Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis. A Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 296
- 试验地点
- 2
- 主要终点
- Change in American Shoulder and Elbow Surgeons score (ASES)
研究概览
简要总结
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion. The primary goal of our prospective randomized study is to determine whether RTSA have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.
详细描述
Total anatomic shoulder arthroplasty (TSA) is an effective treatment of severe glenohumeral osteoarthritis, with significant improvement in shoulder pain and function. Concerns about glenoid loosening, associated with difficult revision procedures and disappointing outcomes, have however been raised.
Reverse total shoulder arthroplasty (RTSA) was designed with a medialized center of rotation to treat cuff tear arthropathy. Favorable early reports led to the expansion of primary indications of RTSA to proximal humeral fractures as well as osteoarthritis with poor glenoid bone stock. Recent reports revealed excellent clinical results of RTSA for primary glenohumeral arthropathy with intact rotator cuff and a low rate of complications.
Retrospective studies comparing functional results - of anatomic TSA for treating glenohumeral osteoarthritis with RTSA for rotator cuff arthropathy - found equivalent or greater improvements in American Shoulder and Elbow Surgeons score (ASES) at >2-year follow-up. In a study comparing anatomic TSA to RTSA for the treatment of glenohumeral osteoarthritis with intact rotator cuffs, Steen et al. reported equivalent functional results at >2-year follow-up. The retrospective matched cohort study could, however, not eliminate biases, such that RTSA patients had higher preoperative glenoid retroversion than anatomic TSA patients. The authors therefore hypothesize that, in patients treated for glenohumeral osteoarthritis without excessive glenoid retroversion, RTSA will render better functional outcomes than anatomic TSA, at 2 postoperative years. Many other studies confirmed in 2019 Steen's hypothesis. Moreover, several studies revealed good long-term survivorship after RTSA.
There are no published prospective studies that compared 2-year functional outcomes of RTSA and anatomic TSA for the treatment of primary glenohumeral osteoarthritis with intact rotator cuffs and no excessive glenoid retroversion. The primary goal of our prospective randomized study is to determine whether RTSA have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral osteoarthritis, without rotator cuff tears nor significant glenoid retroversion.The secondary goals are 1) to evaluate whether RTSA eventually grants superior postoperative clinical and radiographic outcomes than anatomic TSA (superiority), 2) to determine whether RTSA is associated with fewer postoperative complications than anatomic TSA.
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 (Outcomes Assessor)
盲法说明
While the patients and care providers will be aware of the type of prosthesis, the physicians who assessed the outcomes and analyzed the data will be blinded to this information.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary glenohumeral arthritis,
- •Intact rotator cuff,
- •No important glenoid bone loss (cf
排除标准
- •Patients between 65 and 85 years old
- •Informed Consent as documented by signature (Appendix Informed Consent Form).
- •Exclusion Criteria:
- •B2 glenoid with > 80% posterior humeral head subluxation or greater 25 degrees neoglenoid retroversion,
- •B3 and C type glenoids,
- •Full thickness rotator cuff tear,
- •Acute or malunited proximal humeral fracture,
- •Chronic locked dislocation
- •Rheumatoid arthritis,
- •Revision surgery or surgical antecedents,
- •Axillary nerve damage,
- •Non-functioning deltoid muscle,
- •Glenoid vault deficiency precluding baseplate fixation,
- •Infection and neuropathic joints,
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Patients incapable of judgement or under tutelage,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, contraindication for CT scan etc. of the participant,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
研究组 & 干预措施
Anatomic TSA
The control group will receive through a deltopectoral approach an anatomic total shoulder arthroplasty (TSA) for a primary glenohumeral arthritis
干预措施: Total shoulder arthroplasty (Device)
RTSA
The experimental group will receive through a deltopectoral approach a reverse total shoulder arthroplasty RTSA for a primary glenohumeral arthritis
干预措施: Total shoulder arthroplasty (Device)
结局指标
主要结局
Change in American Shoulder and Elbow Surgeons score (ASES)
时间窗: Between baseline and 2 postoperative years
General clinical score (0-100, with 100 being the best score possible)
次要结局
- Change in Constant score(Between baseline and 2 postoperative years)
- Change in Subjective Shoulder Value (SSV)(Between baseline and 2 postoperative years)
- Change in Short Form -12 (SF-12)(Between baseline and 2 postoperative years)
- Radiographic outcomes(2 postoperative years)
- Change in Range of motion in degrees(Between baseline and 2 postoperative years)
- Complication rates(2 postoperative years.)
- Change in pain on visual analogic scale (pVAS)(Between baseline and 2 postoperative years)
研究者
Dr. Alexandre Lädermann
Principal Investigator
La Tour Hospital