Knee Injections for the Clinical Management of Knee OsteoArthritis

NCT04595890 | Withdrawn DMC FDA Device

• 1 other identifier: 1893057
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Physical Activity; MRI; Autologous Nucleated Cells

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  The investigators will use the Actigraph GT3X (Actigraph LLC, Pensacola, FL) to objectively measure physical activity. The Actigraph GT3X is a hip-worn accelerometer that measures the intensity of physical activity on a minute-by-minute basis. The Actigraph GT3X is valid and reliable in community-dwelling older adults with knee OA.

  Change in physical activity from baseline to 3 months.

Secondary Outcomes (2)

• Pain of Target Knee

  Change in pain of target knee from baseline to 3 weeks, and change in pain of target knee from baseline to 3 months.

• Function of Target Knee

  Change in function of target knee from baseline to 3 weeks, and change in function of target knee from baseline to 3 months.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Injection of Bone Marrow Concentrate (BMC)

Device: Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC)

Control Group

PLACEBO COMPARATOR

Injection of saline

Other: Saline injection

Interventions

Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC) DEVICE

Participants will have bone marrow aspirated from their iliac crest, then processed using the Arthrex Angel System to produce autologous bone marrow concentrate (BMC). Then, BMC will be injected into the participant's knee with knee osteoarthritis (OA).

Intervention Group

Saline injection OTHER

Participants will have bone marrow aspirated from their iliac crest to maintain masking. Then, saline will be injected into the participant's knee with knee osteoarthritis (OA).

Control Group

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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):
• + 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)

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daniel K White, PT, ScD, MSc

  University of Delaware

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)