Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation

Not Applicable

Withdrawn

• Conditions: Chronic Pain; Hip Osteoarthritis
• Interventions: Device: Ultrasound-Guided Cooled Radiofrequency Hip Denervation

• Registration Number: NCT02546336
• Lead Sponsor: Women's College Hospital

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.

Study Timeline

• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Status Verified: 2019-02
• Study Start: 2019-02-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-02-01
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound-Guided Hip Denervation	Ultrasound-Guided Cooled Radiofrequency 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.

Primary Outcome Measures

Name	Time	Method
Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) Score	12 months	A questionnaire designed to assess pain, stiffness, and physical function in patients with hip and/or knee osteoarthritis (OA)1; The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing Stiffness (2 items): after first waking and later in the day Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.

Secondary Outcome Measures

Name	Time	Method
Short Form (12) Health Survey (SF-12)	12 months	A generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
EQ-5D	12 months	EQ-5D is a standardised instrument for use as a measure of health outcome.It is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is primarily designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete. Instructions to respondents are included in the questionnaire.

Trial Locations

Locations (1)

Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada