Cellular Content of Bone Marrow Aspiration, Comparison (BioCuff)

October 6, 2022 updated by: Andrews Research & Education Foundation

Comparison of the Cellular Content of Bone Marrow Aspiration From the Posterior Superior Iliac Spine and Deep Humeral Harvest in Patients Undergoing Rotator Cuff Repair

The goal of this observational clinical trial is to determine whether the posterior superior iliac spine of the hip or the humerus of the arm will produce larger amounts of bone marrow when harvested during surgery. Also, the secondary goal of this study is to determine the effects of the patient's position on the quantity of cells harvested from the hip, namely lying on back (prone) vs. lying on side (lateral decubitus). The main questions it aims to answer are:

  • Will the hip or the arm have more bone marrow extracted?
  • Does a patient lying in lateral decubitus position produce more bone marrow than lying in the prone position?

Participants that are to undergo rotator-cuff repair are eligible for this study. During the participant's repair, bone marrow will be extracted from the arm and from the hip. Half of the eligible participants will have bone marrow extracted from the hip while lying on their side, while the other half will have bone marrow extracted from the hip while lying on their back. Researchers will compare the results from both extraction sites on each patient, as well as compare results of the two patient position groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single site, comparative quantitative analysis study of the cellular characteristics of bone marrow aspirate from two extraction sites (PSIS and humerus) from patients undergoing standard-of-care arthroscopic rotator cuff repair surgery. 30 total patients will be recruited through the Andrews Institute physician practices. A recruitment flyer will be used to recruit participants. The flyer will be placed within physicians' offices and on social media platforms. Potential participants will be prescreened for inclusion and exclusion criteria through standard of care medical evaluations. Once a potential participant has agreed to be involved in the study, they will go through the described informed consent process. Patients meeting the inclusion criteria will have the study explained to them by one of the members of the research team, and they will be given an opportunity to participate if they are interested.

After the described screening and informed consent process have been completed, all participants will undergo standard-of-care arthroscopic rotator cuff repair surgery. During all surgeries, bone marrow will be aspirated from the PSIS and from the humerus. The first 15 participants will have bone marrow aspirated from the PSIS while in the prone position on the operating table. The final 15 participants will have bone marrow aspirated from the PSIS while in the lateral decubitus position on the operating table. Both cohorts will undergo humeral harvest intraoperatively in the lateral decubitus position. One mL of concentrated bone marrow aspirate (cBMA) from each harvest site from each surgery will be removed and sent to the AREF Regenerative Medicine Center (RMC) for analysis. The remaining cBMA will be used to augment the rotator cuff repair surgery.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The focus demographic of this study is people within the ages of 18 and 80 that have been diagnoses with a rotator cuff tear and require reconstructive surgery.

Description

Inclusion Criteria:

  • 18-80 years of age
  • Diagnosis of a rotator cuff tear requiring arthroscopic rotator cuff repair

Exclusion Criteria:

  • Patients who require superior capsular reconstruction or revision rotator cuff repair
  • Diabetes
  • Immune Disorders
  • Past medical history of a metastatic or other cancer which required chemotherapy/ radiation therapy
  • Rheumatoid arthritis
  • Is unable to comprehend the study documents or give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bone marrow harvest from side-lying patient
This group will have bone marrow harvested from the PSIS extraction site while lying in the lateral decubitus position.
Procedure: Rotator Cuff Repair
Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)
Procedure: Bone Marrow Harvest
Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body
Other Names:
  • Bone Marrow Aspiration
Bone marrow harvest from patient lying prone
This group will have bone marrow harvested from the PSIS extraction site while lying in the prone position.
Procedure: Rotator Cuff Repair
Surgical repair of one or more ligament(s) that form the rotator cuff shoulder complex (supraspinatus, infraspinatus, subscapularis, and teres minor)
Procedure: Bone Marrow Harvest
Procedure in which bone marrow cells are extracted, or harvested, from a given location in the body
Other Names:
  • Bone Marrow Aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemocytometer (Sysmex)
Time Frame: Upon day of surgical procedure (once per participant)
Machine that separates blood cells into categories, including red blood cell (RBC), white blood cell (WBC), monocyte, platelet, and hematopoietic progenitor cell (HPC) groups to assess concentration
Upon day of surgical procedure (once per participant)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrews Research & Education Foundation

Collaborators

Florida

Investigators

  • Principal Investigator: Joshua Hackel, MD, Orthopedic Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2022

Primary Completion (Anticipated)

August 16, 2023

Study Completion (Anticipated)

August 16, 2023

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 6, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC Comp (BioCuff)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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