Osteoarthritis Post-meniscectomyNCT02582489
Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
A study testing Bone Marrow Aspirate Concentrate and Standard Meniscectomy in people with Osteoarthritis Post-meniscectomy, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Post-meniscectomy
- What is being tested?
- Bone Marrow Aspirate Concentrate and Standard Meniscectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2017to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
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.
Read the 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
- Being tested
- Bone Marrow Aspirate Concentrate, Standard Meniscectomy
- Keywords
- Mesenchymal stem cells, Bone marrow aspirate concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate ConcentrateBiological
Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.
Standard MeniscectomyProcedure or surgery
All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.
| Study group | Role | What they receive |
|---|---|---|
| Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC) | Experimental | 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. Receives: Biological: Bone Marrow Aspirate Concentrate; Procedure: Standard Meniscectomy |
| Meniscectomy with Placebo | Placebo comparator | 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. Receives: Procedure: Standard Meniscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC) Score
The primary outcome measure will be the IKDC score at one year follow-up
Measured: One Year
Secondary outcomes (7)
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)
Measured: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Synovial fluid analysis
To investigate any changes in synovial fluid markers of osteoarthritis.
Measured: 2 weeks, 6 weeks
Radiographic analysis
The degree of OA will be examined in all patients preoperatively and at subsequent follow-up visits at 1 and 2 years.
Measured: 1 year, 2 years
Patient reported outcomes throughout follow-up period (VAS)
Visual Analog Score (VAS)
Measured: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (IKDC)
International Knee Documentation Committee form (IKDC)
Measured: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (KOOS)
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (SF-12)
(Short Form Health Survey) SF-12
Measured: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start22 Dec 2017
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Post-meniscectomyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian J Cole, MD, MBA, Principal investigator, Midwest Orthopaedics at Rush
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582489
- Sponsor's protocol ID
- 15090903
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2015
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 20720135Gobbi 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.
PubMed 26069587Enea 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.
PubMed 25480381Kim 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.
PubMed 24398701Centeno 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.
PubMed 25276781Vangsness 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.
PubMed 24430407Yanke 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.
PubMed 39279266
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind Clinical Trial to Investigate the Efficacy of Autologous Bone Marrow Aspirate Concentrate Post-Meniscectomy
- ClinicalTrials.gov ID
- NCT02582489
- Acronym / sponsor ID
- 15090903
- Conditions
- Osteoarthritis Post-meniscectomy
- Keywords
- Mesenchymal stem cells, Bone marrow aspirate concentrate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC) | Experimental | Biological: Bone Marrow Aspirate Concentrate, Procedure: Standard MeniscectomySubjects 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. |
| Meniscectomy with Placebo | Placebo comparator | Procedure: Standard MeniscectomySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Aspirate ConcentrateSubjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee. | Biological | Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC) |
| Standard MeniscectomyAll subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus. | Procedure or surgery | Meniscectomy with Bone Marrow Aspirate Concentrate (BMAC), Meniscectomy with Placebo |
Primary outcome
International Knee Documentation Committee (IKDC) Score
Time frame: One Year
The primary outcome measure will be the IKDC score at one year follow-up
7 secondary outcomes
Patient reported outcomes throughout follow-up period
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Synovial fluid analysis
Time frame: 2 weeks, 6 weeks
Radiographic analysis
Time frame: 1 year, 2 years
Patient reported outcomes throughout follow-up period (VAS)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (IKDC)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (KOOS)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Patient reported outcomes throughout follow-up period (SF-12)
Time frame: 7-10 days, 6 weeks, 3 months, 6 months, 1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 20720135Fortier 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.
- Background: PubMed 26069587Gobbi 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.
- Background: PubMed 25480381Enea 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.
- Background: PubMed 24398701Kim 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.
- Background: PubMed 25276781Centeno 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.
- Background: PubMed 24430407Vangsness 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.
- Derived from this study: PubMed 39279266Yanke 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J Cole, MD, MBA principal investigator
Midwest Orthopaedics at Rush
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Aspirate Concentrate and Standard Meniscectomy in people with Osteoarthritis Post-meniscectomy, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) Score (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02582489, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.