An observational study in Rotator Cuff Tear and Bone Marrow, sponsored by Pei-Yuan Lee, MD. Status unknown at 1 site in Taiwan. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-04-14.
Sponsored by Pei-Yuan Lee, MD · Observational
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's planned enrollment of 40 is below the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Pei-Yuan Lee, MD is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear
Exclusion Criteria:
The patients receive arthroscopic repair with bone marrow concentration.
Other: arthroscopic repair with bone marrow concentration
The patients receive arthroscopic repair only
Other: arthroscopic repair
arthroscopic repair with bone marrow concentration
arthroscopic repair only
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.
Time frame: 3-month postoperative
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.
Time frame: 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.
Time frame: 12-month postoperative
3-month postoperative degree of healing evaluated by plain radiograph
Degree of healing evaluated by plain radiograph
Time frame: 3-month postoperative
6-month postoperative degree of healing evaluated by plain radiograph
Degree of healing evaluated by plain radiograph
Time frame: 6-month postoperative
12-month postoperative degree of healing evaluated by plain radiograph
Degree of healing evaluated by plain radiograph
Time frame: 12-month postoperative
6-month postoperative degree of healing evaluated by MRI
Degree of healing evaluated by MRI
Time frame: 6-month postoperative
12-month postoperative degree of healing evaluated by MRI
Degree of healing evaluated by MRI
Time frame: 12-month postoperative
Plan to share: No
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This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Pei-Yuan Lee, MD