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Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

Primary Purpose

Osteoarthritis Post-meniscectomy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Bone Marrow Aspirate Concentrate

Standard Meniscectomy

About this trial

This is an interventional prevention trial for Osteoarthritis Post-meniscectomy focused on measuring Mesenchymal stem cells, Bone marrow aspirate concentrate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)

Meniscectomy with Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

International Knee Documentation Committee (IKDC) Score

The primary outcome measure will be the IKDC score at one year follow-up

Secondary Outcome Measures

Patient reported outcomes throughout follow-up period

Patient reported outcomes will include change in scores from preoperative to Postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Synovial fluid analysis

To investigate any changes in synovial fluid markers of osteoarthritis.

Radiographic analysis

The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years.

Patient reported outcomes throughout follow-up period (VAS)

Visual Analog Score (VAS)

Patient reported outcomes throughout follow-up period (IKDC)

International Knee Documentation Committee form (IKDC)

Patient reported outcomes throughout follow-up period (KOOS)

Knee injury and Osteoarthritis Outcome Score (KOOS)

Patient reported outcomes throughout follow-up period (SF-12)

(Short Form Health Survey) SF-12

Full Information

NCT ID

NCT02582489

First Posted

October 19, 2015

Last Updated

March 13, 2023

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02582489

Brief Title

Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

Official Title

Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 22, 2017 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis Post-meniscectomy

Keywords

Mesenchymal stem cells, Bone marrow aspirate concentrate

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC)

Arm Type

Experimental

Arm Description

Arm Title

Meniscectomy with Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Bone Marrow Aspirate Concentrate

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard Meniscectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

International Knee Documentation Committee (IKDC) Score

Description

The primary outcome measure will be the IKDC score at one year follow-up

Time Frame

One Year

Secondary Outcome Measure Information:

Title

Patient reported outcomes throughout follow-up period

Description

Patient reported outcomes will include change in scores from preoperative to Postoperative Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame

7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

Title

Synovial fluid analysis

Description

To investigate any changes in synovial fluid markers of osteoarthritis.

Time Frame

2 weeks, 6 weeks

Title

Radiographic analysis

Description

The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years.

Time Frame

1 year, 2 years

Title

Patient reported outcomes throughout follow-up period (VAS)

Description

Visual Analog Score (VAS)

Time Frame

7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

Title

Patient reported outcomes throughout follow-up period (IKDC)

Description

International Knee Documentation Committee form (IKDC)

Time Frame

7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

Title

Patient reported outcomes throughout follow-up period (KOOS)

Description

Knee injury and Osteoarthritis Outcome Score (KOOS)

Time Frame

7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

Title

Patient reported outcomes throughout follow-up period (SF-12)

Description

(Short Form Health Survey) SF-12

Time Frame

7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carla Edwards, PhD

Phone

312-563-5735

carla_edwards@rush.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian J Cole, MD, MBA

Organizational Affiliation

Midwest Orthopaedics at Rush

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barb L Ramsey, RN

Phone

312-563-2883

First Name & Middle Initial & Last Name & Degree

Brian J Cole, MD, MBA

First Name & Middle Initial & Last Name & Degree

Nikhil N Verma, MD

First Name & Middle Initial & Last Name & Degree

Adam B Yanke, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20720135

Citation

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.

Results Reference

background

PubMed Identifier

26069587

Citation

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.

Results Reference

background

PubMed Identifier

25480381

Citation

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.

Results Reference

background

PubMed Identifier

24398701

Citation

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.

Results Reference

background

PubMed Identifier

25276781

Citation

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.

Results Reference

background

PubMed Identifier

24430407

Citation

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.

Results Reference

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Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy

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