ACL ReconstructionNCT03909516
Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction
A study testing iovera° in people with ACL Reconstruction, run by Pacira Pharmaceuticals, Inc.
Trial summary
To evaluate the outcomes of patients undergoing iovera° treatment of the ISN, AFCN and LFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ACL Reconstruction
- What is being tested?
- iovera°
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 May 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Scheduled to undergo unilateral anterior cruciate ligament reconstruction with patellar tendon autograft quadricep tendon autograft or hamstring tendon autograft
- In the opinion of the investigator, the subject is an active participant in recreational or competitive sports, physical activity, or other fitness regimen at the time of ACL injury and is seeking reconstruction to help return to sport or activity
- 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).
- Prior ligamentous injury and/or surgery of the operative knee (arthroscopic surgeries allowed) or relevant musculoskeletal impairment
- Prior surgery or injury in the knee or treatment areas that may have altered the anatomy of the target nerves or resulted in scar tissue in the iovera° treatment areas.
- Any pain disorder, neuro-muscular disorder, or neuropathy that in the opinion of the Investigator may confound post-operative assessments for pain or rehabilitation. Examples include but are not limited to: fibromyalgia, diabetic neuropathy, multiple sclerosis, etc.
- History of opioid or alcohol abuse within past 3 years and/or active opioid user for other medical conditions.
- Open and/or infected wound in the treatment areas or any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes.
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- History of cryoglobulinemia
- History of paroxysmal cold hemoglobinuria.
- History of cold urticaria.
- History of Raynaud's disease.
- 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., worker's compensation, history of noncompliance, drug dependency, etc.).
About this study
Official title: A Post-Market, Prospective Study to Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction
To evaluate the outcomes of patients undergoing iovera° treatment of the ISN, AFCN and LFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction
Read the detailed description
The most commonly reconstructed ligament in the knee is the anterior cruciate ligament (ACL). In 2006 a total of 134,421 ACL reconstructions were performed in the United States, representing a 37% increase in procedures since 19941. Today, most ACL reconstructions are performed on an outpatient basis. While this has led to improvements in patient satisfaction and cost, it has simultaneously resulted in more complicated postoperative pain management. Managing this pain via multi-modal strategies, including peripheral nerve blocks, in the postoperative phase has been shown to decrease opioid related side effects, decrease hospital stay, and increase time to ambulation. Nursing, hospital, and pharmacy utilization in managing PCA, continuous regional nerve blocks, and administration of oral opioid dosing are associated with higher costs of care and introduce sources for staff error. Furthermore, the idea of multi-modal pain management extends beyond the surgical procedure. Decreasing prescription opioid use during outpatient rehabilitation decreases NSAID and opioid related side effects.
Myoscience, Inc. (Fremont, CA) has developed a device - iovera° - as a novel, minimally-invasive procedure using cold to target sensory nerve tissue and provide temporary pain relief through cryoneurolysis. The iovera° device uses well-established principles of cryobiology to temporarily deactivate sensory nerves that contribute to pain. Prior studies of the iovera° device have provided evidence of effectiveness and safety for treatment of the Infrapatellar Branch of the Saphenous Nerve and another study has demonstrated that a short-term block of this nerve resulted in reduced pain following an ACL reconstruction.
In a multicenter, double-blind, sham-controlled, randomized trial sponsored by Myoscience, Inc, the iovera° device was shown to temporarily relieve pain in patients with osteoarthritis of the knee. Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (p=0.0004), Day 60 (p=0.0176), and Day 90 (p=0.0061). Patients deemed WOMAC pain responders at Day 120 continued to experience a statistically significant treatment effect at Day 150. Most expected side effects were mild in severity and resolved within 30 days. The incidence of device- or procedure-related adverse events was similar in the two treatment groups with no occurrence of serious or unanticipated adverse events.
The goal of the study described herein is to determine the safety and efficacy of the iovera° treatment for reducing the pain associated with anterior cruciate ligament (ACL) reconstruction
- Conditions
- ACL Reconstruction
- Being tested
- iovera°
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iovera°Device
The iovera° device will be prepared by the trained Anesthesiologist User Guide. If at any time the device does not perform as expected the Investigator and Anesthesiologist will follow procedures as outlined in the User Guide. Start and end time will be recorded. Once localized anesthesia of the block area is achieved, the Anesthesiolgist, or designee, will complete the iovera° treatment. Upon completion of block, The Anesthesiologist or designee will assess the treatment areas for adverse events. Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded.
