Poly vs Hybrid Glenoid in Stemless aTSA

Official title

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

Overview

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.

Interventions

• Procedure 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).
• Procedure 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.

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

Inclusion criteria

\-

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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Spaarne Gasthuis — Hoofddorp

Publications

• 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

Identifiers

NCT: NCT07520721 · NL83282.018.23 · 2023.0616

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