Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02546336

Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation

Ultrasound-Guided Hip Joint Cooled Radiofrequency Denervation: A Prospective Pilot Study

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Women's College Hospital · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEUltrasound-Guided Cooled Radiofrequency Hip DenervationLight 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.

Timeline

Start date
2019-02-01
Primary completion
2019-02-01
Completion
2019-02-01
First posted
2015-09-10
Last updated
2019-02-27

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02546336. Inclusion in this directory is not an endorsement.