Posttraumatic OsteoarthritisNCT07142369
Synovial Fluid Withdrawal or PRP Injection For Acute ACL Tears and Cytokines
A study testing Synovial Fluid withdrawal at the preoperative clinic visit, Platelet-Rich Plasma (PRP) preparation and injection and Synovial fluid withdrawal at the time of surgery in people with Posttraumatic Osteoarthritis and Anterior Cruciate Ligament (ACL) Rupture, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine what effects the withdrawal of excess knee joint fluid or the injection of a factor from the blood has on swelling after a sudden anterior cruciate ligament (ACL) rupture of the knee. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Posttraumatic Osteoarthritis, Anterior Cruciate Ligament (ACL) Rupture
- What is being tested?
- Synovial Fluid withdrawal at the preoperative clinic visit, Platelet-Rich Plasma (PRP) preparation and injection and Synovial fluid withdrawal at the time of surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 50
- English-speaking
- Clinical evidence of ACL rupture with swelling
- Participant must be undergoing ACL reconstruction surgery
Who cannot join
- Age <18 or >50
- Presentation >3 weeks after initial injury
- Previous traumatic ipsilateral (same side) knee injury consistent with chronic ACL tear or prior ACL surgery
- > Kellgren-Lawrence grade 2 changes on preoperative x-ray
- History of hemophilia or inflammatory arthropathy (e.g., rheumatoid arthritis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jorge Chahla, MD, PhD contact
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Does Arthrocentesis and PRP For Acute ACL Tears With Hemarthrosis Decrease Inflammatory Cytokines At Time Of Surgery: A Prospective Randomized Control Trial (RCT)
The purpose of this study is to determine what effects the withdrawal of excess knee joint fluid or the injection of a factor from the blood has on swelling after a sudden anterior cruciate ligament (ACL) rupture of the knee.
Read the detailed description
The body responds to different stresses by releasing factors in the blood and fluids in response to stressors like injury, surgery or certain treatments. Some of these factors help heal and some make the injury and body swell (inflammation). In this study we want to see if the intervention of withdrawing fluid the knee or the addition of an enriched healing factor called platelet rich plasma (PRP) injected in the knee influences the body to produce healing factors in the knee joint fluid.
- Being tested
- Synovial Fluid withdrawal at the preoperative clinic visit, Platelet-Rich Plasma (PRP) preparation and injection, Synovial fluid withdrawal at the time of surgery, 3mL synovial fluid withdrawn at the preoperative visit
- Keywords
- osteoarthritis
- Medical subject headings
- Rupture, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synovial Fluid withdrawal at the preoperative clinic visitProcedure or surgery
Also called arthrocentesis
Synovial Fluid withdrawal at the preoperative clinic visit
Platelet-Rich Plasma (PRP) preparation and injectionProcedure or surgery
Also called platelet rich plasma
Platelet-Rich Plasma (PRP) preparation and injection
Synovial fluid withdrawal at the time of surgeryProcedure or surgery
Synovial fluid withdrawal at the time of surgery
3mL synovial fluid withdrawn at the preoperative visitProcedure or surgery
3mL synovial fluid withdrawn at the preoperative visit
| Study group | Role | What they receive |
|---|---|---|
| Two Synovial Fluid Withdrawals | Active comparator | Subjects randomized to Arm 1 will have 2 synovial fluid withdrawals; one at the preoperative clinic visit and one at the time of surgery Receives: Procedure: Synovial Fluid withdrawal at the preoperative clinic visit; Procedure: Synovial fluid withdrawal at the time of surgery |
| Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals | Experimental | Subjects randomized to ARM 2 will have 2 synovial fluid withdrawals one at the preoperative visit and one at the time of surgery. Platelet-Rich Plasma (PRP) preparation and injection will happen at the preoperative clinic visit. Receives: Procedure: Synovial Fluid withdrawal at the preoperative clinic visit; Procedure: Platelet-Rich Plasma (PRP) preparation and injection; Procedure: Synovial fluid withdrawal at the time of surgery |
| 3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery | Other | Subjects randomized to Arm 3 will have 3mL withdrawal of synovial fluid at the preoperative visit and 1 synovial fluid withdrawal at the time of surgery Receives: Procedure: Synovial fluid withdrawal at the time of surgery; Procedure: 3mL synovial fluid withdrawn at the preoperative visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Collagen Type II Cytokine
Breakdown cytokine found in damaged cartilage
Measured: Enrollment up to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial 1:1:1 study assignment (33 subjects Arm 1 two arthrocentesis withdrawals; 33 subjects Arm 2 two arthrocentesis withdrawals with PRP injection; 33 subjects Arm 3 a very small arthocentesis withdrawal and one standard arthrocentesis withdrawal and no PRP injection)
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Responsible party
- Sponsor
- Investigators
- Adam Yanke, MD, PhD, Principal investigator, Associate Professor and Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142369
- Sponsor's protocol ID
- 24120505
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Arthrocentesis and PRP For Acute ACL Tears With Hemarthrosis Decrease Inflammatory Cytokines At Time Of Surgery: A Prospective Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT07142369
- Acronym / sponsor ID
- 24120505
- Keywords
- osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Aug 2025 (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.
