Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- ASES Score
研究概览
简要总结
The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.
详细描述
The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are:
Specific Aim 1:
To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period.
Specific Aim 2:
To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be blinded to their group allocation. This is possible because the incision and rehabilitation processes are consistent between groups. It is not possible for the treating surgeon to be blinded to group allocation, therefore a research team member (athletic or physical therapist) will remain blinded to group allocation and conduct all study related assessments as well as administer the patient-reported questionnaires. This will be maintained by the participant not removing their shirt during the study assessment. Patients will not be informed of which procedure they will undergo until the study is complete.
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
- •Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
- •First RTSA implantation
- •Absence of neoplastic diseases at the treated site
- •Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier < Grade 3) based on pre-operative CT performed as standard of care in the patient group
排除标准
- •Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
- •Avascular necrosis
- •Post-infectious arthritis
- •Proximal humerus fracture
- •Inflammatory arthritis
- •Inability to communicate in English
- •Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.)
- •Intra-operative Exclusions:
- •Subscapularis with fatty infiltration (Goutallier ≥ 3)
- •Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site
- •Any anatomical or patient characteristic that warrants a non-lateralized implant
研究组 & 干预措施
RTSA with subscapularis repair
干预措施: RTSA with subscapularis repair (Procedure)
RTSA without subscapularis repair
干预措施: RTSA without subscapularis repair (Procedure)
结局指标
主要结局
ASES Score
时间窗: 24 months post-operative
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
次要结局
- EQ5D-3L(24 months, post-operative)
- Range of Motion(24 months, post-operative)
- SANE Score(24 months post-operative)
- Constant Score(24 months post-operative)
- Isometric Strength(24 months, post-operative)
- ASES Score(12 months, post-operative)
- Constant Score(baseline pre-operative)
- Constant Score(3 months post-operative)
- Constant Score(6 months post-operative)
- Constant Score(12 months post-operative)
- SANE Score(baseline pre-operative)
- SANE Score(3 months post-operative)
- SANE Score(6 months post-operative)
- SANE Score(12 months post-operative)
- EQ5D-3L(baseline, pre-operative)
- EQ5D-3L(3 months, post-operative)
- EQ5D-3L(6 months, post-operative)
- EQ5D-3L(12 months, post-operative)
- Range of Motion(baseline, pre-surgery)
- Range of Motion(3 months, post-operative)
- Range of Motion(6 months, post-operative)
- Range of Motion(12 months, post-operative)
- Isometric Strength(baseline, pre-surgery)
- Isometric Strength(3 months, post-operative)
- Isometric Strength(6 months, post-operative)
- Isometric Strength(12 months, post-operative)
- ASES Score(baseline, pre-operative)
- ASES Score(3 months, post-operative)
- ASES Score(6 months, post-operative)