Meniscus TearPhase 2PROPERNCT05149287
PROPER Trial of Pain and Inflammation After Knee Arthroscopy
A Phase 2 study testing Ceftriaxone in people with Meniscus Tear and Meniscus Lesion, run by Austin V Stone at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Tear, Meniscus Lesion, Cartilage Injury
- What is being tested?
- Ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2021to 29 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Reduction of Post-opeRative Pain and Inflammation to Expedite Return to Function After KNEE Arthroscopy
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.
Read the 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.
- Conditions
- Meniscus Tear, Meniscus Lesion, Cartilage Injury
- Being tested
- Ceftriaxone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
single intravenous dose of 1 g of ceftriaxone
PlaceboOther
Also called Lidocaine and Saline
1% lidocaine and saline
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 5-12 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start28 Dec 2021
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Why it stopped: Funding stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin V Stone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Austin V Stone, University of Kentucky
- Investigators
- Austin V Stone, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149287
- Sponsor's protocol ID
- 63476
- Acronym
- PROPER
- Status last verified
- Aug 2023
- First submitted
- 24 Nov 2021
- Last updated
- 5 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Reduction of Post-opeRative Pain and Inflammation to Expedite Return to Function After KNEE Arthroscopy
- ClinicalTrials.gov ID
- NCT05149287
- Acronym / sponsor ID
- PROPER / 63476
- Conditions
- Meniscus Tear, Meniscus Lesion, Cartilage Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding stopped
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Austin V StoneUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Posted 5 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: CeftriaxoneThe experimental group will receive a single intravenous dose of 1 g of ceftriaxone immediately postoperative in the operating room. |
| Placebo | Placebo comparator | Other: PlaceboThe placebo group will receive a single intravenous dose of 1% lidocaine and saline immediately postoperative in the operating room. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftriaxonesingle intravenous dose of 1 g of ceftriaxone | Drug | Experimental |
| PlaceboAlso: Lidocaine and Saline1% lidocaine and saline | Other | Placebo |
Primary outcome
Change in Visual Analog Scale (VAS) Pain Score
Time frame: Pre-operative, 2 months post-operative
The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain.
Change in RU SATED Score
Time frame: Pre-operative, 2 months post-operative
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
Time frame: 5-12 days post-operative
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Austin V Stone, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ceftriaxone in people with Meniscus Tear and Meniscus Lesion, run by Austin V Stone at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Pain Score (time frame: Pre-operative, 2 months post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.