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

Rush

Status: Not yet enrolling

Conditions: Posttraumatic Osteoarthritis; Anterior Cruciate Ligament (ACL) Rupture

Treatments: Procedure: Synovial fluid withdrawal at the time of surgery; Procedure: Synovial Fluid withdrawal at the preoperative clinic visit; Procedure: 3mL synovial fluid withdrawn at the preoperative visit; Procedure: Platelet-Rich Plasma (PRP) preparation and injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07142369

24120505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 3 patient groups

Two Synovial Fluid Withdrawals

Active Comparator group

Description:

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

Treatment:

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 group

Description:

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.

Treatment:

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

Procedure: Synovial Fluid withdrawal at the preoperative clinic visit

Procedure: Synovial fluid withdrawal at the time of surgery

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

Other group

Description:

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

Treatment:

Procedure: 3mL synovial fluid withdrawn at the preoperative visit

Procedure: Synovial fluid withdrawal at the time of surgery