Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03130335|
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : January 14, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: BMA Injection Biological: BMA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up|
|Actual Study Start Date :||April 28, 2017|
|Actual Primary Completion Date :||August 12, 2019|
|Actual Study Completion Date :||October 1, 2019|
|Experimental: Bone Marrow Aspirate (BMA) Injection||
Procedure: BMA Injection
Bone marrow will be aspirated from the iliac crest and injected into the knee.
Bone marrow will be aspirated from the iliac crest.
- Knee Injury and Osteoarthritis Outcome Score (KOOS) Jr. [ Time Frame: 1 month after date of injection ]The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
- KOOS Jr. [ Time Frame: 3 months after date of injection ]The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
- KOOS Jr. [ Time Frame: 6 months after date of injection ]The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
- KOOS Jr. [ Time Frame: 12 months after date of injection ]The KOOS Jr. measures patient-reported pain and function. The score ranges from 0-100, with 0 representing total knee disability and 100 representing perfect knee health.
- Pain [ Time Frame: 1 month, 3 months, 6 months, and 12 months after date of injection ]Pain will be assessed using the numerical rating scale (NRS), which is on a scale of 0-10. 10 represents worst pain, and 0 represents no pain.
- Degree of cartilage change [ Time Frame: 6 months (first 5 patients only) and 12 months after date of injection ]Cartilage change will be assessed via magnetic resonance imaging.
- Presence of side effects [ Time Frame: 1 month, 3 months, 6 months, and 12 months after date of injection ]The presence of side effects, including increased pain, bleeding, infection, and motor-sensory deficits, will be documented.
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|Ages Eligible for Study:||18 Years to 79 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- >=3 months of symptomatic knee OA unresponsive to at least two of the following: activity modification, physical therapy, bracing, assistive devices, acupuncture, non-steroidal anti-inflammatory medications, local steroid injections, and hyaluronic acid injections
- Radiographically confirmed Kellgren-Lawrence I-II knee OA (mild knee OA; no bone-on-bone)
- Age 18-79 years
- Presence of loose bodies on baseline magnetic resonance imaging
- Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiences
- History of meniscal injury other than degenerative meniscal tears
- Previous knee surgery
- Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way
- Intra-articular injection to affected knee within 6 weeks of intra-articular BMA injection
- Mechanical axis deviation greater than 7 degrees
- Intolerance to acetaminophen or hydrocodone (i.e., Vicodin)
- Use of non-steroidal anti-inflammatory drugs <1 weeks prior to BMA
- Injection of the joint scheduled for treatment within 3 months of BMA injection
- Body mass index of 30 or more
- History of drug abuse
- Current cigarette smokers
- Current use of systemic steroids
- History of or current alcohol abuse or dependence
- History of anemia, bleeding disorders, or inflammatory joint disease
- Active infection
- Active malignancy per medical or surgical history, diagnosed by primary case physician or treating specialist, undergoing treatment, has undergone treatment, or has declined treatment
- Inability to refrain from statin regimen from 1 month pre-injection to 1 month post-injection
- Pregnancy or breastfeeding at time of treatment
- Participating or planning to participate in a worker's compensation program at the time of treatment or follow-up period
- Pending or planned legal action pertaining to knee pain
- Non-English speaking
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130335
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Gregory Lutz||Hospital for Special Surgery, New York|
|Responsible Party:||Hospital for Special Surgery, New York|
|Other Study ID Numbers:||
|First Posted:||April 26, 2017 Key Record Dates|
|Last Update Posted:||January 14, 2020|
|Last Verified:||January 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|