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Cryoneurolysis for ACL Reconstruction

N/A

Waitlist Available

Research Sponsored by Virtua Health, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients aged 14 and over

Patients undergoing autograft ACL reconstruction

Must not have

Under the age of 14

Non-English speaking/reading patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 1-week, 6-weeks, 12-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the impact of using extreme cold temperatures to target nerves in the knee before surgery in reducing pain for patients undergoing ACL reconstruction. Participants will be randomly assigned to either receive standard care or

Who is the study for?

This trial is for patients scheduled for ACL reconstruction using their own tendon. They must be able to undergo standard care and willing to potentially receive Cryoneurolysis before surgery. Specific eligibility criteria are not provided, but typically include being in good health with no conditions that would interfere with the study or recovery.

What is being tested?

The study tests if applying extreme cold (Cryoneurolysis) to nerves around the knee before ACL surgery can reduce pain after the operation. Participants will either get standard care or standard care plus Cryoneurolysis, chosen randomly, and compare their post-surgery pain medication use.

What are the potential side effects?

While specific side effects of Cryoneurolysis aren't listed here, it may include temporary numbness or discomfort at the treatment site, swelling, skin changes, and nerve damage risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 14 years old or older.

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I am having ACL reconstruction using my own tissue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 14 years old.

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I do not speak or read English.

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I have a skin condition or poor blood flow.

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I am having ACL surgery using donor tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 1-week, 6-weeks, 12-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 1-week, 6-weeks, 12-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 1-week, 6-weeks, 12-weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-operative opioid consumption

Secondary study objectives

IKDC Subjective Knee Evaluation Form

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: Usual care plus pre-operative cryoneurolysisExperimental Treatment1 Intervention

Those randomized to the intervention group (Group B) will receive a standard treatment of Cryoneurolysis to their surgical knee within 7-10 days of their scheduled surgery. Treatment nerves for the procedure will include the anterior femoral cutaneous nerve (AFCN), supra-patellar branch of the saphenous nerve (SPBSN) and infra-patellar branch of the saphenous nerve (IPBSN).

Group II: Arm A: ACL reconstruction usual careActive Control1 Intervention

On the day of surgery, all patients (Group A and Group B) will receive a multi-modal oral pre-operative cocktail and an ultrasound guided adductor canal block. Additionally, an ultrasound guided popliteal or infiltration of the tissue plane between the popliteal artery and the capsule of the knee (iPACK) block will be administered. The pre-operative oral medication cocktail and block medications are as follows: Acetaminophen 975 mg x 1, Celecoxib 400 mg PO x 1, adductor canal block with 133 mg (10 mL) liposomal bupivacaine (EXPAREL) admixed with 0.5% bupivacaine HCl 50 mg (10 mL), popliteal or iPACK nerve infiltration with 133 mg (10 mL) liposomal bupivacaine (EXPAREL) admixed with 0.5% bupivacaine HCl 50 mg (10 mL). 15 mg IV ketorolac at conclusion of the case will be administered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cryoneurolysis

2018

N/A

~240

0 / 6Eligibility criteria met