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Completed

NCT Number: NCT03130335

Intra-articular Autologous Bone Marrow Aspirate Injection for Knee Osteoarthritis

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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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >=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

Exclusion criteria

  • 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

Treatment and study plan

BMA Injection

Procedure

Bone marrow will be aspirated from the iliac crest and injected into the knee.

BMA

Biological

Bone marrow will be aspirated from the iliac crest.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

Intra-articular Autologous Bone Marrow Aspirate Injection for the Treatment of Knee Osteoarthritis: a Pilot Study With Radiological Follow-up

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2017
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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