Autologous Bone Marrow Concentration for Rotator Cuff Tear

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

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.

Study Overview

• Status: Unknown
• Conditions: Rotator Cuff Tear; Bone Marrow
• Intervention / Treatment: Other: arthroscopic repair with bone marrow concentration; Other: arthroscopic repair

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Chien-Sheng Lo, MD; Phone Number: +886-975611289; Email: johnlcs@gmail.com

Study Locations

• Taiwan
  • Changhua
    • Changhua City, Changhua, Taiwan, 500
      • Recruiting
      • Show Chwan Memorial Hospital
      • Contact: Chien-Sheng Lo, MD; Phone Number: +886-975611289; Email: johnlcs@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bone marrow concentration group; The patients receive arthroscopic repair with bone marrow concentration.	Other: arthroscopic repair with bone marrow concentration; arthroscopic repair with bone marrow concentration
Historical control group; The patients receive arthroscopic repair only	Other: arthroscopic repair; arthroscopic repair only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
3-month postoperative degree of healing evaluated by plain radiograph	Degree of healing evaluated by plain radiograph	3-month postoperative
6-month postoperative degree of healing evaluated by plain radiograph	Degree of healing evaluated by plain radiograph	6-month postoperative
12-month postoperative degree of healing evaluated by plain radiograph	Degree of healing evaluated by plain radiograph	12-month postoperative
6-month postoperative degree of healing evaluated by MRI	Degree of healing evaluated by MRI	6-month postoperative
12-month postoperative degree of healing evaluated by MRI	Degree of healing evaluated by MRI	12-month postoperative

Collaborators and Investigators

• Sponsor: Pei-Yuan Lee, MD
• Collaborators: Aeon Biotechnology Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Rotator Cuff Tear; Mesenchymal Stromal Cells; Bone Marrow
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: RD106055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No