Local Infiltration Analgesia - 20cc 0.5% ropivicaine only
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded. |
| Standard of Care + iovera° Treatment | Active comparator | The iovera° device will be prepared by the trained Anesthesiologist User Guide. If at any time the device does not perform as expected the Investigator and Anesthesiologist will follow procedures as outlined in the User Guide. Start and end time will be recorded.
Once localized anesthesia of the block area is achieved, the Anesthesiolgist, or designee, will complete the iovera° treatment. Upon completion of block, The Anesthesiologist or designee will assess the treatment areas for adverse events.
Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded.
Local Infiltration Analgesia - 20cc 0.5% ropivicaine only Receives: Device: iovera° |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Pain (ADP) Intensity Scores
The primary endpoint is the change from baseline to 10 days post-surgery in mean Average Daily Pain (ADP) Intensity Scores for iovera patients compared to standard of care.
Trial success is demonstrated under the primary hypothesis if the p-value corresponding to the study t-test for the effect of iovera compared to the standard of care group from baseline is less than or equal to 0.05.
Measured: Baseline to 10 days post-surgery
Pill Count
Amount of pills taken - medications to be recorded include prescription opioids. The investigator, or their designee, will then count the number of pills remaining in the bottle, record this amount and return the pills to the Subject.
Measured: Baseline to 12 Week
Secondary outcomes (3)
Area-Under-Effect (AUE) curves
Area-Under-Effect (AUE) curves of the change in ADP-intensity scores
Measured: Baseline to 12 Week
Single Assessment Numerical Evaluation (SANE) Score
The Single Assessment Numerical Evaluation (SANE) score was introduced as a tool to aid in the assessment of clinical outcomes by decreasing the burden of gathering outcomes data without limiting the meaningfulness of the data. It has been demonstrated to be a reliable reflection of knee symptoms after anterior cruciate ligament (ACL) reconstruction in both male and female subjects. The SANE score has been subjected to rigorous statistical evaluation and has proven to be a valid and responsive patient-reported outcome measure. The SANE score is determine by the subject's response to the following question:
"On a scale of 0 to 100, how would you rate your knee's function, with 100 being normal?"
Measured: Baseline to 12 Week
Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)
The KOOS JR. score consists of 7 questions from 3 subscales: Stiffness (1 question), Pain (4 questions), and Function in daily living (2 questions). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from None (0) to Extreme (4). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated. A copy of the KOOS JR. is located in Attachment 1. After completion by the Subject, the study coordinator or designee will enter the data into the CRF.
Measured: Baseline to 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 May 2019
- Primary completion1 May 2019
- Study completion1 May 2019
Why it stopped: Myoscience recently acquired - decided to redesign study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL ReconstructionStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Rivadeneyra, MD, Principal investigator, HOAG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909516
- Sponsor's protocol ID
- MYO-1378
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Prospective Study to Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT03909516
- Acronym / sponsor ID
- MYO-1378
- Conditions
- ACL Reconstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Myoscience recently acquired - decided to redesign study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 10 Apr 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.
To evaluate the outcomes of patients undergoing iovera° treatment of the ISN, AFCN and LFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction
Detailed description
The most commonly reconstructed ligament in the knee is the anterior cruciate ligament (ACL). In 2006 a total of 134,421 ACL reconstructions were performed in the United States, representing a 37% increase in procedures since 19941. Today, most ACL reconstructions are performed on an outpatient basis. While this has led to improvements in patient satisfaction and cost, it has simultaneously resulted in more complicated postoperative pain management. Managing this pain via multi-modal strategies, including peripheral nerve blocks, in the postoperative phase has been shown to decrease opioid related side effects, decrease hospital stay, and increase time to ambulation. Nursing, hospital, and pharmacy utilization in managing PCA, continuous regional nerve blocks, and administration of oral opioid dosing are associated with higher costs of care and introduce sources for staff error. Furthermore, the idea of multi-modal pain management extends beyond the surgical procedure. Decreasing prescription opioid use during outpatient rehabilitation decreases NSAID and opioid related side effects.
Myoscience, Inc. (Fremont, CA) has developed a device - iovera° - as a novel, minimally-invasive procedure using cold to target sensory nerve tissue and provide temporary pain relief through cryoneurolysis. The iovera° device uses well-established principles of cryobiology to temporarily deactivate sensory nerves that contribute to pain. Prior studies of the iovera° device have provided evidence of effectiveness and safety for treatment of the Infrapatellar Branch of the Saphenous Nerve and another study has demonstrated that a short-term block of this nerve resulted in reduced pain following an ACL reconstruction.
