Post-Operative Pain ManagementNCT04191031
Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty
A study testing ioveraº in people with Post-Operative Pain Management, run by Pacira Pharmaceuticals, Inc at 7 sites in United States.
Trial summary
Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Post-Operative Pain Management
- What is being tested?
- ioveraº
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Sep 2020to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 22 years of age at screening.
- Scheduled to undergo primary, unilateral, tricompartmental TKA under spinal anesthesia.
- Primary indication for TKA is degenerative osteoarthritis of the knee.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Anticipation of discharge to home after inpatient acute postsurgical phase based on age, comorbidities, home environment, social support, and the judgment of the Investigator.
- Females of childbearing potential must have a negative pregnancy test result prior to enrollment and agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year). Post-menopausal or surgically sterile females would not require a pregnancy test.
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
Who cannot join
- History of prior contralateral TKA within 6 months or open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
- Planned concurrent surgical procedure (e.g., bilateral TKA) or planned additional surgery within 90 days of study surgery.
- Undergoing unicompartmental TKA or revision TKA.
- Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery).
- Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study and postsurgical rehabilitation.
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications (i.e., bupivacaine, lidocaine, acetaminophen, tranexamic acid, celecoxib, naproxen, meloxicam).
Show all 30Show fewer
- Use of any of the following medications within the times specified before TKA: long-acting and short-acting opioid medications within 6 weeks; or NSAIDs (except for low-dose aspirin used for cardioprotection) within 3 days or 5 elimination half-lives, whichever is longer.
- Initiation of treatment with any of the following medications within 1 month prior to the screening visit or ongoing concomitant use if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, he or she must be on a stable dose for at least 1 month prior to screening visit.
- Current use of systemic glucocorticosteroids within 1 month prior to screening in this study, intra-articular corticosteroid injections within 6 weeks, or Zilretta within 3 months.
- History of coronary or vascular stent placed within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
- Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
- Any clotting disorder and/or use of an anticoagulant (e.g. warfarin, clopidogrel, etc.) within seven (7) days prior to administration of ioveraº treatment.
- Rheumatoid or inflammatory arthritis.
- History of severely impaired renal or hepatic function (in the judgment of the investigator).
- Any neurologic or psychiatric disorder that might affect postsurgical pain or interfere with study assessments.
- Malignancy in the last 2 years, per physician discretion.
- History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol within the past 2 years.
- Use of marijuana, including medical use, within 6 weeks prior to screening visit or continuation thereafter.
- Body weight <50 kg (110 pounds) or a body mass index >40 kg/m2.
- Previous iovera° treatment.
- Greater than 15° malalignment (varus or valgus) on presurgical radiograph.
- Prior surgery in the treatment areas that may have altered the anatomy of nerves intended to be treated with the ioveraº system or result in scar tissue in the treatment area.
- Open and/or infected wounds at or near the treatment site.
- Any other local skin condition at the treatment sites that in the Investigator's judgment would adversely affect treatment or outcomes.
- History of cryoglobulinemia.
- History of paroxysmal cold hemoglobinuria.
- History of cold urticaria.
- History of Raynaud's disease.
- Administration of an investigational product within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to screening, or planned administration of another investigational product or procedure during the subject's participation in this study
- Given the COVID-19 pandemic, the subject must be medically fit/cleared for surgery by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded per Exclusion criterion #5.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
First Surgical Hospital
Bellaire, Texas, 77401
Legent Orthopedic Hospital
Carrollton, Texas, 75006
Sah Orthopaedic Associates at the Institute for Joint Restoration
Fremont, California, 94538
Northwell Health
New York, New York, 10075
Lotus Clinical Research
Pasadena, California, 91105
Phoenix Clinical Research
Tamarac, Florida, 33321
Towson Orthopaedic Associates
Towson, Maryland, 21204
About this study
Official title: A Multicenter, Double-blind, Randomized, Sham-controlled Study Assessing Opioid Utilization, Postoperative Pain and Function in Subjects Undergoing Total Knee Arthroplasty Treated With Presurgical Iovera®° or Sham Iovera®° Cryoneurolysis and Postsurgical Multimodal Pain Regimen
Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA).
Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption, opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy, in subjects undergoing primary unilateral TKA
Read the detailed description
This is a multicenter, double-blind, randomized, sham-controlled study in adult subjects undergoing TKA. Approximately 200 subjects are planned for enrollment and will be randomized 1:1 to receive presurgical ioveraº treatment or sham ioveraº treatment. An unblinded interim analysis will be performed when approximately 60 randomized and treated subjects have completed the Day 30 assessments. Based on the results of the interim analysis, sample size re-estimation will be performed and one of the following will occur: (1) the study will proceed to the final analysis without additional interim analysis, (2) the study will proceed to the second interim analysis once a defined number of additional subjects have completed Day 30 assessments, at which time, the study may be stopped for success or futility or proceed to the final analysis (3) the study will be stopped for futility. The detailed decision rules are defined in response to the interim analysis statistical analysis plan (IA SAP).
This study is designed to investigate whether presurgical iovera° cryoneurolysis treatment leads to less postsurgical opioid consumption, decreased pain after surgery, improved function, and improved postsurgical outcomes compared with subjects who undergo presurgical sham iovera° treatment. All subjects will receive postsurgical multimodal pain medications and intraoperative local infiltration with EXPAREL (bupivacaine liposome injectable suspension).
Subjects may be screened within 60 days prior to TKA. No procedures other than the site's standard of care will be performed before signed informed consent is obtained. When screening test results are received and the subject is deemed eligible for the study, the subject will be notified that he or she can be enrolled in the study.
Subjects may be rescreened upon sponsor approval for administrative reasons.
Randomization to treatment groups and treatment with the iovera° system according to the randomization assignment will be performed prior to TKA. The treatment groups are:
- Group 1: subjects will receive iovera° cryoneurolysis treatment of superficial genicular nerves of the target knee
- Group 2: subjects will receive sham iovera° treatment of superficial genicular nerves of the target knee
At the subsequent TKA, all subjects in both groups will receive intraoperative local infiltration with EXPAREL and postsurgical multimodal pain medications.
After discharge, subjects will be followed for 90 days. Subjects will be assessed for safety, efficacy, and health outcomes parameters.
- Conditions
- Post-Operative Pain Management
- Being tested
- ioveraº, ioveraº sham
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Iovera
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ioveraºDevice
Cryoneurolysis
ioveraº shamDevice
ioveraº sham
| Study group | Role | What they receive |
|---|---|---|
| Superficial Genicular Nerves | Experimental | Subjects will receive iovera° cryoneurolysis treatment of superficial genicular nerves (anterior femoral cutaneous nerve [AFCN] and infrapatellar branches of the saphenous nerve [ISN]) of the target knee Receives: Device: ioveraº |
| Sham Comparator | Sham comparator | Subjects will receive sham iovera° treatment of superficial genicular nerves (AFCN and ISN) of the target knee Receives: Device: ioveraº sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 30.
Measured: Day 1 to Day 30
Secondary outcomes (12)
Change of KOOS scores (English version LK 1.0) from TKA Pre-Surgery visit to Day 30 visit post-TKA
Measured: Day -3 to Day 30
NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 15, Day 42, and Day 90.
Measured: Day 1 to Day 90
NRS "average pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 15, Day 30, Day 42, and Day 90
Measured: Day 1 to Day 90
Change of NRS current pain intensity scores (pain "right now") from pre-treatment to post-treatment at the iovera/sham treatment visit
Measured: Day 1 to Day 90
Total postsurgical opioid consumption in oral morphine equivalents through Day 15, Day 30, Day 42, and Day 90
Measured: Day 1 to Day 90
Percentage of subjects who are opioid free from post-TKA through Day 30
Measured: Day 1 to Day 30
Change of KOOS scores from screening visit to each of the following visits: TKA Pre-Surgery, Day 15, Day 30, Day 42, and Day 90
Measured: Day -3 to Day 90
Physical function (pain with 10 M walk, pain with passive range of motion (ROM) to 90° or 110° and active ROM maximum degrees of flexion) at the following visits: Day 15, Day 30, Day 42, and Day 90.
