Autologous Bone Marrow Concentration for Rotator Cuff Tear

• Conditions: Rotator Cuff Tear; Bone Marrow
• Interventions: Other: arthroscopic repair with bone marrow concentration; Other: arthroscopic repair

• Registration Number: NCT03792594
• Lead Sponsor: Pei-Yuan Lee, MD

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-05-12
• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-11
• Last Update Posted: 2020-04-14
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bone marrow concentration group	arthroscopic repair with bone marrow concentration	The patients receive arthroscopic repair with bone marrow concentration.
Historical control group	arthroscopic repair	The patients receive arthroscopic repair only

Primary Outcome Measures

Name	Time	Method
3-month postoperative shoulder function evaluated by Constant Shoulder Score	3-month postoperative	Shoulder function is evaluated using Constant Shoulder Score. The survey scores range from 0-100 with higher scores representing less dysfunction and better outcomes.

Secondary Outcome Measures

Name	Time	Method
3-month postoperative degree of healing evaluated by plain radiograph	3-month postoperative	Degree of healing evaluated by plain radiograph
6-month postoperative shoulder function evaluated by Constant Shoulder Score	6-month postoperative	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 shoulder function evaluated by Constant Shoulder Score	12-month postoperative	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 degree of healing evaluated by plain radiograph	6-month postoperative	Degree of healing evaluated by plain radiograph
12-month postoperative degree of healing evaluated by plain radiograph	12-month postoperative	Degree of healing evaluated by plain radiograph
6-month postoperative degree of healing evaluated by MRI	6-month postoperative	Degree of healing evaluated by MRI
12-month postoperative degree of healing evaluated by MRI	12-month postoperative	Degree of healing evaluated by MRI

Trial Locations

Locations (1)

Show Chwan Memorial Hospital; 🇨🇳 Changhua City, Changhua, Taiwan