NCT07520721招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Constant-Murley Score (shoulder function)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 B
- •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.
排除标准
- •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
研究组 & 干预措施
Standard cemented all-polyethylene pegged glenoid
Active Comparator
Anatomic total shoulder arthroplasty (SMR stemless) with a cemented all-polyethylene pegged glenoid.
干预措施: Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid (Procedure)
Hybrid trabecular titanium central-peg glenoid
Experimental
Hybrid trabecular titanium central-peg glenoid
干预措施: Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid (Procedure)
结局指标
主要结局
Constant-Murley Score (shoulder function)
时间窗: Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.
Clinical shoulder function assessed with the Constant-Murley Score (absolute and age/sex-adjusted) comparing hybrid versus standard glenoid fixation after anatomic total shoulder arthroplasty. The Constant-Murley Score ranges from 0 to 100 points, with 0 indicating the worst outcome and 100 indicating the best shoulder function.
次要结局
- Shoulder range of motion(Preoperatively, 3 months; 1, 2, 5, 7, and 10 years postoperatively.)
- Oxford Shoulder Score questionnaire(Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.)
- Hospital Anxiety subscale questionnaire(Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.)
- Hospital Depression subscale questionnaire(Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.)
- Subjective Shoulder Value Scale(Preoperatively; 3 months; 1, 2, 5, 7, and 10 years postoperatively.)
- Health-related quality of life - EuroQol-5D descriptive system(Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively.)
- Health-related quality of life - EuroQol-5D Visual Analogue Scal(Preoperatively; 3 months, 1, 2, 5, 7, and 10 years postoperatively.)
- Work-Related Questionnaire for Upper Extremity Disorders(Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.)
- Work Ability (single-item Work Ability Score) numeric scale(Preoperatively, 6 weeks, 3 months, 6 months, 1, 2, 5, 7, and 10 years postoperatively.)
- Implant survival (radiographic loosening endpoint)(Up to 10 years postoperatively.)
研究者
研究点 (1)
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