Clinical trial NCT05473663: Radiofrequency Ablation After Total Knee Arthroplasty
Official title: A 6-month, Double-blinded, Sham-controlled Clinical Trial Assessing the Clinical Usefulness of Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Knee Pain
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Boston University
name: Tufts Medical Center
name: Rheumatology Research Foundation
First posted: 2022-07-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess how clinically useful and safe genicular nerve radiofrequency ablation is in people with chronic pain after total knee arthroplasty performed for osteoarthritis.


Eligibility criteria: Inclusion Criteria:

1. Eligible individuals over 18 years of age in general good health apart from their chronic knee pain
2. At least one year post-TKA
3. Report of chronic knee pain classified using a standard question about the presence of "pain, aching, or stiffness in the knee on most days for at least one month during the prior 6 months"
4. In an unacceptable symptom state classified using a validated question: "Think about all consequences of your arthroplasty in the last week. If you were to remain for the rest of your life as you were during the last week, would the current state be acceptable or unacceptable for you?"
5. Willingness to complete all the study procedures, including a daily pain NRS, AE, and medication usage questions via daily notification
6. Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed

Exclusion Criteria:

1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined at 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy)
2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control as outlined in Section 5.3.1 during the study period
3. Significant evidence of infection within the knee or radiographic evidence of prosthesis loosening as defined by the orthopedic surgeon
4. Individuals with pain exclusively located in the posterior knee, evaluated systematically using a validated Knee Pain Map
5. Individuals who do not achieve a 70% pain reduction following the initial prognostic block, consistent with clinical practice
6. Participation in a clinical research trial that included the receipt of an investigational product (IP) or any experimental therapeutic procedure within 30 days prior to the Screening Visit, or planned participation in any such trial
7. Use of anticoagulants and inability to withhold for three days prior to the study RFA procedure with clearance by the prescribing physician
8. Other conditions that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation

Primary outcomes:
measure: Acceptability by actively treated participants Outcome
timeFrame: 3 months
measure: Safety Outcome
timeFrame: 6 months
measure: Efficacy Outcome
timeFrame: 3 months
Secondary outcomes:
measure: Pain Number Rating Score (NRS)
timeFrame: 6 months
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1-, 3-, and 6-month visits
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 1-, 3-, and 6-month visits
measure: Quality of Life Measured using Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS QOL)
timeFrame: 1-, 3-, and 6-month visits
measure: Quality of Life Measured using Patient Reported Outcome Measurement Information System (PROMIS) Global 10
timeFrame: 1-, 3-, and 6-month visits
measure: Walk Test
timeFrame: 1-, 3-, and 6-month visits
measure: Chair Stand Test
timeFrame: 1-, 3-, and 6-month visits
measure: Daily Step Count
timeFrame: 1-, 3-, and 6-month visits
measure: Incidence of Pain Medication use
timeFrame: 1-, 3-, and 6-month visits
measure: Gait Analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
Study officials:
affiliation: UMass Worcester (UMass Chan Medical School)
name: Timothy E McAlindon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Worcester (UMass Chan Medical School)
name: Phibi E Ngankam, BS
role: STUDY_CHAIR
References: