PROPER Trial of Pain and Inflammation After Knee Arthroscopy (PROPER)

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    48
  • sponsor
    Austin V Stone
Updated on 25 March 2022
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.

Description

Arthroscopic surgery for cartilage and meniscus injuries are some of the most common orthopaedic procedures currently performed. Post-surgical pain is initiated through an inflammatory response to surgery. The pain response leads to sleep disruption and a further increase in pain and additional sleep disruption. Opioid medications are often used after surgery to treat pain despite the side effect profile. These medications also contribute to poor sleep quality and duration. Early pain and narcotic use can be controlled by mitigating the effects of post-surgical inflammation. Ceftriaxone is a readily available antibiotic and may have the desirable anti-inflammatory and analgesic effects, but without the side effects caused by other medications. Since it is highly selective in its inhibition, ceftriaxone is an excellent candidate for reducing immediate post-operative pain and heightened inflammatory response.

By doing this study, the investigators hope to learn about the anti-inflammatory effectiveness of the antibiotic ceftriaxone. Ceftriaxone has been shown to inhibit a key enzyme in the post-operative inflammatory process and has been safely used for treatment of infections for years. The investigators would like to gather information about whether ceftriaxone helps reduce pain and inflammation after surgery. Participation in this research will last about 2 months.

Details
Condition Meniscus Tear, Meniscus Lesion, Cartilage Injury
Treatment Placebo, ceftriaxone
Clinical Study IdentifierNCT05149287
SponsorAustin V Stone
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written consent to participate in the study
Male or female greater than or equal to 18 years of age and less than 55 years of age
Is indicated for knee arthroscopy for cartilage or meniscal procedure
Ambulatory and in good general health
Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
Willing to abstain from use of protocol-restricted medications during the study

Exclusion Criteria

Known allergic reactions to cephalosporins
Reactive arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
History of infection in either knee joint
Clinical signs and symptoms of active knee infection or crystal disease in either knee within 1 month of Screening
Other surgery or arthroscopy of either knee within 6 months of Screening
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)
Intraarticular treatment in either knee with hyaluronic acid (investigational or marketed) within 6 months of Screening
Parenteral or oral corticosteroids (investigational or marketed) within 3 months of Screening
Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Females who are pregnant or nursing or plan to become pregnant during the study; men whose female partner plans to conceive during the study
Radiographic osteoarthritic changes defined as Kellgren-Lawrence grade 2 or greater (as determined by PI from patient's preoperative X-rays)
Inability to read and understand English
Any prior diagnosis of antibiotic-resistant diarrhea
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