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Could a simple blood injection ease knee arthritis pain?
NCT ID NCT05765266
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a single injection of platelet-rich plasma (PRP) from the ACP Max™ system can help people with knee osteoarthritis. Forty-five adults with knee pain and X-ray evidence of arthritis received either the PRP injection or a standard steroid injection. The main goal was to check safety and compare pain, stiffness, and function over 6 to 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Platelet-rich plasma (PRP) from the ACP Max™ system
- What this could lead to
- If it works, this could offer a longer-lasting, safer option for knee osteoarthritis pain relief compared to steroid injections.
- What could go wrong
- This is a small feasibility trial with only 45 participants, so results may not apply widely. The PRP injection may not outperform the steroid or could cause side effects like pain or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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45 people
The number who actually took part.
- Started
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May 2024
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject voluntarily decides to participate and signs the consent form. 2. Subject is ≥ 18 to 75 years of age. 3. 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. 4. 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. 5. 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. 6. 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). 7. Subject has a Body Mass Index ≤ 35 kg/m2 Exclusion Criteria: 1. Subject has Grade I or IV in the target knee according to the Kellgren-Lawrence grading scale. 2. Subject has clinically 3+ effusion of the target knee (stroke test grading system). 3. Subject has significant (\> 10°) valgus or varus deformities as evidenced by standard of care x-ray. 4. Subject has received an IA injection of corticosteroids in the target knee within 4 months prior to screening. 5. Subject did not achieve initial pain relief from prior corticosteroid injections. 6. Subject has received an IA injection of HA in the target knee within 6 months prior to screening. 7. Subject has received an IA injection of PRP in the target knee at any time prior to screening. 8. Subject has a history of coagulopathy. 9. 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. 10. Subject had prior open surgery on the target knee within 12 months or knee arthroscopy within 6 months. 11. Subject has an inflammatory disease of either knee other than OA. 12. Subject which, in the investigator's opinion, has an underlying medical condition(s) that could interfere with the evaluation of the outcome. 13. Subject with a positive pregnancy test or breastfeeding. 14. Subject plans to participate in other clinical trials involving medical or surgical intervention in the next 12 months. 15. Subject with any condition (including cognitive impairment) that, in the investigator's opinion, might interfere with the evaluation of the study objectives. 16. Subject has rheumatoid arthritis or gout. 17. Subject has an infection at the affected joint. 18. Subject has a history of major trauma to the target knee within one year. 19. Subject with plans to undergo any elective orthopedic surgery in the next 12 months. 20. Subject requires pain management therapy not related to the target knee (with the exception of acetaminophen). 21. Subject has a known hypersensitivity to Depo-Medrol and its constituents.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AMR Knoxville
Knoxville, Tennessee, 37920, United States
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Spectrum Medical, Inc.
Danville, Virginia, 24541, United States
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The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
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