PROPER Trial of Pain and Inflammation After Knee Arthroscopy

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if ceftriaxone administered postoperatively via intravenous injection reduces postoperative visual analog scale (VAS) pain scores and narcotic consumption in patients undergoing knee arthroscopy for a cartilage or meniscal injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Austin V Stone
• Treatments: Ceftriaxone; Lidocaine

Criteria

Inclusion Criteria:

1. Written consent to participate in the study

2. Male or female greater than or equal to 18 years of age and less than 55 years of age

3. Is indicated for knee arthroscopy for cartilage or meniscal procedure

4. Ambulatory and in good general health

5. Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions.

6. Willing to abstain from use of protocol-restricted medications during the study

Exclusion Criteria:

1. Known allergic reactions to cephalosporins

2. Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease

3. History of infection in either knee joint

4. Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening

5. Other surgery or arthroscopy of either knee within 6 months of Screening

6. Intraarticular treatment of any joint with any of the following agents within six (6) months of Screening: any corticosteroid preparation or any biologic agent (e.g., platelet rich plasma (PRP) injection, stem cells, prolotherapy, amniotic fluid injection; investigational or marketed).

7. Intraarticular treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening

8. Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening

9. Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening

10. Females who are pregnant or nursing or plan to become pregnant during the study; men whose female partner plans to conceive during the study

11. Radiographic osteoarthritic changes defined as Kellgren-Lawrence grade 2 or greater (as determined by PI from patient's preoperative X-rays)

12. Inability to read and understand English

13. Any prior diagnosis of antibiotic-resistant diarrhea