PROPER Trial of Pain and Inflammation After Knee Arthroscopy

NCT05149287 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 63476
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meniscus Tear; Meniscus Lesion; Cartilage Injury

Outcome Measures

Primary Outcomes (3)

• Change in Visual Analog Scale (VAS) Pain Score

  The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain.

  Pre-operative, 2 months post-operative

• Change in RU SATED Score

  The Regularity, Sleep Quality, Alertness, Timing, Efficiency, Duration scale for sleep (RU SATED) ranges from 0 to 30, with higher scores indicating better sleep health.

  Pre-operative, 2 months post-operative

• Post-operative Narcotic Use

  Post-operative narcotic use will be monitored with self-reported medication consumption at the first post-operative visit, which will take place 5-12 days post-operative. The milligrams of morphine equivalent (MME) will be calculated based on patient responses with greater MME indicative of increased postoperative use of narcotic pain medications.

  5-12 days post-operative

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.

Drug: Ceftriaxone

Placebo

PLACEBO COMPARATOR

The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.

Other: Placebo

Interventions

Ceftriaxone DRUG

single intravenous dose of 1 g of ceftriaxone

Experimental

Placebo OTHER

1% lidocaine and saline

Also known as: Lidocaine and Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Austin V Stone: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Interventions

Ceftriaxone; Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Austin Stone
• Organization: University of Kentucky

austin.stone@uky.edu

(859) 323-5533

Study Officials

• Austin V Stone, MD, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: December 28, 2021
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: September 5, 2023
• Results First Posted: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Access to individual participant data will be available 1 year after the final study follow-up has been completed, and will be available until 5 years after the final study follow-up has been completed.
• Access Criteria: The researchers requesting access to participant information or samples must complete a questionnaire describing why they need information or samples for their research and how they will use the information or samples. The researchers who receive the information or samples will sign an agreement to use the data responsibly.

Locations

US (1)