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Knee Injections for the Clinical Management of Knee OsteoArthritis

NCT04595890 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-02

No results posted yet for this study

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

Interventions

DEVICE

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

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).

OTHER

Saline injection

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).

Sponsors & Collaborators

  • University of Delaware

    lead OTHER

Principal Investigators

  • Daniel K White, PT, ScD, MSc · University of Delaware

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-09-01
Completion
2024-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595890 on ClinicalTrials.gov