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Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol

BACKGROUND: Optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. A recent meta analysis revealed no difference in strength or functional outcome between treatments. The included studies varied in methodolo...

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Autores principales: van Deurzen, Derek Friedrich Petrus, Scholtes, Vanessa Antoinet Bernice, Willigenburg, Nienke Willemien, Gurnani, Navin, Verweij, Lukas Pieter Eduard, van den Bekerom, Michel Pieter Jozef
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5004307/
https://www.ncbi.nlm.nih.gov/pubmed/27577549
http://dx.doi.org/10.1186/s12891-016-1230-5
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author van Deurzen, Derek Friedrich Petrus
Scholtes, Vanessa Antoinet Bernice
Willigenburg, Nienke Willemien
Gurnani, Navin
Verweij, Lukas Pieter Eduard
van den Bekerom, Michel Pieter Jozef
author_facet van Deurzen, Derek Friedrich Petrus
Scholtes, Vanessa Antoinet Bernice
Willigenburg, Nienke Willemien
Gurnani, Navin
Verweij, Lukas Pieter Eduard
van den Bekerom, Michel Pieter Jozef
author_sort van Deurzen, Derek Friedrich Petrus
collection PubMed
description BACKGROUND: Optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. A recent meta analysis revealed no difference in strength or functional outcome between treatments. The included studies varied in methodological quality, and only two were randomized controlled trials (RCTs). As strong evidence in favor of either tenotomy or tenodesis is still lacking, we designed this randomized controlled trial to compare functional outcomes after tenotomy and tenodesis when performed in adjunct to arthroscopic rotator cuff repair. METHODS: Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3 cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and patient-reported data will be collected pre-operatively, 6 weeks, 3 months and 1 year after surgery. Primary outcome is overall shoulder function evaluated with the Constant score at 1 year after surgery. As additional measures of shoulder function, two patient reported outcomes (the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire) will be assessed. Other evaluations include cosmetic appearance evaluated by the “Popeye” deformity, elbow flexion strength, arm cramping pain, MRI-based location of the biceps tendon, quality of life, and duration of surgery. To detect non-inferiority with a one-sided, two-sample t-test with 80 % power and a significance level (alpha) of 0.025, the required sample size is 98 patients. DISCUSSION: Treatment of LHB tendon lesions is performed differently around the world and meta analyses do not provide conclusive evidence in favor of one of these treatments. This study will strengthen evidence on the risks and benefits of LHB tenotomy and tenodesis in adjunct to a rotator cuff repair, which is important for managing patient expectations. TRIAL REGISTRATION: Dutch Trial Register (NTR3255) January 12, 2012, ClinicalTrials.gov (ID NCT02655848) January 14, 2016, retrospectively registered.
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spelling pubmed-50043072016-08-31 Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol van Deurzen, Derek Friedrich Petrus Scholtes, Vanessa Antoinet Bernice Willigenburg, Nienke Willemien Gurnani, Navin Verweij, Lukas Pieter Eduard van den Bekerom, Michel Pieter Jozef BMC Musculoskelet Disord Study Protocol BACKGROUND: Optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. A recent meta analysis revealed no difference in strength or functional outcome between treatments. The included studies varied in methodological quality, and only two were randomized controlled trials (RCTs). As strong evidence in favor of either tenotomy or tenodesis is still lacking, we designed this randomized controlled trial to compare functional outcomes after tenotomy and tenodesis when performed in adjunct to arthroscopic rotator cuff repair. METHODS: Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3 cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and patient-reported data will be collected pre-operatively, 6 weeks, 3 months and 1 year after surgery. Primary outcome is overall shoulder function evaluated with the Constant score at 1 year after surgery. As additional measures of shoulder function, two patient reported outcomes (the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire) will be assessed. Other evaluations include cosmetic appearance evaluated by the “Popeye” deformity, elbow flexion strength, arm cramping pain, MRI-based location of the biceps tendon, quality of life, and duration of surgery. To detect non-inferiority with a one-sided, two-sample t-test with 80 % power and a significance level (alpha) of 0.025, the required sample size is 98 patients. DISCUSSION: Treatment of LHB tendon lesions is performed differently around the world and meta analyses do not provide conclusive evidence in favor of one of these treatments. This study will strengthen evidence on the risks and benefits of LHB tenotomy and tenodesis in adjunct to a rotator cuff repair, which is important for managing patient expectations. TRIAL REGISTRATION: Dutch Trial Register (NTR3255) January 12, 2012, ClinicalTrials.gov (ID NCT02655848) January 14, 2016, retrospectively registered. BioMed Central 2016-08-30 /pmc/articles/PMC5004307/ /pubmed/27577549 http://dx.doi.org/10.1186/s12891-016-1230-5 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
van Deurzen, Derek Friedrich Petrus
Scholtes, Vanessa Antoinet Bernice
Willigenburg, Nienke Willemien
Gurnani, Navin
Verweij, Lukas Pieter Eduard
van den Bekerom, Michel Pieter Jozef
Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol
title Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol
title_full Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol
title_fullStr Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol
title_full_unstemmed Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol
title_short Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol
title_sort long head biceps tenodesis or tenotomy in arthroscopic rotator cuff repair: bite study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5004307/
https://www.ncbi.nlm.nih.gov/pubmed/27577549
http://dx.doi.org/10.1186/s12891-016-1230-5
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