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

Primary Purpose

Meniscus Tear, Meniscus Lesion, Cartilage Injury

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ceftriaxone
Placebo
Sponsored by
Austin V Stone
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscus Tear

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2021
Last Updated
August 11, 2023
Sponsor
Austin V Stone
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1. Study Identification

Unique Protocol Identification Number
NCT05149287
Brief Title
PROPER Trial of Pain and Inflammation After Knee Arthroscopy
Acronym
PROPER
Official Title
Early Reduction of Post-opeRative Pain and Inflammation to Expedite Return to Function After KNEE Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding stopped
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
April 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Austin V Stone

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Tear, Meniscus Lesion, Cartilage Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room.
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Intervention Description
single intravenous dose of 1 g of ceftriaxone
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lidocaine and Saline
Intervention Description
1% lidocaine and saline
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Pain Score
Description
The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain.
Time Frame
Pre-operative, 2 months post-operative
Title
Change in RU SATED Score
Description
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.
Time Frame
Pre-operative, 2 months post-operative
Title
Post-operative Narcotic Use
Description
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.
Time Frame
5-12 days post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Austin V Stone, MD, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
With the participant's approval and as approved by local Institutional Review Boards (IRBs), de-identified biological samples will be stored at the University of Kentucky Orthopedic Biomarker Repository. These samples could be used to research the causes of osteoarthritis after cartilage or meniscus injury, its complications and other conditions for which individuals with cartilage or meniscus injuries are at increased risk, and to improve treatment. Before sharing biomarker samples, we will ensure that the participant has given previous consent to the sharing of the information or samples. When we confirm that the previously provided consent is still in effect we will remove identifiers such as (e.g., name, medical record number, or date of birth). We will use a secure electronic log to track information shared without releasing the individual participant's identity.
IPD Sharing 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.
IPD Sharing 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.

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PROPER Trial of Pain and Inflammation After Knee Arthroscopy

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