Clinical trial NCT05490355: Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis
Official title: Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Osteoarthritis
perineural steroid injections
radiofrequency ablation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine if radiofrequency ablation plus steroid perineural injections at the knee or hip provide longer pain relief and better function to patients than the current standard of care, perineural steroid injections alone.

This pilot study is a prospective two arm randomized trail, all participants will be recruited from the University of Texas Southwestern Medical Center (UTSW) outpatient orthopedic clinic. 40 participants (20 hip and 20 knee OA) will be enrolled into the standard of care arm (treated with steroid injections alone) and 40 participants (20 hip and 20 knee OA) will be enrolled into the investigational arm (treatment with a combination of radiofrequency ablation (RFA) plus steroid injections) for a total of 80 enrolled participants. All subjects will complete a function and pain assessment at the time of injection and three additional time points: 2 weeks, 3 months, and 6 months post injection. This study will use the same knee function questionnaire and frequency currently used in clinic per standard of care. In addition, all participant's surgical history and prior injection history will be reviewed via the Electronic Medical Record (EMR).


Eligibility criteria: Inclusion Criteria: (1 \& 2 or 3)

1. Males or females age 18 to 100 years
2. Osteoarthritis of the knee Kellgren-Lawrence grade 3-4 OR
3. Osteoarthritis of the hip Tonnis grades 2 or higher

Exclusion Criteria:

1. History of knee or hip replacement
2. History of intra-articular steroid injections within the past 6 weeks
3. Active infection

Primary outcomes:
measure: Hip Functional score at baseline (pre-procedure)
timeFrame: Baseline (Pre-Procedure)
measure: Hip Functional score at 2 weeks post procedure
timeFrame: 2 weeks post procedure
measure: Hip Functional score at 3 months post procedure
timeFrame: 3 months post procedure
measure: Hip Functional score at 6 months post procedure
timeFrame: 6 months post procedure
measure: Knee Functional score as measured by standard of care questionnaire for knee OA at baseline (pre-procedure)
timeFrame: Baseline (pre-procedure)
measure: Knee Functional score as measured by standard of care questionnaire for knee OA at 2 weeks post procedure
timeFrame: 2 weeks post procedure
measure: Knee Functional score as measured by standard of care questionnaire for knee OA at 3 months post procedure
timeFrame: 3 months post procedure
measure: Knee Functional score as measured by standard of care questionnaire for knee OA at 6 months post procedure
timeFrame: 6 months post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Avneesh Chhabra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen AF, Mullen K, Casambre F, Visvabharathy V, Brown GA. Thermal Nerve Radiofrequency Ablation for the Nonsurgical Treatment of Knee Osteoarthritis: A Systematic Literature Review. J Am Acad Orthop Surg. 2021 May 1;29(9):387-396. doi: 10.5435/JAAOS-D-20-00522.
citation: Conger A, McCormick ZL, Henrie AM. Pes Anserine Tendon Injury Resulting from Cooled Radiofrequency Ablation of the Inferior Medial Genicular Nerve. PM R. 2019 Nov;11(11):1244-1247. doi: 10.1002/pmrj.12155. Epub 2019 May 24. No abstract available.
citation: Kim SY, Le PU, Kosharskyy B, Kaye AD, Shaparin N, Downie SA. Is Genicular Nerve Radiofrequency Ablation Safe? A Literature Review and Anatomical Study. Pain Physician. 2016 Jul;19(5):E697-705.
citation: Li G, Zhang Y, Tian L, Pan J. Radiofrequency ablation reduces pain for knee osteoarthritis: A meta-analysis of randomized controlled trials. Int J Surg. 2021 Jul;91:105951. doi: 10.1016/j.ijsu.2021.105951. Epub 2021 Apr 18.
citation: Rivera F, Mariconda C, Annaratone G. Percutaneous radiofrequency denervation in patients with contraindications for total hip arthroplasty. Orthopedics. 2012 Mar 7;35(3):e302-5. doi: 10.3928/01477447-20120222-19.
citation: Chye CL, Liang CL, Lu K, Chen YW, Liliang PC. Pulsed radiofrequency treatment of articular branches of femoral and obturator nerves for chronic hip pain. Clin Interv Aging. 2015 Mar 16;10:569-74. doi: 10.2147/CIA.S79961. eCollection 2015.
citation: Bhatia A, Hoydonckx Y, Peng P, Cohen SP. Radiofrequency Procedures to Relieve Chronic Hip Pain: An Evidence-Based Narrative Review. Reg Anesth Pain Med. 2018 Jan;43(1):72-83. doi: 10.1097/AAP.0000000000000694.