Clinical trial NCT04595890: Knee Injections for the Clinical Management of Knee OsteoArthritis
Official title: Knee Injections for the Clinical Management of Knee OsteoArthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Physical Activity
MRI
Autologous Nucleated Cells
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) is an incurable disease that involves breakdown of the knee joint. This breakdown is often accompanied by knee pain and stiffness, which can limit a person's daily physical activity. Fortunately, there are treatments that may stop or slow the progression of knee OA. Bone marrow aspirate can be extracted and processed into autologous, nucleated cells, then injected back into the knee affected by OA. These cells provide important nutrients that can improve the health of the knee joint and alleviate the symptoms of knee OA.

Therefore, the investigators are interested in determining whether an injection of autologous, nucleated cells can improve physical activity, pain and function in people who are diagnosed with knee OA.

The investigators will recruit a total of 100 subjects for this study and examine changes in physical activity using a research-grade Actigraph Monitor.


Eligibility criteria: Inclusion Criteria:

* Adults 40-79 years of age
* Doctor-diagnosed knee OA

Exclusion Criteria:

Related to knee OA diagnosis:

* Seeking treatment for end-stage knee OA (Kellgren-Lawrence Grade 4 on X-ray)
* Seeking advanced treatment options for knee OA (e.g., knee replacement) within 6 months
* Seeking treatment for bilateral symptomatic knee OA

Related to current health status or medical history:

* Findings on clinical examination that preclude safe participation in the study, including (but not limited to):

  * 3+ effusion of the target knee
  * Significant varus or valgus alignment deformity
* Non-ambulatory (e.g., use a manual or power wheelchair)
* Diagnosis of rheumatoid arthritis, inflammatory arthritis, or gout
* Uncontrolled diabetes (e.g., glycosylated hemoglobin level \>7.0)
* Known contraindications to MRI, including: heart pacemaker, artificial heart valves, metal implants such as metal ear implants, bullet pieces, chemotherapy or insulin pumps, metal clips or rings
* Body mass index \> 40 kg/m 2
* Increased risk for postsurgical bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin)
* Increased risk for postsurgical infection (e.g., taking immunosuppressants, having a severe infection, or a having a history of serious infection)
* Known allergy to lidocaine or other anesthetics
* History of anemia
* Recent infection of target knee (within last month) requiring antibiotics
* History of bone marrow harvest or biopsy at any time
* Active malignancy or history of bone marrow malignancy

Related to previous OA management:

* Previous corticosteroid injection in the target knee within the last 3 months
* Previous viscosupplementation injection in the target knee within the last 6 months
* Previous PRP or stem cell injection in the target knee
* Previous surgery in the target knee within the last 12 months
* Previous partial or total knee replacement of the target knee
* Recent or planned surgery in the lower extremity of the target knee within 6 months

Related to other personal factors:

* Impaired cognition that impacts the ability to give informed consent
* Intense fear of needles
* Intense fear of small, enclosed spaces (i.e., claustrophobia)
* Unable to remain still for duration of MRI procedure without a sedative or anesthetic
* Likely unable to attend follow-up study visits over 6 months while enrolled in the study

Primary outcomes:
measure: Physical Activity
timeFrame: Change in physical activity from baseline to 3 months.
Secondary outcomes:
measure: Pain of Target Knee
timeFrame: Change in pain of target knee from baseline to 3 weeks, and change in pain of target knee from baseline to 3 months.
measure: Function of Target Knee
timeFrame: Change in function of target knee from baseline to 3 weeks, and change in function of target knee from baseline to 3 months.
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Daniel K White, PT, ScD, MSc
role: PRINCIPAL_INVESTIGATOR
References: