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Implant migration and functional outcome of Reverse Shoulder Lateralized Glenosphere Line Extension System : a study protocol for a randomized controlled trial

Jensen, Marie Louise ; Olsen, Bo S. ; Nyring, Marc R.K. ; Yilmaz, Müjgan ; Petersen, Michael M. ; Flivik, Gunnar LU and Rasmussen, Jeppe V. (2022) In Trials 23(1).
Abstract

Background: Inferior scapular notching is a complication unique to reverse shoulder arthroplasty. The most efficient technique to avoid inferior scapular notching has been reported to be lateralization of the glenoid offset. This study aims to compare radiological and functional outcomes of the DELTA Xtend® Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the Standard DELTA Xtend® Reverse Shoulder System (control group). We hypothesize that the lateralization improves the patient outcome by decreasing the risk of inferior scapular notching without increasing the risk of migration and loosening of glenoid component. Methods: In this randomized controlled trial, all Danish citizens with rotator cuff... (More)

Background: Inferior scapular notching is a complication unique to reverse shoulder arthroplasty. The most efficient technique to avoid inferior scapular notching has been reported to be lateralization of the glenoid offset. This study aims to compare radiological and functional outcomes of the DELTA Xtend® Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the Standard DELTA Xtend® Reverse Shoulder System (control group). We hypothesize that the lateralization improves the patient outcome by decreasing the risk of inferior scapular notching without increasing the risk of migration and loosening of glenoid component. Methods: In this randomized controlled trial, all Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear and allocated for a reverse total shoulder arthroplasty at the department of orthopaedic surgery at Herlev and Gentofte Hospital, Copenhagen University Hospital, will be considered for participation. The exclusion criteria are as follows: below 50 years of age, cognitive or linguistic impairment, insufficient glenoid bone stock, previous fracture in the upper extremity and autoimmune-mediated inflammatory arthritis. There will be included a total of 122 patients of which 56 will participate in the radiostereometric analysis. This number of patients allows 20% to drop out. The co-primary outcomes are the pattern and magnitude of the migration of the glenoid component assessed by radiostereometric analysis and the Western Ontario Osteoarthritis of the Shoulder index. The secondary outcomes are inferior scapular notching, patient-reported and functional outcomes (Oxford shoulder score, Constant-Murley score and pain), side effects and complications, changes in bone mineral density and economy. The included patients will be examined before the surgery, within 1 week and 3, 6, 12 and 24 months after. Discussion: No previous studies have compared the conventional reverse shoulder arthroplasty with the lateralized reverse shoulder arthroplasty in a randomized controlled trial regarding migration and functional outcome. Furthermore, radiostereometric analysis has not been used to evaluate the migration of reverse shoulder arthroplasty in a randomized controlled trial. This study intends to determine which treatment has the most optimal outcome for the benefit of future patients with an indication for reverse shoulder arthroplasty. Trial registration: The study has been notified to Pactius and has approval number P-2021-231. Furthermore, the study will be registered on Clinicaltrials.gov before starting the inclusion.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Clinical outcome, Lateralized glenosphere, Radiostereometric analysis, Reverse shoulder arthroplasty, Rotator cuff arthropathy, Scapular notching
in
Trials
volume
23
issue
1
article number
579
publisher
BioMed Central (BMC)
external identifiers
  • pmid:35854390
  • scopus:85134380397
ISSN
1745-6215
DOI
10.1186/s13063-022-06482-8
language
English
LU publication?
yes
id
4a1fad04-af10-4c3a-8a0e-d740c1fc704f
date added to LUP
2022-09-21 15:22:29
date last changed
2024-04-04 13:44:59
@article{4a1fad04-af10-4c3a-8a0e-d740c1fc704f,
  abstract     = {{<p>Background: Inferior scapular notching is a complication unique to reverse shoulder arthroplasty. The most efficient technique to avoid inferior scapular notching has been reported to be lateralization of the glenoid offset. This study aims to compare radiological and functional outcomes of the DELTA Xtend® Reverse Shoulder System Lateralized Glenosphere Line Extension (intervention group) with the Standard DELTA Xtend® Reverse Shoulder System (control group). We hypothesize that the lateralization improves the patient outcome by decreasing the risk of inferior scapular notching without increasing the risk of migration and loosening of glenoid component. Methods: In this randomized controlled trial, all Danish citizens with rotator cuff arthropathy or degeneration of the glenohumeral joint with severe posterior wear and allocated for a reverse total shoulder arthroplasty at the department of orthopaedic surgery at Herlev and Gentofte Hospital, Copenhagen University Hospital, will be considered for participation. The exclusion criteria are as follows: below 50 years of age, cognitive or linguistic impairment, insufficient glenoid bone stock, previous fracture in the upper extremity and autoimmune-mediated inflammatory arthritis. There will be included a total of 122 patients of which 56 will participate in the radiostereometric analysis. This number of patients allows 20% to drop out. The co-primary outcomes are the pattern and magnitude of the migration of the glenoid component assessed by radiostereometric analysis and the Western Ontario Osteoarthritis of the Shoulder index. The secondary outcomes are inferior scapular notching, patient-reported and functional outcomes (Oxford shoulder score, Constant-Murley score and pain), side effects and complications, changes in bone mineral density and economy. The included patients will be examined before the surgery, within 1 week and 3, 6, 12 and 24 months after. Discussion: No previous studies have compared the conventional reverse shoulder arthroplasty with the lateralized reverse shoulder arthroplasty in a randomized controlled trial regarding migration and functional outcome. Furthermore, radiostereometric analysis has not been used to evaluate the migration of reverse shoulder arthroplasty in a randomized controlled trial. This study intends to determine which treatment has the most optimal outcome for the benefit of future patients with an indication for reverse shoulder arthroplasty. Trial registration: The study has been notified to Pactius and has approval number P-2021-231. Furthermore, the study will be registered on Clinicaltrials.gov before starting the inclusion.</p>}},
  author       = {{Jensen, Marie Louise and Olsen, Bo S. and Nyring, Marc R.K. and Yilmaz, Müjgan and Petersen, Michael M. and Flivik, Gunnar and Rasmussen, Jeppe V.}},
  issn         = {{1745-6215}},
  keywords     = {{Clinical outcome; Lateralized glenosphere; Radiostereometric analysis; Reverse shoulder arthroplasty; Rotator cuff arthropathy; Scapular notching}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Implant migration and functional outcome of Reverse Shoulder Lateralized Glenosphere Line Extension System : a study protocol for a randomized controlled trial}},
  url          = {{http://dx.doi.org/10.1186/s13063-022-06482-8}},
  doi          = {{10.1186/s13063-022-06482-8}},
  volume       = {{23}},
  year         = {{2022}},
}