Clinical trial NCT02582489: 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
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Post-meniscectomy
Keywords: Mesenchymal stem cells
Bone marrow aspirate concentrate
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Score
timeFrame: One Year
Secondary outcomes:
measure: Patient reported outcomes throughout follow-up period
timeFrame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Synovial fluid analysis
timeFrame: 2 weeks, 6 weeks
measure: Radiographic analysis
timeFrame: 1 year, 2 years
measure: Patient reported outcomes throughout follow-up period (VAS)
timeFrame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Patient reported outcomes throughout follow-up period (IKDC)
timeFrame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Patient reported outcomes throughout follow-up period (KOOS)
timeFrame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
measure: Patient reported outcomes throughout follow-up period (SF-12)
timeFrame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Midwest Orthopaedics at Rush
name: Brian J Cole, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.