The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 3-month postoperative shoulder function evaluated by Constant Shoulder Score
研究概览
简要总结
This study aims to evaluate the effect of bone marrow concentration on healing of rotator cuff tear by comparing clinical and imaging outcomes between patients receiving arthroscopic repair with intraoperative bone marrow concentration and those receiving arthroscopic repair only.
详细描述
Rotator cuff tear is a common cause of pain and disability among adults. Most tears are largely caused by the normal wear and tear that goes along with aging. Although nonsurgical treatment relieves pain and improves function in the shoulder, surgical repair for a torn rotator cuff is indicated if symptoms persisted or deteriorated after 3 months nonsurgical treatments, Recently, arthroscopic repair has become the mainstream of surgical repair for rotator cuff tear. However, the healing of a repaired tendon is not always predictable. Mesenchymal stem cells (MSCs) are pluripotent cells that can differentiate into multiple mesenchymal tissues, including tenocytes, chondrocytes and osteoblasts, as well as being a source of multiple growth factors to establish an environment conducive to soft and hard tissue regeneration. As bone marrow concentration has high concentration of mesenchymal stem cells, some studies have shown that autologous bone marrow concentration can improve the healing of tendon grafts in a bone tunnel. Therefore, the goal of this study was to evaluate the effect of bone marrow concentration on healing of rotator cuff.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With diagnosis of rotator cuff tear
- •Age between 40 and 70 years
排除标准
- •With prior history of shoulder surgery
- •With current or prior history of trauma or infection at shoulder
- •With current diagnosis of coagulopathy
- •With current or prior history of cancer
- •With current or prior history of hematological disease
- •Pregnancy
- •Patients who will not cooperate with one-year followup
结局指标
主要结局
3-month postoperative shoulder function evaluated by Constant Shoulder Score
时间窗: 3-month postoperative
Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
次要结局
- 3-month postoperative degree of healing evaluated by plain radiograph(3-month postoperative)
- 6-month postoperative shoulder function evaluated by Constant Shoulder Score(6-month postoperative)
- 12-month postoperative shoulder function evaluated by Constant Shoulder Score(12-month postoperative)
- 6-month postoperative degree of healing evaluated by plain radiograph(6-month postoperative)
- 12-month postoperative degree of healing evaluated by plain radiograph(12-month postoperative)
- 6-month postoperative degree of healing evaluated by MRI(6-month postoperative)
- 12-month postoperative degree of healing evaluated by MRI(12-month postoperative)
研究者
Pei-Yuan Lee, MD
Superintendent
Show Chwan Memorial Hospital