Autologous Bone Marrow Concentration for Rotator Cuff Tear

Pei-Yuan Lee, MD

Status: Unknown

Conditions: Rotator Cuff Tear; Bone Marrow

Treatments: Other: arthroscopic repair with bone marrow concentration; Other: arthroscopic repair

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03792594

RD106055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Bone marrow concentration group

Description:

The patients receive arthroscopic repair with bone marrow concentration.

Treatment:

Other: arthroscopic repair with bone marrow concentration

Historical control group

Description:

The patients receive arthroscopic repair only

Treatment:

Other: arthroscopic repair