Hospital for Special Surgery
New York, 10021, United States
NCT Number: NCT03130335
Knee osteoarthritis (OA) is a leading cause of disability. The objectives of treatment are to reduce pain, improve function, and slow down further breakdown of the knee. Recently, research on nonsurgical treatment options for knee OA has increased significantly. One potential treatment of interest is the use of stem cell injections. Stem cells are one's own cells that have the ability to divide into other types of cells, and may cause regrowth of cartilage when injected into the knee. There have been few, but promising, studies that show improvements in pain and function with stem cell injections in those with knee OA. Therefore, more research is needed to identify patients who might benefit from this injection. This pilot study will look at changes in pain and function for 20 patients at 1, 3, 6, and 12 months after a stem cell injection into the knee. Patients will also undergo magnetic resonance imaging at 6 months and 12 months following the injection.
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Notify Me18 year–79 year
All sexes
Interventional
Not applicable
New York, 10021, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bone marrow will be aspirated from the iliac crest and injected into the knee.
Bone marrow will be aspirated from the iliac crest.
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.
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.
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.
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.
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.
Time frame: 6 months (first 5 patients only) and 12 months after date of injection
Cartilage change will be assessed via magnetic resonance imaging.
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.
Hospital for Special Surgery, New York
Other
Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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