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Autologous Bone Marrow Concentration for Rotator Cuff Tear

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ClinicalTrials.gov Identifier: NCT03792594
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Aeon Biotechnology Corporation
Information provided by (Responsible Party):
Pei-Yuan Lee, MD, Show Chwan Memorial Hospital

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.

Condition or disease Intervention/treatment
Rotator Cuff Tear Bone Marrow 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear
Actual Study Start Date : May 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

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




Primary Outcome Measures :
  1. 3-month postoperative shoulder function evaluated by Constant Shoulder Score [ Time Frame: 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 :
  1. 6-month postoperative shoulder function evaluated by Constant Shoulder Score [ Time Frame: 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.

  2. 12-month postoperative shoulder function evaluated by Constant Shoulder Score [ Time Frame: 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.

  3. 3-month postoperative degree of healing evaluated by plain radiograph [ Time Frame: 3-month postoperative ]
    Degree of healing evaluated by plain radiograph

  4. 6-month postoperative degree of healing evaluated by plain radiograph [ Time Frame: 6-month postoperative ]
    Degree of healing evaluated by plain radiograph

  5. 12-month postoperative degree of healing evaluated by plain radiograph [ Time Frame: 12-month postoperative ]
    Degree of healing evaluated by plain radiograph

  6. 6-month postoperative degree of healing evaluated by MRI [ Time Frame: 6-month postoperative ]
    Degree of healing evaluated by MRI

  7. 12-month postoperative degree of healing evaluated by MRI [ Time Frame: 12-month postoperative ]
    Degree of healing evaluated by MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792594


Contacts
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Contact: Chien-Sheng Lo, MD +886-975611289 johnlcs@gmail.com
Contact: Pei-Yuan Lee, MD

Locations
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Taiwan
Show Chwan Memorial Hospital Recruiting
Changhua City, Changhua, Taiwan, 500
Contact: Chien-Sheng Lo, MD    +886-975611289    johnlcs@gmail.com   
Sponsors and Collaborators
Pei-Yuan Lee, MD
Aeon Biotechnology Corporation
Investigators
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Study Chair: Pei-Yuan Lee, MD Show Chwan Memorial Hospital

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Responsible Party: Pei-Yuan Lee, MD, Superintendent, Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT03792594     History of Changes
Other Study ID Numbers: RD106055
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pei-Yuan Lee, MD, Show Chwan Memorial Hospital:
Bone Marrow
Mesenchymal Stromal Cells
Rotator Cuff Tear
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries