the available possible solutions, with indications and expected outcomes.

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Subacromial spacer implantation for massive rotator cuff tears

Cited by 74 publications

References 15 publications

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

Treatment Strategy for Irreparable Rotator Cuff Tears

Irreparable rotator cuff tears: challenges and solutions

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