Chondral Lesion of the KneeBMANCT06893302
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
A study testing Bone Marrow Aspirate (BMA), Arthroscopic Debridement Surgery and Saline in people with Chondral Lesion of the Knee and Meniscal Injuries, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chondral Lesion of the Knee, Meniscal Injuries, Cartilage Defects of the Knee
- What is being tested?
- Bone Marrow Aspirate (BMA), Arthroscopic Debridement Surgery and Saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2026to Apr 2030
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Require a primary knee arthroscopy for a meniscal injury or focal chondral defect (knee debridement or meniscectomy)
- Have Kellgren-Lawrence grade 0 arthritis
- Have Outerbridge cartilage grade 2 or lower
- Ages 18-64
Who cannot join
- Have previously undergone ipsilateral knee surgery
- Have Kellegren-Lawrence grade 3 or greater
- Have received other OrthoBiologics within 3 mo of surgery
- Have ligament deficiencies
- Need meniscal repair
- Need a concomitant osteotomy or other realignment surgery
Show all 10Show fewer
- Have used DMARDs within the last three months
- Have a hx of anemia, bleeding disorders, or inflammatory joint disease (rheumatoid arthritis, infectious arthritis, hemophilic arthropathy, Charcot's knee)
- Have a hx of metabolic bone disease (osteoporosis, osteomalacia, rickets, osteitis fibrosa cystica, Paget's disease of bone)
- Patients who are currently pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial
This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Like flipping a coin, patients will be randomly assigned to one of two groups of 25 patients each. One group will receive standard arthroscopic surgery plus an injection of bone marrow aspirate, while the other group will receive standard surgery plus a saline (salt water) injection. During surgery, for patients in the treatment group, approximately 4mL (less than one teaspoon) of bone marrow will be taken from their hip bone using a special needle system. A small amount (1mL) will be sent to the laboratory for testing. Patients will be followed for 12 months after surgery and will complete questionnaires about their pain levels and knee function at several time points: before surgery, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. These questionnaires will ask about pain, daily activities, and overall improvement.
Read the detailed description
There is a paucity of high-quality literature surrounding the efficacy of BMA in knee arthroscopy, and this study will help to fill this gap. The investigators can obtain preliminary data that indicates the effect of BMA on patient reported outcomes and also help identify evaluation end points for future BMA randomized trials. Additionally, this study will allow us to see how CFU, CD140, and CBC counts compare between BMA and BMAC. Our study will not be evaluating BMAC, just comparing the BMA numbers to previously reported BMAC counts. Cervos' BMA product could offer improved patient reported outcomes from knee arthroscopy. If this is true, this study could expand the reach of Cervos' BMA, improving the field of knee arthroscopy surgery and helping push orthopedics forward. Additionally, it could save surgeons and lab technicians time, and hospital's money, by removing the centrifugation step required in bone marrow concentrate products. Alternatively, no effect could help save patients money and help surgeons avoid this unnecessary treatment.
A total of 50 patients with osteoarthritis of the knee will be randomly assigned to receive arthroscopic debridement surgery or arthroscopic debridement surgery supplemented with bone marrow aspirate (BMA). Approximately 4mL of BMA will be obtained from different areas of the ilium using the Marrow Cellution™ aspiration system (Ranfac Corp., Avon, MA) following the manufacturer's instructions (Ranfac Technique Guide) intraoperatively for the patients in the treatment group. 1 mL of this will be set aside and sent to the lab for CBC, CD140 and CFU counts for comparison with other bone marrow aspirate products. Patients were randomized in equal numbers into either the treatment or control group (25 in each group). Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 12-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. The following measures will be included: IKDC, VAS, WOMAC, MARX, and PGIC will be collected at time points of baseline, 2 weeks, 6 weeks, and 3 months, 6 months, and 12 months.
- Conditions
- Chondral Lesion of the Knee, Meniscal Injuries, Cartilage Defects of the Knee, Osteoarthritis (OA) of the Knee
- Being tested
- Bone Marrow Aspirate (BMA), Arthroscopic Debridement Surgery, Saline
- Keywords
- knee arthroscopy, meniscal injury, knee debridement, meniscectomy, osteoarthritis, cartilage defect, chondral lesion, bone marrow aspirate, BMA
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate (BMA)Biological
Bone marrow aspirate (BMA) is being investigated as an augmentation to arthroscopic debridement surgery of the knee to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
Arthroscopic Debridement SurgeryProcedure or surgery
Arthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis.
SalineOther
Patients in the control arm of the study will receive arthroscopic debridement surgery along with a saline injection. This will be compared to the experimental arm, in which patients will receive arthroscopic debridement surgery along with a bone marrow aspirate injection.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Debridement Surgery + Saline | Active comparator | Arthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study, therefore it serves as an Active Comparator to the experimental arm which is the same procedure but with the addition of bone marrow aspirate (BMA) injection. Receives: Procedure: Arthroscopic Debridement Surgery; Other: Saline |
| Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA) | Experimental | Arthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study. The study investigates the effect of combining the standard of care with a bone marrow aspirate (BMA), therefore this serves as the Active Experimental arm. Receives: Biological: Bone Marrow Aspirate (BMA); Procedure: Arthroscopic Debridement Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcomes Score (KOOS)
0-100 score range, with 0 representing extreme knee problems and 100 representing no knee problems.
