Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- The Visual Analog Scale score
研究概览
简要总结
The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.
详细描述
This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.
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
Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bursal-side partial-thickness rotator cuff tears (BPTRCTs) revealed by magnetic resonance imaging (MRI)
- •Failed of conservative treatment for more than 3 months
- •Intraoperative arthroscopic confirmed that the tear was Ellman grade II
排除标准
- •Previous surgical surgery on the shoulder
- •Articular-side or intratendinous rotator cuff tears
- •Combined articular-side partial-thickness rotator cuff tears(APRCTs) and Bursal-side partial-thickness rotator cuff tears (BPRCTs), or full-thickness rotator cuff tears (RCTs)
- •Combined with other shoulder lesions that need to be addressed, such as biceps tendon disorders, labral tears
- •The presence of other diseases that affect shoulder function
- •Contraindication to arthroscopic surgery or anesthesia
研究组 & 干预措施
debridement group
For the debridement group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic debridement will be performed.
干预措施: arthroscopic debridement (Procedure)
repair group
For the repair group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic repair will be performed.
干预措施: arthroscopic repair (Procedure)
结局指标
主要结局
The Visual Analog Scale score
时间窗: Postoperative 18 months
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Constant-Murray Shoulder score
时间窗: postoperative 18 months
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
American Shoulder and Elbow Surgeon score
时间窗: postoperative 18 months
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
University of California-Los Angeles score
时间窗: postoperative 18 months
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
The Visual Analog Scale score
时间窗: Baseline
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
The Visual Analog Scale score
时间窗: Postoperative 6 months
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
The Visual Analog Scale score
时间窗: Postoperative 12 months
Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
Constant-Murray Shoulder score
时间窗: Baseline
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints. Possible scores range from 0 to 100，a higher score means a better result.
Constant-Murray Shoulder score
时间窗: postoperative 6 months
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
Constant-Murray Shoulder score
时间窗: postoperative 12 months
An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.
American Shoulder and Elbow Surgeon score
时间窗: Baseline
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
American Shoulder and Elbow Surgeon score
时间窗: postoperative 6 months
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
American Shoulder and Elbow Surgeon score
时间窗: postoperative 12 months
The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function.
University of California-Los Angeles score
时间窗: Baseline
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
University of California-Los Angeles score
时间窗: postoperative 6 months
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
University of California-Los Angeles score
时间窗: postoperative 12 months
The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.
次要结局
- Grading of fatty degeneration(18 months after surgery)
- Grading of rotator cuff integrity(18 months after surgery)
- Grading of muscle atrophy(18 months after surgery)