Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation

NCT ID: NCT02546336

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-02-01

Brief Summary

Hip osteoarthritis (HOA) is a common cause of pain and disability in aging population. Conservative treatment is based on lifestyle modifications, physical therapy, analgesic and anti-inflammatory medications and intra articular injections. This Prospective Pilot Study aims at investigating the efficacy of Ultrasound-Guided Cooled Radiofrequency Hip Denervation as a treatment offered to patients with HOA.

Detailed Description

Radiological prevalence of HOA is very high. Hip denervation (HD) is a known palliative procedure that was initially performed as an open surgery. The role of the obturator, femoral and sciatic nerves in hip joint innervation was discovered. Several small clinical and anatomical studies addressed feasibility and benefits of the radiofrequency hip denervation (RFHD). Ultrasound guidance may eliminate equivocality of previously published techniques and provide precise image guidance as it a is logical and anatomically sound approach when procedural targets include soft tissue, such as nerves, tendons and joint capsule. None of these structures can be localized under routine fluoroscopy. Ultrasound is a bedside imaging tool that has been accepted as safe and reliable. In two meta-analyses, the use of real-time two-dimensional ultrasound for the placement of CVCs substantially decreased mechanical complications and reduced the number of attempts at required cannulation and failed attempts at cannulation compared with the standard landmark placement. Pertinent to the proposed study, recent systematic review and meta-analysis of the accuracy of US-guided versus landmark-guided hip joint injections revealed that US-guided injections are significantly more accurate than those that are landmark-guided. The significance of this study lies in its potential to improve functional activity and pain control in patients with HOA. Also, it may eventually lead to a decrease in patients resorting to Total Hip Arthroplasty (THA) as an ultimate end solution for HOA.

Conditions

Hip Osteoarthritis; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound-Guided Hip Denervation

This is a pilot study. 15 Hip Osteoarthritis patients with chronic pain will be recruited in this pilot arm. These will undergo Ultrasound-Guided Cooled Radiofrequency Hip Denervation as intervention.

Group Type: EXPERIMENTAL

Ultrasound-Guided Cooled Radiofrequency Hip Denervation

Intervention Type: DEVICE

Light neuroleptic anesthesia and skin preparation will be performed. Under Ultrasound guidance, an active probe will be inserted. Sensory and motor stimulation will be administered. Anteroposterior fluoroscopy image will be recorded. Lesioning of articular branches of femoral and obturator nerves via radiofrequency will be performed after lidocaine injection. WOMAC, EQ-5D and SF-12 questionnaires will be used for measuring outcomes postoperatively.

Interventions

Ultrasound-Guided Cooled Radiofrequency Hip Denervation

Light neuroleptic anesthesia and skin preparation will be performed. Under Ultrasound guidance, an active probe will be inserted. Sensory and motor stimulation will be administered. Anteroposterior fluoroscopy image will be recorded. Lesioning of articular branches of femoral and obturator nerves via radiofrequency will be performed after lidocaine injection. WOMAC, EQ-5D and SF-12 questionnaires will be used for measuring outcomes postoperatively.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Primary degenerative osteoarthritis of hip joint
• Pain pre-intervention qualified as at least moderate with functional limitation moderate/severe.
• Radiological confirmation of hip osteoarthritis
• Failure of conservative therapy to control symptoms, defined as the persistence of at least moderate with functional limitation moderate/severe pain that has been refractory to prescribed medications, and other modalities, such as physical therapy and intraarticular injections. Intolerable side effects of medications and contraindications to specific methods will be also considered as a failure of the conservative therapy.
• Positive articular branches analgesic block, defined as >50% improvement in pain and function for at least 2 hours

Exclusion Criteria

• Non-English speakers
• Daily dose of opioids more than 90 MEQ
• Body Mass Index (BMI) > 30
• Uncorrectable coagulopathy
• Local and systemic infection
• Inability to obtain ultrasound image of ventral acetabulum
• Documented prior Anaphylactic Reaction to Contrast Agent
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Gofeld, MD, FIPP

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital/ Saint Michael's Hospital

Locations

Women's College Hospital

Toronto, Ontario, Canada

Countries

Canada

References

Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176.