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start3 Feb 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondral Lesion of the KneeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to receive arthroscopic debridement surgery with saline injection or arthroscopic debridement surgery supplemented with bone marrow aspirate (BMA) injection.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anil S Ranawat, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893302
- Sponsor's protocol ID
- 2023-2344
- Acronym
- BMA
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Aspirate Injections in Knee Arthroscopy: A Randomized, Single-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT06893302
- Acronym / sponsor ID
- BMA / 2023-2344
- Conditions
- Chondral Lesion of the Knee, Meniscal Injuries, Cartilage Defects of the Knee, Osteoarthritis (OA) of the Knee
- Keywords
- knee arthroscopy, meniscal injury, knee debridement, meniscectomy, osteoarthritis, cartilage defect, chondral lesion, bone marrow aspirate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 25 Mar 2025 (actual)
- 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.
This study will examine whether using bone marrow aspirate (BMA) during knee arthroscopy surgery can improve patient outcomes. The investigators will enroll 50 patients who need knee arthroscopy surgery for meniscus injuries or cartilage damage. Like flipping a coin, patients will be randomly assigned to one of two groups of 25 patients each. One group will receive standard arthroscopic surgery plus an injection of bone marrow aspirate, while the other group will receive standard surgery plus a saline (salt water) injection. During surgery, for patients in the treatment group, approximately 4mL (less than one teaspoon) of bone marrow will be taken from their hip bone using a special needle system. A small amount (1mL) will be sent to the laboratory for testing. Patients will be followed for 12 months after surgery and will complete questionnaires about their pain levels and knee function at several time points: before surgery, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery. These questionnaires will ask about pain, daily activities, and overall improvement.
Detailed description
There is a paucity of high-quality literature surrounding the efficacy of BMA in knee arthroscopy, and this study will help to fill this gap. The investigators can obtain preliminary data that indicates the effect of BMA on patient reported outcomes and also help identify evaluation end points for future BMA randomized trials. Additionally, this study will allow us to see how CFU, CD140, and CBC counts compare between BMA and BMAC. Our study will not be evaluating BMAC, just comparing the BMA numbers to previously reported BMAC counts. Cervos' BMA product could offer improved patient reported outcomes from knee arthroscopy. If this is true, this study could expand the reach of Cervos' BMA, improving the field of knee arthroscopy surgery and helping push orthopedics forward. Additionally, it could save surgeons and lab technicians time, and hospital's money, by removing the centrifugation step required in bone marrow concentrate products. Alternatively, no effect could help save patients money and help surgeons avoid this unnecessary treatment.
A total of 50 patients with osteoarthritis of the knee will be randomly assigned to receive arthroscopic debridement surgery or arthroscopic debridement surgery supplemented with bone marrow aspirate (BMA). Approximately 4mL of BMA will be obtained from different areas of the ilium using the Marrow Cellution™ aspiration system (Ranfac Corp., Avon, MA) following the manufacturer's instructions (Ranfac Technique Guide) intraoperatively for the patients in the treatment group. 1 mL of this will be set aside and sent to the lab for CBC, CD140 and CFU counts for comparison with other bone marrow aspirate products. Patients were randomized in equal numbers into either the treatment or control group (25 in each group). Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 12-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. The following measures will be included: IKDC, VAS, WOMAC, MARX, and PGIC will be collected at time points of baseline, 2 weeks, 6 weeks, and 3 months, 6 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to receive arthroscopic debridement surgery with saline injection or arthroscopic debridement surgery supplemented with bone marrow aspirate (BMA) injection.
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Debridement Surgery + Saline | Active comparator | Procedure: Arthroscopic Debridement Surgery, Other: SalineArthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study, therefore it serves as an Active Comparator to the experimental arm which is the same procedure but with the addition of bone marrow aspirate (BMA) injection. |
| Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA) | Experimental | Biological: Bone Marrow Aspirate (BMA), Procedure: Arthroscopic Debridement SurgeryArthroscopic debridement surgery is standard of care to treat the conditions that are within the inclusion criteria of the study. The study investigates the effect of combining the standard of care with a bone marrow aspirate (BMA), therefore this serves as the Active Experimental arm. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Require a primary knee arthroscopy for a meniscal injury or focal chondral defect (knee debridement or meniscectomy)
- Have Kellgren-Lawrence grade 0 arthritis
- Have Outerbridge cartilage grade 2 or lower
- Ages 18-64
Key exclusion criteria (10 listed)
- Have previously undergone ipsilateral knee surgery
- Have Kellegren-Lawrence grade 3 or greater
- Have received other OrthoBiologics within 3 mo of surgery
- Have ligament deficiencies
- Need meniscal repair
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 (BMA)Bone marrow aspirate (BMA) is being investigated as an augmentation to arthroscopic debridement surgery of the knee to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis. | Biological | Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA) |
| Arthroscopic Debridement SurgeryArthroscopic debridement surgery of the knee is performed to treat conditions such as meniscal injuries, chondral defects, and low-grade osteoarthritis. | Procedure or surgery | Arthroscopic Debridement Surgery + Bone Marrow Aspirate (BMA), Arthroscopic Debridement Surgery + Saline |
| SalinePatients in the control arm of the study will receive arthroscopic debridement surgery along with a saline injection. This will be compared to the experimental arm, in which patients will receive arthroscopic debridement surgery along with a bone marrow aspirate injection. | Other | Arthroscopic Debridement Surgery + Saline |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 month follow-up
Knee Injury and Osteoarthritis Outcomes Score (KOOS) 0-100 score range, with 0 representing extreme knee problems and 100 representing no knee problems.
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 2 Sep 2026.
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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.
Anil S Ranawat, MD principal investigator
Hospital for Special Surgery, New York
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 (BMA), Arthroscopic Debridement Surgery and Saline in people with Chondral Lesion of the Knee and Meniscal Injuries, run by Hospital for Special Surgery, New York 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Sep 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. 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?
Contact Akshay K Raghuram ((646) 714-6067, raghurama@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.