Autologous Bone Marrow Concentration for Rotator Cuff Tear

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-12

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Rotator Cuff Tear Bone Marrow

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Bone marrow concentration group

The patients receive arthroscopic repair with bone marrow concentration.

arthroscopic repair with bone marrow concentration

Intervention Type OTHER

arthroscopic repair with bone marrow concentration

Historical control group

The patients receive arthroscopic repair only

arthroscopic repair

Intervention Type OTHER

arthroscopic repair only

Interventions

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arthroscopic repair with bone marrow concentration

Intervention Type OTHER

arthroscopic repair

arthroscopic repair only

Intervention Type OTHER

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No