Clinical trial NCT02546336: Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation
Official title: Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation: A Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hip Osteoarthritis
Chronic Pain
Keywords: Ultrasound Guidance
Cooled Radiofrequency
Hip Denervation
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2015-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) Score
timeFrame: 12 months
Secondary outcomes:
measure: Short Form (12) Health Survey (SF-12)
timeFrame: 12 months
measure: EQ-5D
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital/ Saint Michael's Hospital
name: Michael Gofeld, MD, FIPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
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