PROPER Trial of Pain and Inflammation After Knee Arthroscopy
Condition: Meniscus Tear; Meniscus Lesion; Cartilage Injury
MeSH terms: Inflammation
Intervention: Ceftriaxone; Placebo
Intervention description: single intravenous dose of 1 g of ceftriaxone; 1% lidocaine and saline
Intervention MeSH terms: Ceftriaxone; Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After providing informed consent, patients undergoing arthroscopy of the knee for meniscal or cartilage injuries will be randomized into one of two groups. At the time of surgery, while the patient is under anesthesia, one group will receive a single intravenous dose of 1 gram of ceftriaxone and the other will receive a single intravenous dose of 1% lidocaine in saline.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: One group will receive an intravenous dose of ceftriaxone and the other will receive an intravenous dose of lidocaine in saline. The syringes will be blinded to ensure that both the investigator administering the injection and the patient will be blinded to the group assignment.
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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