Marrow Cellution™ vs. Traditional BMA Harvest Project

Trial Title: Marrow Cellution™ vs. Traditional BMA Harvest Project

NCT ID: NCT06388993

Condition: Hip Arthropathy
Avascular Necrosis of Bone
Subchondral Cysts

Conditions: Official terms:
Bone Cysts
Osteonecrosis
Necrosis

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Bone Marrow Collection
Description: Comparing the two collection systems for bone marrow aspirate
Arm group label: Bilateral Hip Bone Marrow Collection

Summary: Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research,

Detailed description: l

Criteria for eligibility:
Criteria:
Inclusion Criteria: - patients aged 18 - 50 - patients undergoing hip arthroscopy for subchondral bone cysts and/or avascular necrosis Exclusion Criteria: - patients with a history of hematologic issues including anemia and sickle cell anemia - patients with a history of leukemia, lymphoma, or other bone marrow related diseases - patients with diabetes - patients with a history of bone marrow aspirate

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: No

Locations:

Facility:
Name: Jameson Crane Sports Medicine Institute

Address:
City: Columbus
Zip: 43202
Country: United States

Status: Recruiting

Contact:
Last name: Michael Keller

Phone: 614-293-2410
Email: michael.keller@osumc.edu

Contact backup:
Last name: Karen Persons
Email: andrea.persons@osumc.edu

Investigator:
Last name: William K Vasileff, MD
Email: Principal Investigator

Start date: March 25, 2024

Completion date: March 31, 2025

Lead sponsor:
Agency: Ohio State University
Agency class: Other

Source: Ohio State University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06388993