Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation

Withdrawn before enrolling · Not applicable

Conditions studied: Anterior Cruciate Ligament Reconstruction

In brief

To evaluate the outcomes of patients undergoing iovera° treatment of the ISN and AFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction

Key facts

Study ID

NCT03688477

Run by

Pacira Pharmaceuticals, Inc

People needed

0

Starts

2018-10-01

Expected to finish

2019-06-01

Last updated by the study team

2019-01-14

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 to 49 years of age
• Scheduled to undergo unilateral anterior cruciate ligament reconstruction with patellar 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 repair 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.

You may not qualify if…

• Prior ligamentous injury and/or surgery of either knee (arthroscopic surgeries allowed), contralateral ACL reconstruction, previous ACL surgery of the target knee, previous graft failure, 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.
• 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.
• 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.).

Where it is running

• SurgiCare of Manhattan — New York, New York, United States

Full record on ClinicalTrials.gov

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