Knee OsteoarthritisNCT05765266
ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial
A study testing ACP Max™ and Depo-Medrol® in people with Knee Osteoarthritis, run by Arthrex, Inc. at 3 sites in United States.
Trial summary
This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ACP Max™ and Depo-Medrol®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 May 2024to 9 Feb 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject voluntarily decides to participate and signs the consent form.
- Subject is ≥ 18 to 75 years of age.
- Subject presents with symptomatic knee OA despite at least 6 months of one of the following conservative treatments; oral medications, analgesics, and/or anti-inflammatory medications.
- Subject has documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 12 weeks of screening.
- Subject has a WOMAC pain score (WOMAC A) of at least 8 out of 20 and at least moderate degree of difficulty (a score of 2) for at least 2 questions on performing daily activities.
- Subject consents to a washout period of NSAIDs and analgesics 7 days before each study visit (except low-dose aspirin for prevention of cardiovascular disease).
- Subject has a Body Mass Index ≤ 35 kg/m2
Who cannot join
- Subject has Grade I or IV in the target knee according to the Kellgren-Lawrence grading scale.
- Subject has clinically 3+ effusion of the target knee (stroke test grading system).
- Subject has significant (> 10°) valgus or varus deformities as evidenced by standard of care x-ray.
- Subject has received an IA injection of corticosteroids in the target knee within 4 months prior to screening.
- Subject did not achieve initial pain relief from prior corticosteroid injections.
- Subject has received an IA injection of HA in the target knee within 6 months prior to screening.
Show all 21Show fewer
- Subject has received an IA injection of PRP in the target knee at any time prior to screening.
- Subject has a history of coagulopathy.
- Subject has joint pain reflected by a VAS score of > 35 mm out of 100 mm scale in the contralateral knee at the time of screening.
- Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months.
- Subject has an inflammatory disease of either knee other than OA.
- Subject which, in the investigator's opinion, has an underlying medical condition(s) that could interfere with the evaluation of the outcome.
- Subject with a positive pregnancy test or breastfeeding.
- Subject plans to participate in other clinical trials involving medical or surgical intervention in the next 12 months.
- Subject with any condition (including cognitive impairment) that, in the investigator's opinion, might interfere with the evaluation of the study objectives.
- Subject has rheumatoid arthritis or gout.
- Subject has an infection at the affected joint.
- Subject has a history of major trauma to the target knee within one year.
- Subject with plans to undergo any elective orthopedic surgery in the next 12 months.
- Subject requires pain management therapy not related to the target knee (with the exception of acetaminophen).
- Subject has a known hypersensitivity to Depo-Medrol and its constituents.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Spectrum Medical, Inc.
Danville, Virginia, 24541
AMR Knoxville
Knoxville, Tennessee, 37920
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15).
Read the detailed description
All subjects will have a screening visit and a treatment visit followed by six follow-up visits: 10 days, 6 weeks, 3 months, 6 months, 9 months, and 12 months.
- Conditions
- Knee Osteoarthritis
- Being tested
- ACP Max™, Depo-Medrol®
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP Max™Device
Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™
Depo-Medrol®Device
Also called methylprednisolone acetate)
Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml.
| Study group | Role | What they receive |
|---|---|---|
| ACP Max™ | Experimental | Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™ Receives: Device: ACP Max™ |
| 40 mg of methylprednisolone acetate | Active comparator | Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml. Receives: Device: Depo-Medrol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
A comparison of the frequency and severity of all adverse events between the investigational group and the control group at 6 months.
Measured: 6 months
Adverse Events
Analysis of the frequency and severity of all adverse events for the investigational group at 12 months.
Measured: 12 months
Secondary outcomes (2)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert Scale
A 24-item questionnaire with 3 subscales measuring pain, stiffness, function and total scores.
Measured: Day 10, 6 weeks, 3, 6, 9 and 12 Months
Medication Usage
Medication Usage related to knee pain.
Measured: Day 10, 6 weeks, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start13 May 2024
- Primary completion15 Jul 2025
- Study completion9 Feb 2026
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765266
- Sponsor's protocol ID
- AIRR-0032
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2023
- Last updated
- 18 Feb 2026
- 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACP Max™ PRP System for Knee Osteoarthritis: A Feasibility Trial
- ClinicalTrials.gov ID
- NCT05765266
- Acronym / sponsor ID
- AIRR-0032
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 13 Mar 2023 (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.
This study is a prospective, multicenter (up to 4 sites), randomized, double-blind, two-arm study. Forty-five (45) patients will be randomized to receive a single 4-6 ml intra-articular (IA) injection of either the output of ACP Max™ (n=30) or 6 ml of Depo-Medrol® (methylprednisolone acetate) (n=15).
Detailed description
All subjects will have a screening visit and a treatment visit followed by six follow-up visits: 10 days, 6 weeks, 3 months, 6 months, 9 months, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACP Max™ | Experimental | Device: ACP Max™Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™ |
| 40 mg of methylprednisolone acetate | Active comparator | Device: Depo-Medrol®Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject voluntarily decides to participate and signs the consent form.
- Subject is ≥ 18 to 75 years of age.
- Subject presents with symptomatic knee OA despite at least 6 months of one of the following conservative treatments; oral medications, analgesics, and/or anti-inflammatory medications.
- Subject has documented radiographic evidence of OA in the tibiofemoral or patellofemoral compartment of the target knee (Kellgren-Lawrence Grades II-III), using radiographs performed within 12 weeks of screening.
- Subject has a WOMAC pain score (WOMAC A) of at least 8 out of 20 and at least moderate degree of difficulty (a score of 2) for at least 2 questions on performing daily activities.
Key exclusion criteria (21 listed)
- Subject has Grade I or IV in the target knee according to the Kellgren-Lawrence grading scale.
- Subject has clinically 3+ effusion of the target knee (stroke test grading system).
- Subject has significant (> 10°) valgus or varus deformities as evidenced by standard of care x-ray.
- Subject has received an IA injection of corticosteroids in the target knee within 4 months prior to screening.
- Subject did not achieve initial pain relief from prior corticosteroid injections.
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 |
|---|---|---|
| ACP Max™Single 4-6 ml intra-articular (IA) injection of the output of ACP Max™ | Device | ACP Max™ |
| Depo-Medrol®Also: methylprednisolone acetate)Single IA injection of 40 mg of methylprednisolone acetate (1 ml of solution) mixed with 5 ml of Normal Saline for a total of 6 ml. | Device | 40 mg of methylprednisolone acetate |
Primary outcome
Adverse Events
Time frame: 6 months
A comparison of the frequency and severity of all adverse events between the investigational group and the control group at 6 months.
Adverse Events
Time frame: 12 months
Analysis of the frequency and severity of all adverse events for the investigational group at 12 months.
2 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert Scale
Time frame: Day 10, 6 weeks, 3, 6, 9 and 12 Months
Medication Usage
Time frame: Day 10, 6 weeks, 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACP Max™ and Depo-Medrol® in people with Knee Osteoarthritis, run by Arthrex, Inc. at 3 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 7 inclusion and 21 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 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (time frame: 6 months). The study lists 2 primary outcomes in all. 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 18 Feb 2026.