Measured: Day 15 to Day 90
Acute postoperative sleep quality by NRS daily through the first 7 days post TKA
Measured: Day 1 to Day 8
Change of extended postoperative sleep quality by PROMIS 8A scores from screening visit to each of the following visits: TKA Pre-Surgery, Day 15, Day 30, Day 42, and Day 90.
Measured: Screening to Day 90
NRS "worst pain" itensity scores from 72 hours post-TKA (Day 4) to Day 30
Measured: Day 4 to Day 30
NRS "average pain" intensity scores from 72 hours post-TKA (Day 4) to Day 30
Measured: Day 4 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start30 Sep 2020
- Primary completion13 May 2022
- Study completion12 Jul 2022
Why it stopped: One of the pre-determined criteria for efficacy analysis in the interim analysis SAP for stopping the study was met.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Pain ManagementStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Nevins, DC, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191031
- Sponsor's protocol ID
- IOV-401
- Status last verified
- Jan 2023
- First submitted
- 26 Nov 2019
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Sham-controlled Study Assessing Opioid Utilization, Postoperative Pain and Function in Subjects Undergoing Total Knee Arthroplasty Treated With Presurgical Iovera®° or Sham Iovera®° Cryoneurolysis and Postsurgical Multimodal Pain Regimen
- ClinicalTrials.gov ID
- NCT04191031
- Acronym / sponsor ID
- IOV-401
- Conditions
- Post-Operative Pain Management
- Keywords
- Total Knee Arthroplasty, Osteoarthritis, Iovera
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: One of the pre-determined criteria for efficacy analysis in the interim analysis SAP for stopping the study was met.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA).
Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption, opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy, in subjects undergoing primary unilateral TKA
Detailed description
This is a multicenter, double-blind, randomized, sham-controlled study in adult subjects undergoing TKA. Approximately 200 subjects are planned for enrollment and will be randomized 1:1 to receive presurgical ioveraº treatment or sham ioveraº treatment. An unblinded interim analysis will be performed when approximately 60 randomized and treated subjects have completed the Day 30 assessments. Based on the results of the interim analysis, sample size re-estimation will be performed and one of the following will occur: (1) the study will proceed to the final analysis without additional interim analysis, (2) the study will proceed to the second interim analysis once a defined number of additional subjects have completed Day 30 assessments, at which time, the study may be stopped for success or futility or proceed to the final analysis (3) the study will be stopped for futility. The detailed decision rules are defined in response to the interim analysis statistical analysis plan (IA SAP).
This study is designed to investigate whether presurgical iovera° cryoneurolysis treatment leads to less postsurgical opioid consumption, decreased pain after surgery, improved function, and improved postsurgical outcomes compared with subjects who undergo presurgical sham iovera° treatment. All subjects will receive postsurgical multimodal pain medications and intraoperative local infiltration with EXPAREL (bupivacaine liposome injectable suspension).
Subjects may be screened within 60 days prior to TKA. No procedures other than the site's standard of care will be performed before signed informed consent is obtained. When screening test results are received and the subject is deemed eligible for the study, the subject will be notified that he or she can be enrolled in the study.
Subjects may be rescreened upon sponsor approval for administrative reasons.
Randomization to treatment groups and treatment with the iovera° system according to the randomization assignment will be performed prior to TKA. The treatment groups are:
- Group 1: subjects will receive iovera° cryoneurolysis treatment of superficial genicular nerves of the target knee
- Group 2: subjects will receive sham iovera° treatment of superficial genicular nerves of the target knee
At the subsequent TKA, all subjects in both groups will receive intraoperative local infiltration with EXPAREL and postsurgical multimodal pain medications.
