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Cooled Radiofrequency vs. Hyaluronic Acid to Manage Knee Pain

NCT03381248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2023-10-10

Study results available
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Summary

This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects with osteoarthritis and knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Cooled Radiofrequency Ablation (CRFA) system compared to subjects receiving Hyaluronic Acid (HA). Approximately 168 subjects will be enrolled into this study, with subjects undergoing either CRFA or HA injection in a 1:1 randomization scheme. Follow-up will be conducted for 12 months post-CRFA, with the primary endpoint being completed at month 6. Subjects randomized to the comparison (HA) group will have the option to cross-over to the neurotomy group after completing the 6-month endpoint assessment. They will be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups to determine success. Subjects who were randomized to and received COOLIEF\* as their initial treatment will have the option to add 2 additional visits at 6-month intervals, representing 18 and 24 months post initial treatment.

Conditions

  • Osteoarthritis of the Knee

Interventions

DEVICE

Cooled Radiofrequency

Delivery of energy to ablate sensory nerves via cooled radiofrequency probe.

OTHER

Hyaluronic Acid Injection

Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain.

OTHER

Crossover from Hyaluronic Acid Injection to Cooled Radiofrequency

Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain. After 6 months, qualifying subjects in this group will have the option to crossover to receive cooled radiofrequency treatment.

Sponsors & Collaborators

  • Avanos Medical

    lead OTHER

Principal Investigators

  • Antonia F Chen, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2019-02-08
Completion
2020-07-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03381248 on ClinicalTrials.gov