Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Sponsor
Rush University Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02981394
Collaborator
(none)
0
1
50
0
Study Details
Study Description
Brief Summary
The use of Bone Marrow Autologous Collection (BMAC) in musculoskeletal conditions including osteoarthritis and tendon injuries has been growing. Outcome evidence continues to be sparse. The purpose of this study is collect a longitudinal case series of patient reported outcomes following BMAC injections for musculoskeletal conditions including osteoarthritis, tendinopathy and injuries to ligaments, tendons and muscles.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational [Patient Registry]
Actual Enrollment
:
0 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Study Start Date
:
Nov 1, 2016
Anticipated Primary Completion Date
:
Jan 1, 2021
Actual Study Completion Date
:
Jan 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| BMAC Group Intervention Group |
Procedure: Bone Marrow Aspirate Concentrate Injection
BMAC will be collected in the outpatient setting with local anesthesia. The collection site will be the Posterior Superior Iliac Spine (PSIS). This will be visualized under ultrasound prior to collection. Local anesthesia with 1% lidocaine will be performed prior to the harvest. BMAC harvest will be performed using the Arthrex Angel BMAC System using the Arthrex collection protocol. The Arthrex Angel machine will be used to separate BMAC contents for injection based on Arthrex collection protocol. Machine settings, volume of collection and volume of output have not been standardized and will be based upon harvest and the condition treated. These will be variables recorded for consideration of optimal settings based on the patient-reported outcomes.
|
Outcome Measures
Primary Outcome Measures
- WOMAC Score [5 years]
Pain and Function Score
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Musculoskeletal Condition that is able to undergo an injection
-
Patient requests the procedure and enrolls with agreement to pay for the procedure
Exclusion Criteria:
-
Active Cancer
-
Allergies to local anesthesia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Midwest Orthopeadics at Rush | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- Rush University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT02981394
Other Study ID Numbers:
- 16090710-IRB01
First Posted:
Dec 5, 2016
Last Update Posted:
May 27, 2021
Last Verified:
May 1, 2021