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Corticosteroid
Radiofrequency Ablation + Steroids for Knee and Hip Osteoarthritis
N/A
Recruiting
Led By Avneesh Chhabra, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post procedure
Awards & highlights
Study Summary
This trial is testing whether radiofrequency ablation plus steroid injections at the knee or hip provide longer pain relief and better function than steroid injections alone.
Who is the study for?
This trial is for adults aged 18 to 100 with advanced osteoarthritis in the knee (Kellgren-Lawrence grade 3-4) or hip (Tonnis grades 2 or higher). It's not for those who've had a knee or hip replacement, recent steroid injections within the last six weeks, or have an active infection.Check my eligibility
What is being tested?
The study is testing if using radiofrequency ablation (RFA) with steroids provides better pain relief and improved function than just steroids alone in patients with severe knee and hip osteoarthritis. Participants will be randomly assigned to one of two groups and followed up at several time points after treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, possible nerve damage from RFA, allergic reactions to steroids, temporary increase in pain post-procedure, and rare risks associated with any invasive procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hip Functional score at 2 weeks post procedure
Hip Functional score at 3 months post procedure
Hip Functional score at 6 months post procedure
+5 moreSide effects data
From 2022 Phase 2 trial • 54 Patients • NCT0282175497%
Lymphocyte count decreased
89%
Anemia
86%
Aspartate aminotransferase increased
83%
Hyponatremia
78%
Hypoalbuminemia
72%
Alkaline phosphatase increased
69%
Platelet count decreased
67%
Alanine aminotransferase increased
58%
Fatigue
58%
Serum amylase increased
56%
Pain
53%
White blood cell decreased
53%
Hypophosphatemia
50%
Constipation
47%
Activated partial thromboplastin time prolonged
44%
Abdominal pain
44%
Creatinine increased
42%
Rash maculo-papular
42%
Nausea
39%
Blood bilirubin increased
36%
Hyperglycemia
36%
Pruritus
31%
Hypercalcemia
31%
Bloating
31%
Hypokalemia
31%
Fever
28%
Vomiting
28%
Edema limbs
25%
Diarrhea
25%
Hypermagnesemia
22%
Hyperkalemia
22%
Dry mouth
22%
Insomnia
22%
Cough
19%
Anorexia
19%
Hyperuricemia
19%
Dry skin
19%
Dyspnea
19%
Headache
19%
Hypomagnesemia
17%
Hypernatremia
17%
Neutrophil count decreased
17%
Back pain
14%
Dehydration
14%
Generalized muscle weakness
14%
Hypocalcemia
11%
Chills
11%
Weight loss
11%
Urinary retention
11%
Skin hyperpigmentation
11%
Abdominal distension
11%
Ascites
11%
Dizziness
11%
Dyspepsia
11%
Lipase increased
11%
Pain in extremity
11%
Skin and subcutaneous tissue disorders - Other, Itching
8%
Paresthesia
8%
Non-cardiac chest pain
8%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death
8%
Hypertension
8%
Hypothyroidism
8%
Mucositis oral
8%
Bone pain
8%
Fibrinogen decreased
6%
Respiratory failure
6%
Autoimmune disorder
6%
Acute kidney injury
6%
Infections and infestations - Other, severe acute respiratory syndrome coronavirus 2 (SARS-CoV2)
6%
CPK increased
6%
Pleural effusion
6%
Depression
6%
Encephalopathy
6%
Urinary tract infection
6%
Sore throat
6%
Blurred vision
6%
Hypotension
6%
Investigations - Other, Elevated TSH
6%
INR increased
6%
Arthralgia
6%
Colitis
6%
Flank pain
6%
Hematuria
6%
Hot flashes
6%
Hypoglycemia
6%
Sinus bradycardia
