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

NCT03909516 | Withdrawn DMC FDA Device

• 1 other identifier: MYO-1378
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

ACL Reconstruction

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to 12 Week

Secondary Outcomes (3)

• Area-Under-Effect (AUE) curves

  Baseline to 12 Week

• Single Assessment Numerical Evaluation (SANE) Score

  Baseline to 12 Week

• Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.)

  Baseline to 12 Week

Study Arms (2)

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

Device: iovera°

Interventions

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

Standard of Care + iovera° Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 Officials

• Adam Rivadeneyra, MD

  HOAG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share