Chondral Lesion of the Knee study: Bone Marrow Aspirate vs Saline
Official title Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
ClinicalTrials.gov ID: NCT06893302
What this study is testing
What is Bone Marrow Aspirate (BMA)?
An investigational biological treatment being studied as an addition to knee arthroscopy surgery for meniscal injuries and cartilage damage.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding bone marrow aspirate during knee arthroscopy improves pain and function. It compares the new treatment to a salt water injection.
- Who it's for
- You may be able to join if you need knee arthroscopy for a meniscus tear or cartilage damage and are between 18 and 65 years old.
- What's involved
- You will have knee arthroscopy surgery. If you are in the treatment group, a small amount of bone marrow will be taken from your hip and injected into your knee. You will fill out pain and function questionnaires at several times after surgery.
- Time commitment
- The study lasts 12 months. You will have surgery and then complete questionnaires at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.