Arthritis of the KneeNCT02284113
A Randomized, Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty
A study testing iovera° in people with Arthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 8 sites in United States.
Trial summary
This study will evaluate the iovera° device in treating pain associated with total knee arthroplasty (TKA). This study will also assess if overall pain medication is reduced following TKA and will investigate the relationship between patients treated with the iovera° device and length of hospital stay, pain, patient… Read more about this study
- Who is it for?
- Ages 22 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis of the Knee
- What is being tested?
- iovera°
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2014to Jun 2016
- Phase
- Interventional
- 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 22 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 22 to 79 years of age
- Scheduled to undergo primary unilateral TKA under spinal anesthesia for primary diagnosis of osteoarthritis
- American Society of Anesthesiology (ASA) Physical Classification System classes I-III
- Anticipation of discharge to home after inpatient acute post-op phase (age, co-morbidities, home environment, and social support are in favor of discharge to home in the opinion of the Investigator)
- Subject is willing and able to give written informed consent.
- Subject is fluent in verbal and written English.
- Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
- Subject is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Subject to an unacceptable risk by study participation.
Who cannot join
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months).
- Concurrent painful physical condition, surgery, or musculoskeletal disease that requires or may require analgesic treatment during study follow-up that is not strictly related to the target knee being treated with iovera°, which have the potential to confound the postoperative assessments (e.g., significant pain from other joints, chronic neuropathic pain, concurrent or planned contralateral TKA, concurrent foot, neck, spine, hip, or other musculoskeletal disease, arthritis, or planned surgery, etc.).
- Greater than 15° malalignment (varus or valgus) on pre-operative radiograph.
- Previous myoscience FCT™ treatment.
- Previous Partial or Total Knee Arthroplasty. Partial or Total Knee Arthroplasty of the contralateral knee is permitted if [surgery was completed at least twelve (12) months prior to screening].
- Body Mass Index ≥ 40
Show all 22Show fewer
- Prior surgery in the treatment areas that may alter the anatomy of the infrapatellar branch of the saphenous nerve (ISN) or the anterior femoral cutaneous nerve (AFCN) or result in scar tissue in the treatment area.
- Any clotting disorder and/or use of an anticoagulant (e.g. warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device. Low dose aspirin (81mg or less daily) for cardiac prophylaxis allowed.
- Any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes.
- Open and/or infected wound in the treatment areas.
- Allergy to lidocaine.
- History of cryoglobulinemia
- History of paroxysmal cold hemoglobinuria.
- History of cold urticaria.
- History of Raynaud's disease.
- History of opioid or alcohol abuse.
- Subject is pregnant or planning to become pregnant while enrolled in the study.
- Current enrollment in any investigational drug or device study or participation within 30 days prior to screening.
- Currently being treated for related knee injury under worker's compensation claim or equivalent (i.e. legal case).
- Any chronic medical condition that in the Investigator's opinion would prevent adequate participation.
- Any chronic medication use (prescription, over-the-counter, etc.) that in the Investigator's opinion would affect study participation or Subject safety.
- For any reason, in the opinion of the Investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Colorado Orthopedic Consultants, P.C.
Englewood, Colorado, 80110
Holy Cross Hospital Orthopedic Research Institute
Fort Lauderdale, Florida, 33334
LSUHSC - Department of Orthopaedics
New Orleans, Louisiana, 70112
Rothman Institute
Philadelphia, Pennsylvania, 19107
University of California San Diego
San Diego, California, 92130
Phoenix Clinical Research, LLC
Tamarac, Florida, 33321
Cleveland Clinic Florida
Weston, Florida, 33331
About this study
Official title: A Post-Market, Multi-Center, Prospective, Double-Blind, Randomized, Controlled Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty
This study will evaluate the iovera° device in treating pain associated with total knee arthroplasty (TKA). This study will also assess if overall pain medication is reduced following TKA and will investigate the relationship between patients treated with the iovera° device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.
- Conditions
- Arthritis of the Knee
- Being tested
- iovera°, iovera° Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iovera°Device
Use of iovera° device to administer treatment Focused Cold Therapy
iovera° ShamDevice
iovera° device used for sham treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with focused cold therapy. Receives: Device: iovera° |
| Sham | Sham comparator | Sham treatment with focused cold therapy device Receives: Device: iovera° Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Consumption of Opioids Total Daily Morphine Equivalent (TME) (mg/Day)
The cumulative morphine equivalent was divided by the number of days to provide a Total Daily Morphine Equivalent (TME) for each Subject.
Measured: hospital discharge to 6 Weeks post-TKA surgery
Secondary outcomes (8)
Change in Pain From Baseline to Six Weeks
The Numeric Rating Scale for Pain (NRS for Pain) is a measure of pain intensity which is assessed on a scale from 0 to 10 with 0 being no pain at all and 10 being the worst pain imaginable. The Subject provides a self-reported score based on their pain in the target knee at the time the questionnaire is administered (labeled 'now' in the tables below) as well as their pain in the past 7 days (labeled "past 7" in the tables below).
Measured: Baseline to 6 Weeks
Change in WOMAC Scores at 6 Weeks After Surgery
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a tri-dimensional, disease-specific, Subject-reported outcome measure. It consists of 24 questions with 5 questions regarding pain, 2 questions regarding stiffness and 17 questions regarding function in Subjects with osteoarthritis of the hip and/or knee. Each question is answered on a scale of 0 (none)-10 (extreme). Higher scores are associated with worse outcomes.
