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| Name | Class |
|---|---|
| Arthroscopy Association of North America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synovial Fluid withdrawal at the preoperative clinic visit | Procedure | Synovial Fluid withdrawal at the preoperative clinic visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Collagen Type II Cytokine | Breakdown cytokine found in damaged cartilage | Enrollment up to surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Yanke, MD, PhD | Contact | (312) 432-2818 | cartilage.restoration@rushortho.com | |
| Jorge Chahla, MD, PhD | Contact | jorge.chahla@rushortho.com |
| Name | Affiliation | Role |
|---|---|---|
| Adam Yanke, MD, PhD | Associate Professor and Surgeon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
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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)
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| Platelet-Rich Plasma (PRP) preparation and injection | Procedure | Platelet-Rich Plasma (PRP) preparation and injection |
|
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| Synovial fluid withdrawal at the time of surgery | Procedure | Synovial fluid withdrawal at the time of surgery |
|
| 3mL synovial fluid withdrawn at the preoperative visit | Procedure | 3mL synovial fluid withdrawn at the preoperative visit |
|
| ID | Term |
|---|---|
| D012421 | Rupture |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069237 | Arthrocentesis |
| D007267 | Injections |
| ID | Term |
|---|---|
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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