Autologous Bone Marrow Concentration for Rotator Cuff Tear

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792594
• Other study ID #: RD106055
• Status: Recruiting
• Start date: May 12, 2017
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Show Chwan Memorial Hospital
• Contact: Chien-Sheng Lo, MD
• Phone: +886-975611289
• Email: johnlcs[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow
• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Other:
• arthroscopic repair with bone marrow concentration
arthroscopic repair with bone marrow concentration
• arthroscopic repair
arthroscopic repair only

Locations

Country	Name	City	State
Taiwan	Show Chwan Memorial Hospital	Changhua City	Changhua

Sponsors (2)

Lead Sponsor	Collaborator
Pei-Yuan Lee, MD	Aeon Biotechnology Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	3-month postoperative degree of healing evaluated by plain radiograph	Degree of healing evaluated by plain radiograph	3-month postoperative
Secondary	6-month postoperative degree of healing evaluated by plain radiograph	Degree of healing evaluated by plain radiograph	6-month postoperative
Secondary	12-month postoperative degree of healing evaluated by plain radiograph	Degree of healing evaluated by plain radiograph	12-month postoperative
Secondary	6-month postoperative degree of healing evaluated by MRI	Degree of healing evaluated by MRI	6-month postoperative
Secondary	12-month postoperative degree of healing evaluated by MRI	Degree of healing evaluated by MRI	12-month postoperative