Autologous Bone Marrow Concentration for Rotator Cuff Tear
The Effect of Autologous Bone Marrow Concentration Combined With Arthroscopy for Rotator Cuff Tear
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2017
CompletedFirst Submitted
Initial submission to the registry
January 2, 2019
CompletedFirst Posted
Study publicly available on registry
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 14, 2020
April 1, 2020
3.6 years
January 2, 2019
April 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
6-month postoperative shoulder function evaluated by Constant Shoulder Score
6-month postoperative
12-month postoperative shoulder function evaluated by Constant Shoulder Score
12-month postoperative
3-month postoperative degree of healing evaluated by plain radiograph
3-month postoperative
6-month postoperative degree of healing evaluated by plain radiograph
6-month postoperative
12-month postoperative degree of healing evaluated by plain radiograph
12-month postoperative
- +2 more secondary outcomes
Study Arms (2)
Bone marrow concentration group
The patients receive arthroscopic repair with bone marrow concentration.
Historical control group
The patients receive arthroscopic repair only
Interventions
arthroscopic repair with bone marrow concentration
Eligibility Criteria
consecutive eligible patients who underwent arthroscopic repair combined with autologous bone marrow stem cells treatment for rotator cuff tear
You may qualify if:
- With diagnosis of rotator cuff tear
- Age between 40 and 70 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pei-Yuan Lee, MDlead
- Aeon Biotechnology Corporationcollaborator
Study Sites (1)
Show Chwan Memorial Hospital
Changhua, Changhua, 500, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pei-Yuan Lee, MD
Show Chwan Memorial Hospital
Central Study Contacts
Pei-Yuan Lee, MD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Superintendent
Study Record Dates
First Submitted
January 2, 2019
First Posted
January 3, 2019
Study Start
May 12, 2017
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 14, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share