Evaluate the Iovera° Device in Treating Pain Associated With Anterior Cruciate Ligament Reconstruction

Launched by PACIRA PHARMACEUTICALS, INC · Apr 8, 2019

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 to 65 years of age
• • 2. Scheduled to undergo unilateral anterior cruciate ligament reconstruction with patellar tendon autograft quadricep tendon autograft or hamstring tendon autograft
• • 3. 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
• • 4. Subject is willing and able to give written informed consent.
• • 5. Subject is fluent in verbal and written English.
• • 6. Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
• • 7. 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.
• Exclusion Criteria:
• • 1. Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months).
• • 2. Prior ligamentous injury and/or surgery of the operative knee (arthroscopic surgeries allowed) or relevant musculoskeletal impairment
• • 3. 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.
• • 4. 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.
• • 5. History of opioid or alcohol abuse within past 3 years and/or active opioid user for other medical conditions.
• • 6. 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.
• • 7. History of cryoglobulinemia
• • 8. History of paroxysmal cold hemoglobinuria.
• • 9. History of cold urticaria.
• • 10. History of Raynaud's disease.
• • 11. Any chronic medical condition that in the Investigator's opinion would prevent adequate participation.
• • 12. Any chronic medication use (prescription, over-the-counter, etc.) that in the Investigator's opinion would affect study participation or Subject safety.
• • 13. 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.).