OsteoarthritisNCT02713542
Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
A study testing ACP in people with Osteoarthritis, run by Arthrex, Inc. at 4 sites in United States.
Trial summary
This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ACP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2016to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is 18 to 70 years of age.
- The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
- The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
- The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities
Who cannot join
- Grade I and IV on the knee Kellgren-Lawrence grading scale
- Subject has clinically 3+ effusion of the target knee (stroke test grading system).
- Subject has significant (> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
- Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
- Viscosupplementation in any joint in the past six months.
- Subject has an increased risk for post- procedure bleeding (e.g., bleeding disorder or taking anticoagulants except low-dose aspirin).
Show all 16Show fewer
- Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months
- Subject has inflammatory disease of either knee other than OA.
- Subject with underlying medical conditions that could interfere with the evaluation of the outcome.
- Subject with positive pregnancy test, or breast feeding.
- Subject with plans to participate in other clinical trial involving medical or surgical intervention in the next 12 months.
- Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- Subject has rheumatoid arthritis or gout
- Subject has a history of or a current infection at the affected joint.
- Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
- Subject requires pain management therapy (with the exception of acetaminophen) not related to the target knee.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
MedSport University of Michigan Sports Medicine
Ann Arbor, Michigan, 48106
Rush University Medical Center
Chicago, Illinois, 60612
Columbia Orthopedic Group
Columbia, Missouri, 65201
Hawkins Foundation
Greenville, South Carolina, 29615
About this study
This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.
Read the detailed description
This study is a prospective, multi center randomized double blind, two arm study.
90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.
- Conditions
- Osteoarthritis
- Being tested
- ACP, Placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACPDevice
Autologous Conditioned Plasma
PlaceboOther
Also called Normal Saline
Three Normal Saline IA injections of 3-8 mL at 1-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Conditioned Plasma (ACP) | Experimental | 3 Intra-articular (IA) injections at 1 week intervals Receives: Device: ACP |
| Normal Saline (NS) | Placebo comparator | 3 NS Intra-articular (IA) injections at 1 week intervals Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey
The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.
Measured: 6 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJul 2016
- Primary completion2 Jul 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Smith, MD, Principal investigator, Columbias Orthopedic Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713542
- Sponsor's protocol ID
- 004
- Status last verified
- Jul 2019
- First submitted
- 4 Feb 2016
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
- ClinicalTrials.gov ID
- NCT02713542
- Acronym / sponsor ID
- 004
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Posted 13 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is primarily investigating the effectiveness of Autologous Conditioned Plasma (ACP) Intra-articular (IA) in patients with Osteoarthritis (OA) in the knee.
Detailed description
This study is a prospective, multi center randomized double blind, two arm study.
90 subjects will be randomized to receive injections of either Autologous Conditioned Plasma Intra-articular or the control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Conditioned Plasma (ACP) | Experimental | Device: ACP3 Intra-articular (IA) injections at 1 week intervals |
| Normal Saline (NS) | Placebo comparator | Other: Placebo3 NS Intra-articular (IA) injections at 1 week intervals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject is 18 to 70 years of age.
- The subject presents with complaints of continued pain of primary knee for at least 6 weeks.
- The subject has documented radiographs evidence of Osteoarthritis (OA) in the tibio-femoral or patella-femoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 24 weeks of screening.
- The subject has a WOMAC pain score of at least 8 out of 20 and at least moderate pain (a score of 2) for at least 2 questions on activities
Key exclusion criteria (16 listed)
- Grade I and IV on the knee Kellgren-Lawrence grading scale
- Subject has clinically 3+ effusion of the target knee (stroke test grading system).
- Subject has significant (> 10⁰) valgus or varus deformities as evidenced by standard of care X-ray.
- Subject has had systemic or IA injection of corticosteroids in any joint within three months prior to screening.
- Viscosupplementation in any joint in the past six months.
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 |
|---|---|---|
| ACPAutologous Conditioned Plasma | Device | Autologous Conditioned Plasma (ACP) |
| PlaceboAlso: Normal SalineThree Normal Saline IA injections of 3-8 mL at 1-week intervals. | Other | Normal Saline (NS) |
Primary outcome
Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey
Time frame: 6 month visit
The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Patrick Smith, MD principal investigator
Columbias Orthopedic Group
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP in people with Osteoarthritis, run by Arthrex, Inc. at 4 sites 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 4 inclusion and 16 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey (time frame: 6 month visit). 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 13 Aug 2019.