Osteoarthritis, Hip
Conditions
Brief summary
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
Detailed description
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.
Interventions
PROCEDURECooled 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.
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.
Sponsors
Rothman Institute Orthopaedics
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects older than 18 years of age presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days (Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4) 2. Relief of patients' typical hip pain symptoms after a positive diagnostic nerve block test and eligibility for cooled radiofrequency ablation of these same nerves
Exclusion criteria
1. Patients who have received any steroid injection in hip within the last 90 days 2. Individuals who cannot consent for themselves such as children and subjects with impaired decision making 3. Local infection at injection site or active systemic infection 4. Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and CRFA given proximity to major artery. (No anticoagulation contraindications for joint injection) 5. Automated implantable cardioverter defibrillator with inability to utilize magnet for CRFA per treating cardiologist 6. Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment 7. Allergy or severe renal impairment precluding iodinated contrast or magnevist injection despite standard premedication protocol 8. Negative diagnostic nerve block tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual analog scale (VAS) pain by 1.5 points | up to 24 weeks +/- 2 weeks after either a hip injection or following CRFA treatment for hip OA pain. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical performance (hip range of motion) | 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) | 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) | 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 | 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. |
| visual analog scale (VAS) pain scores at each follow-up time point | 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 | 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) |
| Patient satisfaction with the study treatment via Likert scale questionnaire | 24 weeks +/- 2 weeks after study treatment | 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. |
| Number of subjects requesting additional treatment for hip pain during the follow-up period | 12 weeks after study treatment | — |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | 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 | 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. |
Countries
United States
Contacts
Primary ContactAntonia F Chen, MD/ MBA
Outcome results
None listed