Bone Marrow, Rotator Cuff Tear
Conditions
Keywords
Bone Marrow, Mesenchymal Stromal Cells, Rotator Cuff Tear
Brief summary
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.
Detailed description
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.
Interventions
OTHERarthroscopic repair with bone marrow concentration
arthroscopic repair with bone marrow concentration
OTHERarthroscopic repair
arthroscopic repair only
Sponsors
Aeon Biotechnology Corporation
Pei-Yuan Lee, MD
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* With diagnosis of rotator cuff tear * Age between 40 and 70 years
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-month postoperative shoulder function evaluated by Constant Shoulder Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-month postoperative shoulder function evaluated by Constant Shoulder Score | 12-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. |
| 3-month postoperative degree of healing evaluated by plain radiograph | 3-month postoperative | Degree of healing evaluated by plain radiograph |
| 6-month postoperative degree of healing evaluated by plain radiograph | 6-month postoperative | Degree of healing evaluated by plain radiograph |
| 6-month postoperative shoulder function evaluated by Constant Shoulder Score | 6-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. |
| 6-month postoperative degree of healing evaluated by MRI | 6-month postoperative | Degree of healing evaluated by MRI |
| 12-month postoperative degree of healing evaluated by MRI | 12-month postoperative | Degree of healing evaluated by MRI |
| 12-month postoperative degree of healing evaluated by plain radiograph | 12-month postoperative | Degree of healing evaluated by plain radiograph |
Countries
Taiwan
Contacts
Primary ContactChien-Sheng Lo, MD
Backup ContactPei-Yuan Lee, MD
Outcome results
None listed