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

NCT ID: NCT07142369

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Posttraumatic Osteoarthritis Anterior Cruciate Ligament (ACL) Rupture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Synovial Fluid withdrawal at the preoperative clinic visit

Intervention Type PROCEDURE

Synovial Fluid withdrawal at the preoperative clinic visit

Synovial fluid withdrawal at the time of surgery

Intervention Type PROCEDURE

Synovial fluid withdrawal at the time of surgery

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.

Group Type EXPERIMENTAL

Synovial Fluid withdrawal at the preoperative clinic visit

Intervention Type PROCEDURE

Synovial Fluid withdrawal at the preoperative clinic visit

Platelet-Rich Plasma (PRP) preparation and injection

Intervention Type PROCEDURE

Platelet-Rich Plasma (PRP) preparation and injection

Synovial fluid withdrawal at the time of surgery

Intervention Type PROCEDURE

Synovial fluid withdrawal at the time of surgery

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

Group Type OTHER

Synovial fluid withdrawal at the time of surgery

Intervention Type PROCEDURE

Synovial fluid withdrawal at the time of surgery

3mL synovial fluid withdrawn at the preoperative visit

Intervention Type PROCEDURE

3mL synovial fluid withdrawn at the preoperative visit

Interventions

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Synovial Fluid withdrawal at the preoperative clinic visit

Synovial Fluid withdrawal at the preoperative clinic visit

Intervention Type PROCEDURE

Platelet-Rich Plasma (PRP) preparation and injection

Platelet-Rich Plasma (PRP) preparation and injection

Intervention Type PROCEDURE

Synovial fluid withdrawal at the time of surgery

Synovial fluid withdrawal at the time of surgery

Intervention Type PROCEDURE

3mL synovial fluid withdrawn at the preoperative visit

3mL synovial fluid withdrawn at the preoperative visit

Intervention Type PROCEDURE

Other Intervention Names

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arthrocentesis platelet rich plasma

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arthroscopy Association of North America (AANA)

UNKNOWN

Sponsor Role collaborator

Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adam Yanke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor and Surgeon

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Central Contacts

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Adam Yanke, MD, PhD

Role: CONTACT

(312) 432-2818

Jorge Chahla, MD, PhD

Role: CONTACT

Other Identifiers

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24120505

Identifier Type: -

Identifier Source: org_study_id

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