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| Name | Class |
|---|---|
| Aeon Biotechnology Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone marrow concentration group | The patients receive arthroscopic repair with bone marrow concentration. |
| |
| Historical control group | The patients receive arthroscopic repair only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arthroscopic repair with bone marrow concentration | Other | arthroscopic repair with bone marrow concentration |
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| Measure | Description | Time Frame |
|---|---|---|
| 3-month postoperative shoulder function evaluated by Constant Shoulder Score | Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 3-month postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month postoperative shoulder function evaluated by Constant Shoulder Score | Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 6-month postoperative |
| 12-month postoperative shoulder function evaluated by Constant Shoulder Score |
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Inclusion Criteria:
Exclusion Criteria:
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consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chien-Sheng Lo, MD | Contact | +886-975611289 | johnlcs@gmail.com | |
| Pei-Yuan Lee, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Pei-Yuan Lee, MD | Show Chwan Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Show Chwan Memorial Hospital | Recruiting | Changhua | Changhua | 500 | Taiwan |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| arthroscopic repair | Other | arthroscopic repair only |
|
Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes. |
| 12-month postoperative |
| 3-month postoperative degree of healing evaluated by plain radiograph | Degree of healing evaluated by plain radiograph | 3-month postoperative |
| 6-month postoperative degree of healing evaluated by plain radiograph | Degree of healing evaluated by plain radiograph | 6-month postoperative |
| 12-month postoperative degree of healing evaluated by plain radiograph | Degree of healing evaluated by plain radiograph | 12-month postoperative |
| 6-month postoperative degree of healing evaluated by MRI | Degree of healing evaluated by MRI | 6-month postoperative |
| 12-month postoperative degree of healing evaluated by MRI | Degree of healing evaluated by MRI | 12-month postoperative |