Safety and Efficacy of Platelet-Rich Plasma Combined With Compound Betamethasone in Arthroscopic Surgery for Rotator Cuff Injury With Shoulder Adhesion: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Constant-Murley Shoulder Score
研究概览
简要总结
Background: Patients undergoing arthroscopic surgery for rotator cuff tears with shoulder adhesion often experience significant postoperative pain and stiffness. This study investigates whether adding a long-acting local anesthetic (Liposomal Bupivacaine) to a standard anti-inflammatory steroid injection (Compound Betamethasone) during surgery can improve outcomes.
Methods: This is a prospective, randomized, double-blind, controlled trial. Approximately 70 eligible adult patients will be randomly assigned to one of two groups: (1) the Combination Group, receiving an intra-articular injection of Liposomal Bupivacaine plus Compound Betamethasone after surgery, or (2) the Control Group, receiving Compound Betamethasone alone. Patients and outcome assessors will not know the group assignment.
What participants will do: All participants will receive standard arthroscopic rotator cuff repair and adhesion release. They will be followed for 12 months after surgery, with assessments at multiple time points (from hours to months post-op) to measure pain levels, shoulder function, range of motion, and tendon healing via MRI.
Main Goals: The primary goal is to compare the improvement in UCLA shoulder scores between the two groups at 12 months. Secondary goals include comparing pain scores, other functional scores (Constant-Murley), joint mobility, MRI findings, and safety (complication rates).
详细描述
Study Design: A prospective, randomized, double-blind, parallel-group, active-controlled clinical trial conducted at The Second Affiliated Hospital of Nanchang University.
Participants & Sample Size: 70 patients (35 per group) with full-thickness rotator cuff tear and concomitant shoulder adhesion scheduled for arthroscopic repair. Sample size was calculated based on an expected difference in UCLA scores with 80% power and α=0.05, accounting for a 20% dropout rate.
Interventions:
Combination Therapy Group: After standard arthroscopic rotator cuff repair and capsular release, the shoulder joint will be injected with a mixture of Liposomal Bupivacaine and Compound Betamethasone under direct visualization.
Active Control Group: After the same surgical procedure, the joint will be injected with Compound Betamethasone alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The injection syringes will be prepared by a research pharmacist or designated staff member not involved in patient assessment. Both the experimental (PRP + Compound Betamethasone) and control (normal saline placebo) injections will be identical in appearance (color and volume). Participants, surgeons, postoperative care providers, and outcome assessors will all be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years.
- •Clinical and MRI diagnosis of full-thickness rotator cuff tear.
- •Presence of shoulder stiffness/adhesion defined as passive range of motion less than 100° in forward flexion and/or less than 10° in external rotation (or according to your specific definition).
- •Scheduled for arthroscopic rotator cuff repair and capsular release.
- •Willing and able to provide written informed consent.
- •Willing to comply with all study procedures and follow-up visits.
排除标准
- •Massive, irreparable rotator cuff tear.
- •Severe glenohumeral osteoarthritis (Grade III or IV according to Samilson-Prieto classification).
- •History of shoulder infection, fracture, or previous surgery on the affected shoulder.
- •Known allergy or contraindication to betamethasone, local anesthetics, or components of PRP preparation.
- •Systemic inflammatory arthritis (e.g., rheumatoid arthritis).
- •Coagulation disorders or use of anticoagulants that cannot be safely suspended perioperatively.
- •Pregnancy or lactation.
- •Participation in another clinical trial within the past 3 months.
- •Any medical or psychiatric condition that, in the investigator's opinion, would compromise patient safety or compliance with the study protocol.
研究组 & 干预措施
Combination Therapy Group
Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Liposomal Bupivacaine combined with Compound Betamethasone.
干预措施: Liposomal Bupivacaine + Compound Betamethasone Injection (Drug)
Monotherapy (Control) Group
Participants will receive arthroscopic rotator cuff repair and adhesion release, followed by an intra-articular injection of Compound Betamethasone alone.
干预措施: Compound Betamethasone Injection (Drug)
结局指标
主要结局
Change in Constant-Murley Shoulder Score
时间窗: Baseline, 3 months, and 12 months postoperatively.
The Constant-Murley score is a composite outcome measure assessing shoulder pain, activities of daily living, range of motion, and strength. Scores range from 0 to 100, with higher scores indicating better function.
Visual Analog Scale (VAS) Pain Score at Rest
时间窗: Baseline, 3 months, and 12 months postoperatively.
Pain intensity at rest measured on a 100-mm Visual Analog Scale, where 0 mm represents "no pain" and 100 mm represents "worst pain imaginable."
次要结局
- Active Range of Motion (ROM)(Baseline, 3 months, and 12 months postoperatively.)
- American Shoulder and Elbow Surgeons (ASES) Score(Baseline, 3 months, and 12 months postoperatively.)
- MRI Assessment of Tendon Healing(3 months and 12 months postoperatively.)
- Incidence of Treatment-Related Adverse Events(From the time of surgery up to 12 months postoperatively.)