Knee OsteoarthritisKICK-OANCT04595890
Knee Injections for the Clinical Management of Knee OsteoArthritis
A study testing Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC) and Saline injection in people with Knee Osteoarthritis, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC) and Saline injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 40-79 years of age
- Doctor-diagnosed knee OA
Who cannot join
- 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):
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC), Saline injection
- Keywords
- Physical Activity, MRI, Autologous Nucleated Cells
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Saline injectionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Injection of Bone Marrow Concentrate (BMC) Receives: Device: Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC) |
| Control Group | Placebo comparator | Injection of saline Receives: Other: Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in physical activity from baseline to 3 months.
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Change in function of target knee from baseline to 3 weeks, and change in function of target knee from baseline to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Why it stopped: Discontinued funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel K White, PT, ScD, MSc, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595890
- Sponsor's protocol ID
- 1893057
- Acronym
- KICK-OA
- Status last verified
- Sep 2023
- First submitted
- 8 Oct 2020
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Injections for the Clinical Management of Knee OsteoArthritis
- ClinicalTrials.gov ID
- NCT04595890
- Acronym / sponsor ID
- KICK-OA / 1893057
- Conditions
- Knee Osteoarthritis
- Keywords
- Physical Activity, MRI, Autologous Nucleated Cells
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Discontinued funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC)Injection of Bone Marrow Concentrate (BMC) |
| Control Group | Placebo comparator | Other: Saline injectionInjection of saline |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 40-79 years of age
- Doctor-diagnosed knee OA
Key exclusion criteria (33 listed)
- 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
- Findings on clinical examination that preclude safe participation in the study, including (but not limited to):
- Non-ambulatory (e.g., use a manual or power wheelchair)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Intervention Group |
| Saline injectionParticipants 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). | Other | Control Group |
Primary outcome
Physical Activity
Time frame: Change in physical activity from baseline to 3 months.
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.
2 secondary outcomes
Pain of Target Knee
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.
Function of Target Knee
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel K White, PT, ScD, MSc principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrex Angel System used to prepare injection of Bone Marrow Concentrate (BMC) and Saline injection in people with Knee Osteoarthritis, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Change in physical activity from baseline to 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.