In a multicenter, double-blind, sham-controlled, randomized trial sponsored by Myoscience, Inc, the iovera° device was shown to temporarily relieve pain in patients with osteoarthritis of the knee. Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (p=0.0004), Day 60 (p=0.0176), and Day 90 (p=0.0061). Patients deemed WOMAC pain responders at Day 120 continued to experience a statistically significant treatment effect at Day 150. Most expected side effects were mild in severity and resolved within 30 days. The incidence of device- or procedure-related adverse events was similar in the two treatment groups with no occurrence of serious or unanticipated adverse events.
The goal of the study described herein is to determine the safety and efficacy of the iovera° treatment for reducing the pain associated with anterior cruciate ligament (ACL) reconstruction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded. |
| Standard of Care + iovera° Treatment | Active comparator | Device: iovera°The iovera° device will be prepared by the trained Anesthesiologist User Guide. If at any time the device does not perform as expected the Investigator and Anesthesiologist will follow procedures as outlined in the User Guide. Start and end time will be recorded. Once localized anesthesia of the block area is achieved, the Anesthesiolgist, or designee, will complete the iovera° treatment. Upon completion of block, The Anesthesiologist or designee will assess the treatment areas for adverse events. Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded. Local Infiltration Analgesia - 20cc 0.5% ropivicaine only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 65 years of age
- Scheduled to undergo unilateral anterior cruciate ligament reconstruction with patellar tendon autograft quadricep tendon autograft or hamstring tendon autograft
- In the opinion of the investigator, the subject is an active participant in recreational or competitive sports, physical activity, or other fitness regimen at the time of ACL injury and is seeking reconstruction to help return to sport or activity
- Subject is willing and able to give written informed consent.
- Subject is fluent in verbal and written English.
Key exclusion criteria (13 listed)
- Chronic opioid use (defined as daily or almost daily use of opioids for >3 months).
- Prior ligamentous injury and/or surgery of the operative knee (arthroscopic surgeries allowed) or relevant musculoskeletal impairment
- Prior surgery or injury in the knee or treatment areas that may have altered the anatomy of the target nerves or resulted in scar tissue in the iovera° treatment areas.
- Any pain disorder, neuro-muscular disorder, or neuropathy that in the opinion of the Investigator may confound post-operative assessments for pain or rehabilitation. Examples include but are not limited to: fibromyalgia, diabetic neuropathy, multiple sclerosis, etc.
- History of opioid or alcohol abuse within past 3 years and/or active opioid user for other medical conditions.
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°The iovera° device will be prepared by the trained Anesthesiologist User Guide. If at any time the device does not perform as expected the Investigator and Anesthesiologist will follow procedures as outlined in the User Guide. Start and end time will be recorded. Once localized anesthesia of the block area is achieved, the Anesthesiolgist, or designee, will complete the iovera° treatment. Upon completion of block, The Anesthesiologist or designee will assess the treatment areas for adverse events. Adductor Canal Block required, the formulation, or "cocktail," of medications used are to be recorded in the medical record. Start and end time will be recorded. Local Infiltration Analgesia - 20cc 0.5% ropivicaine only | Device | Standard of Care + iovera° Treatment |
Primary outcome
Average Daily Pain (ADP) Intensity Scores
Time frame: Baseline to 10 days post-surgery
The primary endpoint is the change from baseline to 10 days post-surgery in mean Average Daily Pain (ADP) Intensity Scores for iovera patients compared to standard of care. Trial success is demonstrated under the primary hypothesis if the p-value corresponding to the study t-test for the effect of iovera compared to the standard of care group from baseline is less than or equal to 0.05.
Pill Count
Time frame: Baseline to 12 Week
Amount of pills taken - medications to be recorded include prescription opioids. The investigator, or their designee, will then count the number of pills remaining in the bottle, record this amount and return the pills to the Subject.
3 secondary outcomes
Area-Under-Effect (AUE) curves
Time frame: Baseline to 12 Week
Single Assessment Numerical Evaluation (SANE) Score
Time frame: Baseline to 12 Week
Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)
Time frame: Baseline to 12 Week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No
Related trials for ACL Reconstruction
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Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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.
Adam Rivadeneyra, MD principal investigator
HOAG
Questions about this trial
What is this clinical trial studying?
A study testing iovera° in people with ACL Reconstruction, run by Pacira Pharmaceuticals, Inc.
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 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: withdrawn, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Average Daily Pain (ADP) Intensity Scores (time frame: Baseline to 10 days post-surgery). 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 10 May 2019.