Poly vs Hybrid Glenoid in Stemless aTSA

Официальное название

A Randomised, Multicentre, Prospective, Non-inferiority Clinical Study Analysing Outcomes of a Cemented Pegged Polyethylene Glenoid Component Versus a Hybrid Polyethylene and Trabecular Titanium Glenoid Component in Patients With Osteoarthritis Treated With an Anatomical SMR Stemless Shoulder Arthroplasty

Обзор

Participants are randomized 1:1 to receive either a cemented all-polyethylene pegged glenoid or a hybrid trabecular titanium-pegged glenoid during anatomic total shoulder arthroplasty. Multicentre, stratified block randomization with variable block sizes; patient- and assessor-blinded.

Вмешательства

• Процедура Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid
  Stemless anatomic total shoulder arthroplasty (SMR system) with a cemented pegged all-polyethylene glenoid (standard fixation concept).
• Процедура Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
  Stemless anatomic total shoulder arthroplasty (SMR system) with a hybrid polyethylene glenoid: porous trabecular titanium central peg intended for bone ingrowth plus cemented peripheral pegs.

Первичные конечные точки

• Constant-Murley Score (shoulder function) [Срок оценки: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.]

Вторичные конечные точки (10)

• Shoulder range of motion [Срок оценки: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.]
• Oxford Shoulder Score questionnaire [Срок оценки: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.]
• Hospital Anxiety subscale questionnaire [Срок оценки: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.]
• Hospital Depression subscale questionnaire [Срок оценки: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.]
• Subjective Shoulder Value Scale [Срок оценки: Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.]
• Health-related quality of life - EuroQol-5D descriptive system [Срок оценки: Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively.]
• Health-related quality of life - EuroQol-5D Visual Analogue Scal [Срок оценки: Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively.]
• Work-Related Questionnaire for Upper Extremity Disorders [Срок оценки: Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.]
• Work Ability (single-item Work Ability Score) numeric scale [Срок оценки: Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.]
• Implant survival (radiographic loosening endpoint) [Срок оценки: Up to 10 years postoperatively.]

Критерии участия

Критерии включения

\-

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Both genders;
• Age 18 years old;
• Life expectancy over 5 years;
• Patient has symptomatic shoulder osteoarthritis for more than 1 year and is submitted to previous conservative non-surgical treatments;
• Patient is requiring primary unilateral or staged bilateral anatomic arthroplasty based on physical examination, medical history and X ray examination. (In cases where bilateral aTSA's are indicated, the patient will be included for the second aTSA again when the patient meets the inclusion criteria);
• Good bone quality evaluated by the investigator on the basis of a risk factors analysis and the intraoperative estimation;
• A diagnosis in the target shoulder of osteoarthritis; according to the classification of Walch, the glenoid should be a type A1, A2 or B1. Retroversion should not exceed 15 degrees.
• Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;
• Patient has participated in the Informed Consent process and has signed the Informed Consent form previously approved by the Ethics Committee.

Критерии исключения

• Patient requiring revision shoulder arthroplasty;
• Osteoporosis with a history of non-traumatic fractures;
• Steroid injections within the previous 6 months;
• Contralateral shoulder replacement within the previous 3 months;
• Meta-epiphyseal bony defect (including large cysts);
• Significant proven or suspicious infection of the target shoulder or any serious infectious disease
• Significant neurological or musculoskeletal disorders that may compromise functional recovery;
• Known or suspicious hypersensitivity to the metal or other materials of the implant;
• Unwillingness or inability (i.e. alcoholism, infirmity) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;
• Any systemic disease which may affect outcome.
• Active or metastatic neoplastic disease
• Chemotherapy and/or radiotherapy within the last 6 months
• Previous organ transplant
• Participation in any clinical research study that may interfere with this study
• A current or prior DSM-5 diagnosis of schizophrenia, delusional disorder, schizoaffective disorder, psychotic disorder or bipolar disorder.
• Current substance use disorder (excluding nicotine/tabacco use disorder) or moderate or severe alcohol use disorder.
• Imminent suicide risk.
• Any other psychiatric condition that renders the individual unsuitable for the study according to the study physicians judgment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Spaarne Gasthuis — Hoofddorp

Публикации

• Sheikhzadeh A, Wertli MM, Weiner SS, Rasmussen-Barr E, Weiser S. Do psychological factors affect outcomes in musculoskeletal shoulder disorders? A systematic review. BMC Musculoskelet Disord. 2021 Jun 19;22(1):560. doi: 10.1186/s12891-021-04359-6. PMID 34147071
• Lazarus MD, Jensen KL, Southworth C, Matsen FA 3rd. The radiographic evaluation of keeled and pegged glenoid component insertion. J Bone Joint Surg Am. 2002 Jul;84(7):1174-82. doi: 10.2106/00004623-200207000-00013. PMID 12107318
• Youderian AR, Ricchetti ET, Drews M, Iannotti JP. Determination of humeral head size in anatomic shoulder replacement for glenohumeral osteoarthritis. J Shoulder Elbow Surg. 2014 Jul;23(7):955-63. doi: 10.1016/j.jse.2013.09.005. Epub 2013 Dec 8. PMID 24321169
• Beck S, Martin RJ, Patsalis T, Burggraf M, Busch A, Landgraeber S, Alexander W. Determination of humeral inclination in stemless shoulder arthroplasty using plain radiographs. Orthop Rev (Pavia). 2019 Dec 2;11(4):8194. doi: 10.4081/or.2019.8194. eCollection 2019 Dec 2. PMID 31897278
• Werthel JD, Boux de Casson F, Burdin V, Athwal GS, Favard L, Chaoui J, Walch G. CT-based volumetric assessment of rotator cuff muscle in shoulder arthroplasty preoperative planning. Bone Jt Open. 2021 Jul;2(7):552-561. doi: 10.1302/2633-1462.27.BJO-2021-0081.R1. PMID 34315280
• Bercik MJ, Kruse K 2nd, Yalizis M, Gauci MO, Chaoui J, Walch G. A modification to the Walch classification of the glenoid in primary glenohumeral osteoarthritis using three-dimensional imaging. J Shoulder Elbow Surg. 2016 Oct;25(10):1601-6. doi: 10.1016/j.jse.2016.03.010. Epub 2016 Jun 6. PMID 27282738
• Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2. PMID 10512449
• Levin JM, Rodriguez K, Polascik BA, Zeng S, Warren E Jr, Rechenmacher A, Helmkamp J, Goltz DE, Wickman J, Klifto CS, Lassiter TE, Anakwenze O. Simple preoperative radiographic and computed tomography measurements predict adequate bone quality for stemless total shoulder arthroplasty. J Shoulder Elbow Surg. 2022 Dec;31(12):2481-2487. doi: 10.1016/j.jse.2022.05.008. Epub 2022 Jun 4. PMID 35671925

Идентификаторы

NCT: NCT07520721 · NL83282.018.23 · 2023.0616

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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