Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

NCT ID: NCT02582489

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-22
• Study Completion Date: 2026-12-31

Brief Summary

The proposed research study aims to evaluate the effects of autologous bone marrow aspirate concentrate (BMAC) on the development and progression of osteoarthritis (OA) in patients undergoing meniscectomy. This prospective, randomized, double-blind clinical trial will compare patient-reported outcomes, specifically IKDC scores between patients who receive BMAC post-meniscectomy and those who receive a saline control injection. The study will also compare physical examination, MRI, radiographs, and synovial fluid analysis. Our hypothesis is that those who receive the autologous BMAC injection after the procedure will have better outcomes than those who do not.

Detailed Description

Recent studies have demonstrated both the safety of BMAC intra-articular injection and improvements in subjective, patient reported outcomes in patients with existing knee OA. Unfortunately these studies were largely uncontrolled, underpowered, and/or retrospective in nature. Additionally, a recent prospective, randomized clinical study of allograft mesenchymal stem cells (MSCs) injected at a separate time point post surgical intervention has highlighted the ability of MSCs to increase meniscal volume and improve knee pain following injection.

This will be the first study to examine the effects of autograft BMAC intra-articular injection in a single-stage procedure and in a prospective, randomized, double-blind fashion. The results of this study, if the null hypothesis is rejected, will have far-reaching implications for the standard of care in meniscal treatment and on OA progression in the knee. Additionally, if the results of this study are favorable in reduction of OA progression this study will change the surgical approach to all axial, synovial joints including the shoulder, elbow, wrist, hip, and ankle.

Conditions

Osteoarthritis Post-meniscectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)

Subjects will undergo the scheduled meniscectomy procedure. Following the procedure the investigator will make a small incision and create the marrow access channel in the proximal tibia. The experimental group will then have bone marrow harvested and BMAC will be prepared using a BMAC harvesting system. The automated centrifuge system rapidly concentrates cellular contents and growth factors in bone marrow aspirate using flow cytometry. The BMAC will be injected intra-articularly.

Group Type: EXPERIMENTAL

Bone Marrow Aspirate Concentrate

Intervention Type: BIOLOGICAL

Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.

Standard Meniscectomy

Intervention Type: PROCEDURE

All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.

Meniscectomy with Placebo

Subjects will undergo the same meniscectomy procedure and will also have an incision and marrow access channel made in the proximal tibia, however no bone marrow will be harvested. The control group will have a placebo injection of saline into the affected knee.

Group Type: PLACEBO_COMPARATOR

Standard Meniscectomy

Intervention Type: PROCEDURE

All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.

Interventions

Bone Marrow Aspirate Concentrate

Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.

Intervention Type: BIOLOGICAL

Standard Meniscectomy

All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subject is greater than 18 years old
• Written informed consent is obtained
• Subject is determined to have a symptomatic meniscal tear requiring a meniscectomy
• Meniscal pathology is confirmed through MRI and arthroscopically
• Subject agrees to all follow-up evaluations
• Osteoarthritis Kellen-Lawrence grade 1-3 on flexion PA and extension AP views

Exclusion Criteria

• Any subject lacking decisional capability
• Unwillingness to participate in the necessary follow-up
• Subject is pregnant or may become pregnant
• History of diabetes mellitus
• History of rheumatoid arthritis or other autoimmune disorder
• History of solid organ or hematologic transplantation
• Diagnosis of a non-basal cell malignancy within the preceding 5 years
• Infection requiring antibiotic treatment within the preceding 3 months
• Osteoarthritis Kellen-Lawrence grade 4 on flexion posterior-anterior (PA) or extension anteroposterior (AP) views
• Prior surgery on the index meniscus
• Concomitant surgery such as ligament surgery or cartilage repair or restoration
• Infection
• Prior cortisone/viscosupplementation/ (platelet rich plasma) PRP injection within 6 weeks

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian J Cole, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Midwest Orthopaedics at Rush

Locations

Rush University Medical Center

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carla Edwards, PhD

Role: CONTACT

carla_edwards@rush.edu

312-563-5735

Facility Contacts

Barb L Ramsey, RN

Role: primary

312-563-2883

References

Fortier LA, Potter HG, Rickey EJ, Schnabel LV, Foo LF, Chong LR, Stokol T, Cheetham J, Nixon AJ. Concentrated bone marrow aspirate improves full-thickness cartilage repair compared with microfracture in the equine model. J Bone Joint Surg Am. 2010 Aug 18;92(10):1927-37. doi: 10.2106/JBJS.I.01284.

Reference Type: BACKGROUND

PMID: 20720135 (View on PubMed)

Gobbi A, Karnatzikos G, Scotti C, Mahajan V, Mazzucco L, Grigolo B. One-Step Cartilage Repair with Bone Marrow Aspirate Concentrated Cells and Collagen Matrix in Full-Thickness Knee Cartilage Lesions: Results at 2-Year Follow-up. Cartilage. 2011 Jul;2(3):286-99. doi: 10.1177/1947603510392023.

Reference Type: BACKGROUND

PMID: 26069587 (View on PubMed)

Enea D, Cecconi S, Calcagno S, Busilacchi A, Manzotti S, Gigante A. One-step cartilage repair in the knee: collagen-covered microfracture and autologous bone marrow concentrate. A pilot study. Knee. 2015 Jan;22(1):30-5. doi: 10.1016/j.knee.2014.10.003. Epub 2014 Nov 20.

Reference Type: BACKGROUND

PMID: 25480381 (View on PubMed)

Kim JD, Lee GW, Jung GH, Kim CK, Kim T, Park JH, Cha SS, You YB. Clinical outcome of autologous bone marrow aspirates concentrate (BMAC) injection in degenerative arthritis of the knee. Eur J Orthop Surg Traumatol. 2014 Dec;24(8):1505-11. doi: 10.1007/s00590-013-1393-9. Epub 2014 Jan 8.

Reference Type: BACKGROUND

PMID: 24398701 (View on PubMed)

Centeno C, Pitts J, Al-Sayegh H, Freeman M. Efficacy of autologous bone marrow concentrate for knee osteoarthritis with and without adipose graft. Biomed Res Int. 2014;2014:370621. doi: 10.1155/2014/370621. Epub 2014 Sep 7.

Reference Type: BACKGROUND

PMID: 25276781 (View on PubMed)

Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058.

Reference Type: BACKGROUND

PMID: 24430407 (View on PubMed)

Yanke AB, Yazdi AA, Weissman AC, Wagner KR, Meeker ZD, Condron NB, Darwish RY, Drager J, Danilkowicz RM, Forsythe B, Verma NN, Cole BJ. A Prospective, Randomized, Double-Blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate During Arthroscopic Meniscectomy in Patients With Early Knee Osteoarthritis. Am J Sports Med. 2024 Oct;52(12):2963-2971. doi: 10.1177/03635465241275647. Epub 2024 Sep 15.

Reference Type: DERIVED

PMID: 39279266 (View on PubMed)

Other Identifiers

15090903

Identifier Type: -

Identifier Source: org_study_id