Reference Type: BACKGROUND

PMID: 18163497 (View on PubMed)

Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Nelson AE, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of hip symptoms and radiographic and symptomatic hip osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2009 Apr;36(4):809-15. doi: 10.3899/jrheum.080677. Epub 2009 Mar 13.

Reference Type: BACKGROUND

PMID: 19286855 (View on PubMed)

Vincent HK, Heywood K, Connelly J, Hurley RW. Obesity and weight loss in the treatment and prevention of osteoarthritis. PM R. 2012 May;4(5 Suppl):S59-67. doi: 10.1016/j.pmrj.2012.01.005.

Reference Type: BACKGROUND

PMID: 22632704 (View on PubMed)

Brakke R, Singh J, Sullivan W. Physical therapy in persons with osteoarthritis. PM R. 2012 May;4(5 Suppl):S53-8. doi: 10.1016/j.pmrj.2012.02.017.

Reference Type: BACKGROUND

PMID: 22632703 (View on PubMed)

MULDER JD. Denervation of the hip joint in osteoarthritis. J Bone Joint Surg Br. 1948 Aug;30B(3):446-8. No abstract available.

Reference Type: BACKGROUND

PMID: 18877978 (View on PubMed)

Akatov OV, Dreval ON. Percutaneous radiofrequency destruction of the obturator nerve for treatment of pain caused by coxarthrosis. Stereotact Funct Neurosurg. 1997;69(1-4 Pt 2):278-80. doi: 10.1159/000099888.

Reference Type: BACKGROUND

PMID: 9711767 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22385437 (View on PubMed)

Kawaguchi M, Hashizume K, Iwata T, Furuya H. Percutaneous radiofrequency lesioning of sensory branches of the obturator and femoral nerves for the treatment of hip joint pain. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):576-81. doi: 10.1053/rapm.2001.26679.

Reference Type: BACKGROUND

PMID: 11707799 (View on PubMed)

Malik A, Simopolous T, Elkersh M, Aner M, Bajwa ZH. Percutaneous radiofrequency lesioning of sensory branches of the obturator and femoral nerves for the treatment of non-operable hip pain. Pain Physician. 2003 Oct;6(4):499-502.

Reference Type: BACKGROUND

PMID: 16871303 (View on PubMed)

Fukui S, Nosaka S. Successful relief of hip joint pain by percutaneous radiofrequency nerve thermocoagulation in a patient with contraindications for hip arthroplasty. J Anesth. 2001;15(3):173-5. doi: 10.1007/s005400170023. No abstract available.

Reference Type: BACKGROUND

PMID: 14566519 (View on PubMed)

Hoeber S, Aly AR, Ashworth N, Rajasekaran S. Ultrasound-guided hip joint injections are more accurate than landmark-guided injections: a systematic review and meta-analysis. Br J Sports Med. 2016 Apr;50(7):392-6. doi: 10.1136/bjsports-2014-094570. Epub 2015 Jun 10.

Reference Type: BACKGROUND

PMID: 26062955 (View on PubMed)

Gupta G, Radhakrishna M, Etheridge P, Besemann M, Finlayson RJ. Radiofrequency denervation of the hip joint for pain management: case report and literature review. US Army Med Dep J. 2014 Apr-Jun:41-51.

Reference Type: BACKGROUND

PMID: 24706242 (View on PubMed)

Chaiban G, Paradis T, Atallah J. Use of ultrasound and fluoroscopy guidance in percutaneous radiofrequency lesioning of the sensory branches of the femoral and obturator nerves. Pain Pract. 2014 Apr;14(4):343-5. doi: 10.1111/papr.12069. Epub 2013 May 9.

Reference Type: BACKGROUND

PMID: 23656575 (View on PubMed)

Other Identifiers

HIP RFD

Identifier Type: -

Identifier Source: org_study_id