Measured: Baseline to 6 weeks after surgery
Length of Hospital Stay
Measured: treatment to hospital discharge
Change in Active Range of Motion From Baseline to 2 Weeks After Surgery
Range of motion measures the physical function of the replaced knee during active flexion at the specified timepoints.
Measured: baseline to 2 weeks after surgery
40 Meter Walk Test
The 40 Meter Walk Test measured the average speed in meters per second a Subject could walk 40 meters.
Measured: Baseline, 2,4,6,12 weeks
30 Second Chair Test
The 30 Second Chair Test evaluates physical function during recovery by measuring the number of times a subject could go from seated in a chair to standing over the course of 30 seconds.
Measured: Baseline, 2,4,6,12 weeks after surgery
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
The 36-question survey captures the Subject's perception of their general health by sorting them into multi-item scales that assess eight health concepts rather than a single total score. The survey used ten components to assess the health concepts: Physical, Mental, Physical Functioning, Role- Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Health Transition. Subject responses to the SF-36 survey were recorded. Scores can range from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.
Measured: Baseline to Week 6
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
8 domains assessing physical, mental and social health while also covering important areas of self-reported health: pain, fatigue, depression, anxiety, sleep, and physical function. A high PROMIS domain sub-score indicates more of that concept being measured. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. The referent population is usually the US General Population. lower scores are less favorable, and higher scores are more favorable.
Measured: Baseline to 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionMay 2016
- Study completionJun 2016
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 Arthritis of the KneeStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284113
- Sponsor's protocol ID
- MYO-1070
- Status last verified
- Jan 2024
- First submitted
- 3 Nov 2014
- Last updated
- 24 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Multi-Center, Prospective, Double-Blind, Randomized, Controlled Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02284113
- Acronym / sponsor ID
- MYO-1070
- Conditions
- Arthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the iovera° device in treating pain associated with total knee arthroplasty (TKA). This study will also assess if overall pain medication is reduced following TKA and will investigate the relationship between patients treated with the iovera° device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.
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 |
|---|---|---|
| Treatment | Experimental | Device: iovera°Treatment with focused cold therapy. |
| Sham | Sham comparator | Device: iovera° ShamSham treatment with focused cold therapy device |
Who may qualify
- Ages
- 22 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 22 to 79 years of age
- Scheduled to undergo primary unilateral TKA under spinal anesthesia for primary diagnosis of osteoarthritis
- American Society of Anesthesiology (ASA) Physical Classification System classes I-III
- Anticipation of discharge to home after inpatient acute post-op phase (age, co-morbidities, home environment, and social support are in favor of discharge to home in the opinion of the Investigator)
- Subject is willing and able to give written informed consent.
Key exclusion criteria (22 listed)
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months).
- Concurrent painful physical condition, surgery, or musculoskeletal disease that requires or may require analgesic treatment during study follow-up that is not strictly related to the target knee being treated with iovera°, which have the potential to confound the postoperative assessments (e.g., significant pain from other joints, chronic neuropathic pain, concurrent or planned contralateral TKA, concurrent foot, neck, spine, hip, or other musculoskeletal disease, arthritis, or planned surgery, etc.).
- Greater than 15° malalignment (varus or valgus) on pre-operative radiograph.
- Previous myoscience FCT™ treatment.
- Previous Partial or Total Knee Arthroplasty. Partial or Total Knee Arthroplasty of the contralateral knee is permitted if [surgery was completed at least twelve (12) months prior to 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 |
|---|---|---|
| iovera°Use of iovera° device to administer treatment Focused Cold Therapy | Device | Treatment |
| iovera° Shamiovera° device used for sham treatment | Device | Sham |
Primary outcome
Cumulative Consumption of Opioids Total Daily Morphine Equivalent (TME) (mg/Day)
Time frame: hospital discharge to 6 Weeks post-TKA surgery
The cumulative morphine equivalent was divided by the number of days to provide a Total Daily Morphine Equivalent (TME) for each Subject.
8 secondary outcomes
Change in Pain From Baseline to Six Weeks
Time frame: Baseline to 6 Weeks
Change in WOMAC Scores at 6 Weeks After Surgery
Time frame: Baseline to 6 weeks after surgery
Length of Hospital Stay
Time frame: treatment to hospital discharge
Change in Active Range of Motion From Baseline to 2 Weeks After Surgery
Time frame: baseline to 2 weeks after surgery
40 Meter Walk Test
Time frame: Baseline, 2,4,6,12 weeks
30 Second Chair Test
Time frame: Baseline, 2,4,6,12 weeks after surgery
Change 36-Item Short Form Health Survey (SF-36) From Baseline to 6 Weeks
Time frame: Baseline to Week 6
Change in Patient Reported Outcomes Measurement Information System (PROMIS) From Baseline to Week 6
Time frame: Baseline to 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Arthritis of the Knee
Not yet recruiting
Study Comparing Osteoarthritis Programs
Osteoarthritis
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis
Recruiting
Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Physiotherapy
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Undenatured Type II Collagen for Knee Osteoarthritis Pain
Osteoarthritis, Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iovera° in people with Arthritis of the Knee, run by Pacira Pharmaceuticals, Inc at 8 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 8 inclusion and 22 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 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 27 Jul 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?
Cumulative Consumption of Opioids Total Daily Morphine Equivalent (TME) (mg/Day) (time frame: hospital discharge to 6 Weeks post-TKA surgery). 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 24 Jan 2024.