An interventional study of Cooled RFA treatment with COOLIEF* device and intra-articular corticosteroid injection in Osteoarthritis, Hip, sponsored by Brigham and Women's Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-01.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
This will be a multi-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function in subjects treated with CRFA compared with standard of care intra-articular steroid injections
This prospective, single-blinded randomized clinical trial investigates the effectiveness of using cooled radiofrequency ablation (CRFA) for the treatment of osteoarthritis (OA) hip pain and function compared with standard of care intra-articular steroid injections. This study also aims to determine if CRFA is more effective at decreasing hip pain from OA after treatment and improving hip function in terms of range of motion and walking mobility when compared to corticosteroid hip injections. The primary outcome of interest is a decrease in visual analog scale (VAS) pain as reported following treatment with either a hip injection or following RFA treatment for patients who are not candidates for total hip arthroplasty (THA). Secondary objectives include physical performance at each follow-up time point including range of motion and 50 ft walk test, Hip disability and Osteoarthritis Outcome Score (HOOS) and PROMIS questionnaires at each follow-up time point, patient satisfaction at 24 weeks after treatment, and the number of subjects requesting additional treatment for hip pain during the follow-up period.
The assessments will be conducted by comparing patients with pain from hip OA who get CRFA treatment versus patients who get a hip corticosteroid injection. The research hypothesis is that CRFA will lead to a greater reduction in pain up to 24 weeks +/- 2 weeks following treatment compared to a hip corticosteroid injection. This may result in patients having greater relief of their hip pain which may improve joint function and quality of life with the availability of a new alternative to treat hip OA.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
This study's planned enrollment of 60 is below the median of 90 across 458 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. Radiology guidance will be used to guide needle placement within the affected hip to administer lidocaine and a corticosteroid intra-articularly.
Drug: intra-articular corticosteroid injection
The hip and groin areas will be prepped and draped in the usual sterile fashion with ChloraPrep. Preprocedural vital signs will be performed and will be in the nursing chart for review. The HALYARD\* COOLIEF\* SINERGY\* Cooled Radiofrequency Probe (sterile, single use) is inserted through a COOLIEF\* SINERGY\* Introducer used with fluoroscopy guidance in the AP view to visualize the hip joint and sensory nerve areas over the acetabulum (femoral) and ischium (obturator) where the cooled radiofrequency ablation will be applied to create a focal thermal lesion to encompass and denervate the targeted nerves.
Procedure: Cooled RFA treatment with COOLIEF* device
Patients who are randomized to receive CRFA will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.
Also known as: cooled radiofrequency ablation (CRFA)
Patients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.
Also known as: steroid injection
Change in visual analog scale (VAS) pain by 1.5 points
VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time frame: up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain.
visual analog scale (VAS) pain scores at each follow-up time point
VAS Pain score is is scored using a ruler where the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Physical performance (hip range of motion)
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment
Physical performance (50 ft walk test)
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment
Hip disability and Osteoarthritis Outcome Score (HOOS)
This is a patient reported joint-specific score, which may be useful for assessing changes in hip pathology over time, with or without treatment. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population.
Time frame: 4 weeks +/- 2 weeks, 8 weeks +/- 2 weeks, 12 weeks +/- 2 weeks, and 24 weeks +/- 2 weeks following treatment, and 6 months and 1 year after the procedure
Patient satisfaction with the study treatment via Likert scale questionnaire
At the final study visit (week 24+/- 2 weeks), subjects will be asked about their satisfaction with the study treatment via a Likert scale questionnaire. Satisfaction will be measured by the following scale: Very dissatisfied (1), Somewhat dissatisfied (2), Neutral satisfaction (3), Somewhat satisfied (4), and Very satisfied (5). The minimum value will be 1 and the maxim value will be 5. Higher scores are a better outcome, while lower scores are a worse outcome.
Time frame: 24 weeks +/- 2 weeks after study treatment
Number of subjects requesting additional treatment for hip pain during the follow-up period
Time frame: 12 weeks after study treatment
Plan to share: No
Started Dec 2019 (actual). Primary completion is estimated for Dec 2021, 24 months after the start.
Of 197 non-industry interventional studies with no phase under Osteoarthritis, Hip, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 24 months is below that.
Counting every sponsor, half of 224 studies reached it within 29 months; a quarter within 14 and three quarters within 51.
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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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