Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490355
• Other study ID #: STU-2022-0337
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2022
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Study Team
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Procedure:
• Radiofrequency Ablation (RFA)
RFA involves heating of periarticular nerves using continuous RFA (80-90C for 60-90 seconds) that results in electromodulation and denervation reducing pain. It can be done under fluoroscopy or CT guidance. CT guidance has additional benefit of better localization of the nerves, as opposed to simple bony landmarks used in fluoroscopy, since nerve branching variations are common and will be used in this study.
• Perineural Steroid Injection
Perineural Steroid Injections involve CT guided injection of Local Anesthetic and Steroid into a nerve root of the spine to provide ongoing pain relief.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hip Functional score at baseline (pre-procedure)	Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at baseline (pre-procedure). Possible scores range from 1-100, where lower scores indicate worse function.	Baseline (Pre-Procedure)
Primary	Hip Functional score at 2 weeks post procedure	Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 2 weeks post procedure. Possible scores range from 1-100, where lower scores indicate worse function.	2 weeks post procedure
Primary	Hip Functional score at 3 months post procedure	Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 3 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.	3 months post procedure
Primary	Hip Functional score at 6 months post procedure	Hip functional score will be assessed using current standard of care Hip score questionnaire for hip OA at 6 months post procedure. Possible scores range from 1-100, where lower scores indicate worse function.	6 months post procedure
Primary	Knee Functional score as measured by standard of care questionnaire for knee OA at baseline (pre-procedure)	Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at baseline (pre-procedure). Possible scores range from 1-100, where higher scores indicate worse function.	Baseline (pre-procedure)
Primary	Knee Functional score as measured by standard of care questionnaire for knee OA at 2 weeks post procedure	Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 2 weeks post procedure. Possible scores range from 1-100, where higher scores indicate worse function.	2 weeks post procedure
Primary	Knee Functional score as measured by standard of care questionnaire for knee OA at 3 months post procedure	Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 3 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.	3 months post procedure
Primary	Knee Functional score as measured by standard of care questionnaire for knee OA at 6 months post procedure	Knee functional score will be measured using current standard of care questionnaire for knee osteoarthritis (OA) at 6 months post procedure. Possible scores range from 1-100, where higher scores indicate worse function.	6 months post procedure