Arthropathy of Knee JointNCT03647709
Opioid-free Accelerated Recovery Total Knee Arthroplasty
An observational study of Arthropathy of Knee Joint, run by St. Elizabeth Medical Center, Utica, NY at 1 site in United States.
Trial summary
To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- opioids
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Apr 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A Partial and total knee arthroplasty Unilateral only
Who may be able to join
- Surgeries to be performed at hospital
- Surgeries to be performed at surgery center
- Ability to read and understand English
- Primary care clearance for patients diagnosed with high blood pressure
Who cannot join
- Disease states, patient conditions to exclude:
- Schizophrenia Bipolar Disease Dementia
- Known allergies to local anesthetics
- Previous burn to affected extremity
- BMI > 40
- Nonoptimized anemia
- Albumin less than 3.5
- A1C > 8.0
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid-Free Accelerated Recovery Total Knee Arthroplasty
To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.
Read the detailed description
All study patients will receive a standardized protocol
- All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center
- Will attempt to minimize the number of anesthesiologists to further control variability in care
Methods:
- Pre-op Optimization
- All patients enroll in education program
- All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure
- Total Joint Procedure
- Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block
- Data Collection
- Electronic medical record chart review
- Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge
- Phone calls after discharge
- Follow-up assessment in surgeon's office
- Swift path / KOOS JR surveys
- Pain Management Regimen
- pre-op physical therapy teaching
- post-op multimodal pain regimen
- Conditions
- Arthropathy of Knee Joint
- Being tested
- opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioidsOther
dosage frequency and duration
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative
Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols
Measured: 12 weeks
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative
The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative
Measured: 12 weeks
Secondary outcomes (7)
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity
Pain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery.
Measured: postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)
The Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome.
Measured: Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery
Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement
Swift path is an Educational tool (diary) for patients undergoing total joint replacement, that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery.
Measured: 6 weeks
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Measured: Postop Days10-14
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Measured: postoperative 3 weeks
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Measured: Postoperative 6 weeks
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12
Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.
Measured: Postoperative 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Oct 2018
- Primary completion30 Oct 2019
- Study completion30 Apr 2020
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 Arthropathy of Knee JointStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Elizabeth Medical Center, Utica, NY
- Sponsor type
- University, hospital or other
- Collaborators
- Halyard Health
- Responsible party
- Principal investigator, Dr Andrew B. Wickline, St. Elizabeth Medical Center, Utica, NY
- Investigators
- Andrew B Wickline, MD, Principal investigator, St Elizabeth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647709
- Sponsor's protocol ID
- qllS
- Status last verified
- May 2020
- First submitted
- 9 Aug 2018
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Free Accelerated Recovery Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03647709
- Acronym / sponsor ID
- qllS
- Conditions
- Arthropathy of Knee Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- St. Elizabeth Medical Center, Utica, NYUniversity, hospital or other
- Collaborators
- Halyard Health
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.
Detailed description
All study patients will receive a standardized protocol
- All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center
- Will attempt to minimize the number of anesthesiologists to further control variability in care
Methods:
- Pre-op Optimization
- All patients enroll in education program
- All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure
- Total Joint Procedure
- Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block
- Data Collection
- Electronic medical record chart review
- Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge
- Phone calls after discharge
- Follow-up assessment in surgeon's office
- Swift path / KOOS JR surveys
- Pain Management Regimen
- pre-op physical therapy teaching
- post-op multimodal pain regimen
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A Partial and total knee arthroplasty Unilateral only
Key inclusion criteria (4 listed)
- Surgeries to be performed at hospital
- Surgeries to be performed at surgery center
- Ability to read and understand English
- Primary care clearance for patients diagnosed with high blood pressure
Key exclusion criteria (8 listed)
- Disease states, patient conditions to exclude:
- Schizophrenia Bipolar Disease Dementia
- Known allergies to local anesthetics
- Previous burn to affected extremity
- BMI > 40
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 |
|---|---|---|
| opioidsdosage frequency and duration | Other | – |
Primary outcome
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative
Time frame: 12 weeks
Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative
Time frame: 12 weeks
The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative
7 secondary outcomes
Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity
Time frame: postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery
Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)
Time frame: Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery
Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement
Time frame: 6 weeks
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14
Time frame: Postop Days10-14
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3
Time frame: postoperative 3 weeks
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6
Time frame: Postoperative 6 weeks
Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12
Time frame: Postoperative 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Andrew B Wickline, MD principal investigator
St Elizabeth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Knee Joint, run by St. Elizabeth Medical Center, Utica, NY 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 12 May 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2020). 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?
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative (time frame: 12 weeks). The study lists 2 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 12 May 2020.