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

NCT07142369 | Not Yet Recruiting

• 1 other identifier: 24120505
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Osteoarthritis; Anterior Cruciate Ligament (ACL) Rupture

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Concentration of Collagen Type II Cytokine

  Breakdown cytokine found in damaged cartilage

  Enrollment up to surgery

Study Arms (3)

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

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.

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

Procedure: Synovial fluid withdrawal at the time of surgery; Procedure: 3mL synovial fluid withdrawn at the preoperative visit

Interventions

Synovial Fluid withdrawal at the preoperative clinic visit PROCEDURE

Synovial Fluid withdrawal at the preoperative clinic visit

Also known as: arthrocentesis

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

Platelet-Rich Plasma (PRP) preparation and injection PROCEDURE

Platelet-Rich Plasma (PRP) preparation and injection

Also known as: platelet rich plasma

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

Synovial fluid withdrawal at the time of surgery PROCEDURE

Synovial fluid withdrawal at the time of 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 visit PROCEDURE

3mL synovial fluid withdrawn at the preoperative visit

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arthroscopy Association of North America (AANA): collaborator
• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Rupture; Osteoarthritis

Interventions

Arthrocentesis; Injections

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Drug Administration Routes; Drug Therapy

Study Officials

• Adam Yanke, MD, PhD

  Associate Professor and Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Yanke, MD, PhD

CONTACT

(312) 432-2818; cartilage.restoration@rushortho.com

Jorge Chahla, MD, PhD

CONTACT

jorge.chahla@rushortho.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)