Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation

NCT03688477 | Withdrawn FDA Device

• 1 other identifier: MYO-1348
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption

  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.

  3 months

Secondary Outcomes (4)

• Numerical Rating Score (NRS) for Pain

  3 months

• International Knee Documentation Committee (IKDC) Score

  3 months

• Active Range of Motion - Extension and Flexion

  3 months

• Straight Leg Raise

  3 months

Study Arms (2)

iovera°

EXPERIMENTAL

Patients will receive iovera° prior to stand of care ACL

Device: iovera°

Standard of Care

NO INTERVENTION

Patients will receive standard of care ACL procedure without iovera° treatment.

Interventions

iovera° DEVICE

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

iovera°

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.).

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

SurgiCare of Manhattan

New York, New York, 10017, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

US (1)