Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03688477|
Recruitment Status : Withdrawn (Difficulty recruiting patients)
First Posted : September 28, 2018
Last Update Posted : January 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Reconstruction||Device: iovera°||Not Applicable|
The most commonly reconstructed ligament in the knee is the anterior cruciate ligament (ACL)1. 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 basis2. While this has led to improvements in patient satisfaction3 and cost4, 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 ambulation5. 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 error6,7. 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 effects8.
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 repair.9
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.10
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 and rehabilitation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Post-Market, Prospective Study to Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction and Rehabilitation|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||June 2019|
Patients will receive iovera° prior to stand of care ACL
iovera° is 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
No Intervention: Standard of Care
Patients will receive standard of care ACL procedure without iovera° treatment.
- Cumulative Opioid Consumption [ Time Frame: 3 months ]The number of opioid pills consumed over a 6 week period following TKA surgery. The amount of pills consumed is determined based on a count of remaining pills that occurs at each follow-up versus the amount dispensed to the subject.
- Numerical Rating Score (NRS) for Pain [ Time Frame: 3 months ]The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
- International Knee Documentation Committee (IKDC) Score [ Time Frame: 3 months ]The International Knee Documentation Committee (IKDC Questionnaire) is a knee-specific patient-reported outcome measure. IKDC has been subjected to rigorous statistical evaluation and has proven to be a valid and responsive patient-reported outcome measure. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.
- Active Range of Motion - Extension and Flexion [ Time Frame: 3 months ]
Movement Extension: Have the participant lie in a supine position on an examining table with the head of the table elevated to about 25 to 30 degrees. The leg measured should be extended. The participant should tighten their quadriceps muscles to actively extend their knee (push their knee into the table) three times. On the third trial, the Investigator or Designee measures the angle in degrees using the goniometer.
Movement Flexion: After the knee extension measurement is taken the bolster is removed and the participant is asked to place their foot as close as possible to their buttocks (foot on the table). After the knee flexion measurement is taken (on the third trial), the participant is told that they can extend their leg and relax. Examiner measures the angle in degrees using the goniometer.
- Straight Leg Raise [ Time Frame: 3 months ]
The straight leg raise immediately after surgery can be completed with the use of a knee brace at the investigator's discretion.
To perform this initial straight leg raise, the subject will lie supine, bend the unaffected knee, and keep the surgical knee straight. The subject will attempt to contract their quadriceps by straightening the surgical knee all the way, and slowly lift their leg up off the floor. The subject should try to lift their legs to a maximum of 12 inches, hold it in this position for one or two seconds, and then slowly lower their leg down. This exercise should be repeated until subject failure or to a maximum of 20 repetitions.
The number of repetitions will be recorded in subject source. If no repetitions are completed, the score is 0. If the subject displays an extension lag and cannot straighten their leg despite being able to raise it, the score is 0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688477
|United States, New York|
|SurgiCare of Manhattan|
|New York, New York, United States, 10017|