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Knee Injections for the Clinical Management of Knee OsteoArthritis (KICK-OA)

Primary Purpose

Knee Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC)
Saline injection
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Physical Activity, MRI, Autologous Nucleated Cells

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Injection of Bone Marrow Concentrate (BMC)

Injection of saline

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain of Target Knee
The investigators will ask participants to complete the Visual Analog Scale (VAS), a single-item instrument in which the participant makes a mark on a 100 mm line to indicate their pain score in each knee from 0-100. A higher score indicates greater pain intensity of the target knee. The instrument takes <1 minute to complete.
Function of Target Knee
The investigators will ask participants to complete the Knee Injury and Osteoarthritis Outcome Score (KOOS), a 42-item instrument that assesses the following five domains: pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The score is a percentage score from 0 to 100, 0 representing extreme problems of the target knee and 100 representing no problems of the target knee. The instrument takes approximately 10 minutes to complete.

Full Information

First Posted
October 8, 2020
Last Updated
September 28, 2023
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT04595890
Brief Title
Knee Injections for the Clinical Management of Knee OsteoArthritis
Acronym
KICK-OA
Official Title
Knee Injections for the Clinical Management of Knee OsteoArthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Discontinued funding
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Physical Activity, MRI, Autologous Nucleated Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Injection of Bone Marrow Concentrate (BMC)
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Injection of saline
Intervention Type
Device
Intervention Name(s)
Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC)
Intervention Description
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 Type
Other
Intervention Name(s)
Saline injection
Intervention Description
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).
Primary Outcome Measure Information:
Title
Physical Activity
Description
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.
Time Frame
Change in physical activity from baseline to 3 months.
Secondary Outcome Measure Information:
Title
Pain of Target Knee
Description
The investigators will ask participants to complete the Visual Analog Scale (VAS), a single-item instrument in which the participant makes a mark on a 100 mm line to indicate their pain score in each knee from 0-100. A higher score indicates greater pain intensity of the target knee. The instrument takes <1 minute to complete.
Time Frame
Change in pain of target knee from baseline to 3 weeks, and change in pain of target knee from baseline to 3 months.
Title
Function of Target Knee
Description
The investigators will ask participants to complete the Knee Injury and Osteoarthritis Outcome Score (KOOS), a 42-item instrument that assesses the following five domains: pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The score is a percentage score from 0 to 100, 0 representing extreme problems of the target knee and 100 representing no problems of the target knee. The instrument takes approximately 10 minutes to complete.
Time Frame
Change in function of target knee from baseline to 3 weeks, and change in function of target knee from baseline to 3 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel K White, PT, ScD, MSc
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Knee Injections for the Clinical Management of Knee OsteoArthritis

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