The purpose of this study is to determine what effects the withdrawal of excess knee joint fluid or the injection of a factor from the blood has on swelling after a sudden anterior cruciate ligament (ACL) rupture of the knee.
Detailed description
The body responds to different stresses by releasing factors in the blood and fluids in response to stressors like injury, surgery or certain treatments. Some of these factors help heal and some make the injury and body swell (inflammation). In this study we want to see if the intervention of withdrawing fluid the knee or the addition of an enriched healing factor called platelet rich plasma (PRP) injected in the knee influences the body to produce healing factors in the knee joint fluid.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized control trial 1:1:1 study assignment (33 subjects Arm 1 two arthrocentesis withdrawals; 33 subjects Arm 2 two arthrocentesis withdrawals with PRP injection; 33 subjects Arm 3 a very small arthocentesis withdrawal and one standard arthrocentesis withdrawal and no PRP injection)
| Arm | Type | Receives |
|---|---|---|
| Two Synovial Fluid Withdrawals | Active comparator | Procedure: Synovial Fluid withdrawal at the preoperative clinic visit, Procedure: Synovial fluid withdrawal at the time of surgerySubjects randomized to Arm 1 will have 2 synovial fluid withdrawals; one at the preoperative clinic visit and one at the time of surgery |
| Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals | Experimental | Procedure: Synovial Fluid withdrawal at the preoperative clinic visit, Procedure: Platelet-Rich Plasma (PRP) preparation and injection, Procedure: Synovial fluid withdrawal at the time of surgerySubjects randomized to ARM 2 will have 2 synovial fluid withdrawals one at the preoperative visit and one at the time of surgery. Platelet-Rich Plasma (PRP) preparation and injection will happen at the preoperative clinic visit. |
| 3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery | Other | Procedure: Synovial fluid withdrawal at the time of surgery, Procedure: 3mL synovial fluid withdrawn at the preoperative visitSubjects randomized to Arm 3 will have 3mL withdrawal of synovial fluid at the preoperative visit and 1 synovial fluid withdrawal at the time of surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 - 50
- English-speaking
- Clinical evidence of ACL rupture with swelling
- Participant must be undergoing ACL reconstruction surgery
Key exclusion criteria (5 listed)
- Age <18 or >50
- Presentation >3 weeks after initial injury
- Previous traumatic ipsilateral (same side) knee injury consistent with chronic ACL tear or prior ACL surgery
- > Kellgren-Lawrence grade 2 changes on preoperative x-ray
- History of hemophilia or inflammatory arthropathy (e.g., rheumatoid arthritis)
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 |
|---|---|---|
| Synovial Fluid withdrawal at the preoperative clinic visitAlso: arthrocentesisSynovial Fluid withdrawal at the preoperative clinic visit | Procedure or surgery | Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals, Two Synovial Fluid Withdrawals |
| Platelet-Rich Plasma (PRP) preparation and injectionAlso: platelet rich plasmaPlatelet-Rich Plasma (PRP) preparation and injection | Procedure or surgery | Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals |
| Synovial fluid withdrawal at the time of surgerySynovial fluid withdrawal at the time of surgery | Procedure or surgery | 3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery, Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals, Two Synovial Fluid Withdrawals |
| 3mL synovial fluid withdrawn at the preoperative visit3mL synovial fluid withdrawn at the preoperative visit | Procedure or surgery | 3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery |
Primary outcome
Concentration of Collagen Type II Cytokine
Time frame: Enrollment up to surgery
Breakdown cytokine found in damaged cartilage
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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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.
Jorge Chahla, MD, PhD contact
Adam Yanke, MD, PhD principal investigator
Associate Professor and Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synovial Fluid withdrawal at the preoperative clinic visit, Platelet-Rich Plasma (PRP) preparation and injection and Synovial fluid withdrawal at the time of surgery in people with Posttraumatic Osteoarthritis and Anterior Cruciate Ligament (ACL) Rupture, run by Rush University Medical Center 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Yanke, MD, PhD ((312) 432-2818, cartilage.restoration@rushortho.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Collagen Type II Cytokine (time frame: Enrollment up to surgery). 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 Jun 2026.