After discharge, subjects will be followed for 90 days. Subjects will be assessed for safety, efficacy, and health outcomes parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial Genicular Nerves | Experimental | Device: ioveraºSubjects will receive iovera° cryoneurolysis treatment of superficial genicular nerves (anterior femoral cutaneous nerve [AFCN] and infrapatellar branches of the saphenous nerve [ISN]) of the target knee |
| Sham Comparator | Sham comparator | Device: ioveraº shamSubjects will receive sham iovera° treatment of superficial genicular nerves (AFCN and ISN) of the target knee |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, at least 22 years of age at screening.
- Scheduled to undergo primary, unilateral, tricompartmental TKA under spinal anesthesia.
- Primary indication for TKA is degenerative osteoarthritis of the knee.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Anticipation of discharge to home after inpatient acute postsurgical phase based on age, comorbidities, home environment, social support, and the judgment of the Investigator.
Key exclusion criteria (30 listed)
- History of prior contralateral TKA within 6 months or open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
- Planned concurrent surgical procedure (e.g., bilateral TKA) or planned additional surgery within 90 days of study surgery.
- Undergoing unicompartmental TKA or revision TKA.
- Concurrent painful physical condition that may require analgesic treatment (such as an NSAID or opioid) in the postsurgical period for pain that is not strictly related to the knee surgery and which may confound the postsurgical assessments (e.g., significant pain from other joints including the non-index knee joint, chronic neuropathic pain, concurrent or prior contralateral TKA, concurrent foot surgery).
- Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study and postsurgical rehabilitation.
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 |
|---|---|---|
| ioveraºCryoneurolysis | Device | Superficial Genicular Nerves |
| ioveraº shamioveraº sham | Device | Sham Comparator |
Primary outcome
NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 30.
Time frame: Day 1 to Day 30
12 secondary outcomes
Change of KOOS scores (English version LK 1.0) from TKA Pre-Surgery visit to Day 30 visit post-TKA
Time frame: Day -3 to Day 30
NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 15, Day 42, and Day 90.
Time frame: Day 1 to Day 90
NRS "average pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 15, Day 30, Day 42, and Day 90
Time frame: Day 1 to Day 90
Change of NRS current pain intensity scores (pain "right now") from pre-treatment to post-treatment at the iovera/sham treatment visit
Time frame: Day 1 to Day 90
Total postsurgical opioid consumption in oral morphine equivalents through Day 15, Day 30, Day 42, and Day 90
Time frame: Day 1 to Day 90
Percentage of subjects who are opioid free from post-TKA through Day 30
Time frame: Day 1 to Day 30
Change of KOOS scores from screening visit to each of the following visits: TKA Pre-Surgery, Day 15, Day 30, Day 42, and Day 90
Time frame: Day -3 to Day 90
Physical function (pain with 10 M walk, pain with passive range of motion (ROM) to 90° or 110° and active ROM maximum degrees of flexion) at the following visits: Day 15, Day 30, Day 42, and Day 90.
Time frame: Day 15 to Day 90
Acute postoperative sleep quality by NRS daily through the first 7 days post TKA
Time frame: Day 1 to Day 8
Change of extended postoperative sleep quality by PROMIS 8A scores from screening visit to each of the following visits: TKA Pre-Surgery, Day 15, Day 30, Day 42, and Day 90.
Time frame: Screening to Day 90
NRS "worst pain" itensity scores from 72 hours post-TKA (Day 4) to Day 30
Time frame: Day 4 to Day 30
NRS "average pain" intensity scores from 72 hours post-TKA (Day 4) to Day 30
Time frame: Day 4 to Day 30
Results and safety
The study was stopped early (reason given: One of the pre-determined criteria for efficacy analysis in the interim analysis SAP for stopping the study was met.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- 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.
Gary Nevins, DC study director
Pacira Pharmaceuticals, Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ioveraº in people with Post-Operative Pain Management, run by Pacira Pharmaceuticals, Inc at 7 sites 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 7 inclusion and 30 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 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
The study was stopped early (reason given: One of the pre-determined criteria for efficacy analysis in the interim analysis SAP for stopping the study was met.). Results are not available in the source record.
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?
NRS "worst pain" intensity scores from first pain assessment post-TKA (Day 1) to Day 30. (time frame: Day 1 to Day 30). 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 25 Jan 2023.