Effect of Different Postoperative Rehab Methods on Clinical Outcomes Following Reverse Shoulder Arthroplasty: A Prospective Randomized Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- American shoulder and elbow surgeons score at 6 months following surgery
研究概览
简要总结
Notwithstanding the rapid increase in utilization of reverse total shoulder arthroplasty (RTSA), little consensus or high-quality evidence exists regarding optimal rehab methods following the procedure. Our research question is how different rehab methods influence the clinical outcomes following RTSA. This proposal presents a prospective randomized clinical trial where 100 eligible RTSA patients will be randomly assigned to two rehab groups (Short immobilization with patient-directed therapy vs Long immobilization with supervised therapy) at a single institution. Patient-reported outcomes, objective clinical data, and complications will be compared between the groups over a period of 2 years.
详细描述
The investigators will perform a prospective randomized non-blinded clinical study where the investigators will recruit a total of 100 patients undergoing RTSA at our institution according to the inclusion and exclusion criteria. Participants will be randomly assigned to one of two rehab groups (50 in each group) - short immobilization combined with patient-directed home therapy (Patient-led rehab) vs long immobilization combined with supervised physical therapy (Supervised rehab) - using a randomization protocol developed by our biostatistics department. The group assignment will be kept sealed in an envelope until the day of surgery to blind both the patients and surgeons.
Surgical procedure and postoperative rehabilitation Enrolled patients will undergo RTSA with one of the two shoulder and elbow surgeons under general anesthesia combined with interscalene block. A standard deltopectoral approach will be used, and the subscapularis tendon will be repaired using transosseous sutures if it is reparable. Tornier reverse shoulder arthroplasty system (Ascent Flex humeral stem with 132.5°inclincation angle, standard Perform Reversed glenoid components, and standard polyethylene liner) will be used in all patients. The size of the humeral stem, baseplate, glenosphere, and polyethylene liner will be chosen on the basis of the patient's anatomy. A sling with an abduction pillow will be used for postoperative immobilization in 30° abduction and 45° internal rotation in all patients. The patient-led rehab group will be educated on their postoperative rehab in detail prior to surgery. The detailed rehab methods for each group are as follows.
- Patient-led rehab group Duration of the sling: 1 week in sling with abduction pillow for immobilization; then optional for comfort only Start of shoulder exercise: Within 1 week of surgery once pain subsides Mode of rehab: Patients performing exercises on their own following instructions Phase 1 (3-5 days to 2 weeks): Pendulum, deltoid and periscapular muscle isometric strengthening Phase 2 (2-4 weeks): passive, active assisted motion Phase 3 (4-8 weeks): Active motion Phase 4 (8-12 weeks): Strengthening
- Supervised rehab group Duration of the sling: 4 weeks in sling with abduction pillow for immobilization; then optional for comfort only Start of shoulder exercise: At 4 weeks after surgery Mode of rehab: Patients attending outpatient physical therapy sessions led by therapists Phase 1 (0-4 weeks): Immobilization in sling Phase 2 (4-8 weeks): Passive, active assisted motion Phase 3 (8-12 weeks): Active motin Phase 4 (12-16 weeks): Strengthening
Postoperative outcome evaluation Strict adherence to the rehab protocol will be encouraged and monitored during the rehab period. The research coordinator will contact patients twice a week for the first 2 weeks and then once a week for the following 2 weeks. Patients will be given a pain diary where they will record their pain levels daily along with their daily narcotic use for the first 2 weeks. Patients will return for follow-up, undergo x-rays, and will be evaluated at 2 weeks, 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. The following data will be obtained during the study period.
- Pain measured using a visual analog scale daily for the first 2 weeks; then at each follow-up visit
- Patient-reported outcomes: ASES, QuickDASH, SANE, and PROMIS at each visit except at 2 weeks.
- Range of motion: forward elevation, external rotation, internal rotation at each visit except at 2 weeks
- Radiographic findings of failure such as dislocation, implant dislodgement, migration, or loosening, scapular notching, periprosthetic humuerus fracture, or scapular fracture at any time: Will be included as complications
- Complications such as instability, hematoma, wound healing issue, abnormal level of pain due to rehab method at any time, or reoperation
- Overall patient satisfaction with their rehab method using a 5-point Likert-type scale at 6 months (Question: Were you satisfied with your rehab method? Very unsatisfied, slightly unsatisfied, neutral, somewhat satisfied, very satisfied)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged 18 years or older
- •Diagnosed with rotator cuff arthropathy, glenohumeral osteoarthritis with a > 1.5-cm rotator cuff tear, or massive irreparable rotator cuff tear
- •Have a normal functioning deltoid
- •Have preserved teres minor function (a negative Hornblower's sign)
- •Have failed conservative management for >3 months
排除标准
- •younger than 18 years
- •chronic opiate use history
- •fibromyalgia or other conditions that increase susceptibility to pain
- •preoperative stiffness (definition: < 30 degree passive external rotation, < 90 degree passive forward elevation), neurologic disorder affecting the ipsilateral upper extremity,
- •RTSA for acute proximal humerus fracture or fracture sequelae (nonunion, malunion)
- •previous arthroplasty, fracture fixation, or open rotator cuff procedures in the same shoulder
- •deltoid dysfunction
- •inflammatory glenohumeral arthritis
- •non-English speaking or unable to understand English for consent.
研究组 & 干预措施
Patient-led rehab group
Immobilization in arm sling for a short period time followed by patient-led shoulder exercises for rehab following reverse shoulder arthroplasty
干预措施: Patient-led rehab with short immobilization (Behavioral)
Supervised rehab group
Prolonged immobilization in arm sling followed by supervised physical therapy by therapists for rehab following reverse shoulder arthroplasty
结局指标
主要结局
American shoulder and elbow surgeons score at 6 months following surgery
时间窗: At 6 months following surgery
American shoulder and elbow surgeons score at 6 months; lowest 0 point and highest 100 points; higher scores mean a better outcome
次要结局
- Complications(During the first 2 years following surgery)
研究者
H. Mike Kim
Associate Professor
University of Missouri-Columbia
