A MULTICENTRE, RANDOMIZED, CONTROLLED TRIAL COMPARING A SECOND-GENERATION UNCEMENTED TRABECULAR METAL-BACKED WITH A CEMENTED POLYETHYLENE GLENOID COMPONENT IN TOTAL SHOULDER ARTHROPLASTY: FIVE-YEAR RESULTS
Notice bibliographique
Résumé
Previously, we reported early findings (two-year) from a randomized controlled trial comparing a second-generation uncemented trabecular metal (TM) glenoid versus cemented polyethylene glenoid (POLY) in patients undergoing a total shoulder arthroplasty (TSA). The purpose of the current study is to report medium-term (five-year) results from this trial. Approval to conduct this multi-centre randomized trial was obtained from the appropriate institutional ethics boards. Five fellowship-trained surgeons from three centres participated. Patients 18–79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Ineligibility criteria included: significant glenoid bone loss; major joint trauma; avascular necrosis; chronic dislocation; rotator cuff or inflammatory arthropathy; massive rotator cuff tear; previous shoulder surgery; muscle paralysis; Charcot arthropathy; life expectancy Of the 104 patients consented, 93 were randomized (46 TM; 47 POLY). There were no group differences at baseline (TM: 66.5yo (SD6.4); 24M/22F and POLY: 68.4yo (SD5.5); 23M/24F). No significant or clinically important differences were found with patient-reported outcomes, range of motion, or strength between groups at five-years postoperative. All outcomes in both groups improved significantly from baseline however, only minor improvements were observed between two- and five-years. With respect to the primary outcome (WOOS), the mean (SD) scores at baseline, two- and five-years were: TM: 32 (21), 92 (13), 93 (11) and POLY: 27 (15), 93 (11) and 93 (10), respectively. Metal debris was observed in 11 (23.9%) patients, but outcomes were not negatively impacted. Debris severity was minor (Grade 1 = 9pts; Grade 2 = 2pts) and remained stable in all but one patient who progressed from Grade 1 (years two-four) to Grade 2 in year five. Seven patients in each group experienced a complication. Of these, 6 (13%) in the TM and 4 (8.5%) in the POLY required a re-operation or revision. Only one patient experienced a glenoid-related complication requiring revision; this patient was in the TM group and had glenoid loosening due to infection. No catastrophic glenoid implant failures were observed. At five-years postoperative, there were no statistically or clinically significant differences between the two implants with respect to patient-reported outcomes, shoulder function, and complication rates. There were no catastrophic failures of the second-generation TM glenoid component. Metal debris was observed in 23.9% of patients with a TM glenoid but did not negatively influence implant survival, patient-reported outcomes, or shoulder function.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,006 | 0,007 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,004 | 0,004 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,002 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,002 | 0,001 |
| Intégrité de la recherche | 0,003 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».