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Synovial Fluid Withdrawal or PRP Injection For Acute ACL Tears and Cytokines

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 50 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 18 - 50.
  • - English-speaking.
  • - Clinical evidence of ACL rupture with swelling.
  • - Participant must be undergoing ACL reconstruction surgery.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07142369
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Rush University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Adam Yanke, MD, PhD
Principal Investigator Affiliation Associate Professor and Surgeon
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Posttraumatic Osteoarthritis, Anterior Cruciate Ligament (ACL) Rupture
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Two Synovial Fluid Withdrawals

Subjects randomized to Arm 1 will have 2 synovial fluid withdrawals; one at the preoperative clinic visit and one at the time of surgery

Experimental: Platelet-Rich Plasma (PRP) and Two Synovial Fluid Withdrawals

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.

Other: 3mL Synovial Fluid Withdrawal and Synovial Fluid Withdrawal at the Time of Surgery

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

Interventions

Procedure: - Synovial Fluid withdrawal at the preoperative clinic visit

Synovial Fluid withdrawal at the preoperative clinic visit

Procedure: - Platelet-Rich Plasma (PRP) preparation and injection

Platelet-Rich Plasma (PRP) preparation and injection

Procedure: - Synovial fluid withdrawal at the time of surgery

Synovial fluid withdrawal at the time of surgery

Procedure: - 3mL synovial fluid withdrawn at the preoperative visit

3mL synovial fluid withdrawn at the preoperative visit

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago 4887398, Illinois 4896861

Status

Address

Rush University Medical Center

Chicago 4887398, Illinois 4896861, 60612

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