Autologous Bone Marrow Concentration for Rotator Cuff Tear

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear

Conditions
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Rotator Cuff Tear, Bone Marrow

Intervention / Treatment
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* Other: arthroscopic repair with bone marrow concentration
* Other: arthroscopic repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bone marrow concentration group<br>The patients receive arthroscopic repair with bone marrow concentration. | Other: arthroscopic repair with bone marrow concentration<br>* arthroscopic repair with bone marrow concentration<br>|
| Historical control group<br>The patients receive arthroscopic repair only | Other: arthroscopic repair<br>* arthroscopic repair only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Marrow, Mesenchymal Stromal Cells, Rotator Cuff Tear