6%
Sinus tachycardia
6%
Skin infection
6%
Atrial fibrillation
6%
Confusion
3%
Lung infection
3%
Anaphylaxis
3%
Chest wall pain
3%
Infections and infestations - Other, Cellulitis - infection left upper extremity
3%
Gastritis
3%
Jejunal perforation
3%
Gastrointestinal disorders - Other, Abdominal fullness
3%
Nervous system disorders - Other, Tongue numbness
3%
Arthritis
3%
Skin and subcutaneous tissue disorders - Other, Plaque rash
3%
Hepatic hemorrhage
3%
Dysphagia
3%
Rash acneiform
3%
Respiratory, thoracic and mediastinal disorders - Other, Pulmonary abnormalities
3%
Skin and subcutaneous tissue disorders - Other, Cracked skin
3%
Skin and subcutaneous tissue disorders - Other, Dermatitis - right buttocks
3%
Depressed level of consciousness
3%
Erectile dysfunction
3%
Hyperhidrosis
3%
Pneumonitis
3%
Skin and subcutaneous tissue disorders - Other, Psoriasis; lower back
3%
Myositis
3%
Peripheral sensory neuropathy
3%
Urinary frequency
3%
Watering eyes
3%
Somnolence
3%
Cataract
3%
Glaucoma
3%
Hypoxia
3%
Musculoskeletal and connective tissue disorder - Other, Myasthenia Gravis
3%
Delirium
3%
Pelvic pain
3%
Skin and subcutaneous tissue disorders - Other, Face swelling
3%
Skin and subcutaneous tissue disorders - Other, Swelling - left leg
3%
Pneumothorax
3%
Nasal congestion
3%
Upper respiratory infection
3%
Papulopustular rash
3%
Urinary incontinence
3%
Skin and subcutaneous tissue disorders - Other, Skin discoloration
3%
Infections and infestations - Other, Tinea cruris
3%
Eye disorders - Other, Eye itching
3%
Facial nerve disorder
3%
Fall
3%
Skin and subcutaneous tissue disorders - Other, Itching arm and chest
3%
Skin and subcutaneous tissue disorders - Other, swelling- feet/legs
3%
Bullous dermatitis
3%
Stroke
3%
Acidosis
3%
Bruising
3%
Dry eye
3%
Erythema multiforme
3%
Esophageal varices hemorrhage
3%
Eye disorders - Other, Eye irritation
3%
Fracture
3%
Gastroesophageal reflux disease
3%
Gastrointestinal disorders - Other, Bloating
3%
Gastrointestinal disorders - Other, Epigastric pain
3%
General disorders and administration site conditions - Other, Numbness - left hand
3%
Hematoma
3%
Hemorrhoids
3%
Hyperthyroidism
3%
Immune system disorders - Other, Allergy development
3%
Immune system disorders - Other, Skin rash near anus/groin
3%
Infections and infestations - Other, Headaches and nose bleeds
3%
Infections and infestations - Other, Staph
3%
Infections and infestations - Other, Thrush
3%
Lethargy
3%
Localized edema
3%
Musculoskeletal and connective tissue disorder - Other, Leg cramps
3%
Myalgia
3%
Skin and subcutaneous tissue disorders - Other, Keratosis; frontal scalp
3%
Skin and subcutaneous tissue disorders - Other, Mild rash on shoulder and sparsely on back
3%
Skin and subcutaneous tissue disorders - Other, Wound to gluteal folds
3%
Skin and subcutaneous tissue disorders - Other, itching-anus
3%
Skin and subcutaneous tissue disorders - Other, swelling- ankle
3%
Skin hypopigmentation
3%
Allergic reaction
3%
Allergic rhinitis
3%
Blood and lymphatic system disorders - Other, aPTT decreased
3%
Gastrointestinal disorders - Other, Indigestion
3%
Gastroparesis
3%
Memory impairment
3%
Pharyngolaryngeal pain
3%
Skin and subcutaneous tissue disorders - Other, Abrasion on forehead
3%
Skin and subcutaneous tissue disorders - Other, Brown lesion/rash
3%
Skin and subcutaneous tissue disorders - Other, Dermatitis - penis
3%
Skin and subcutaneous tissue disorders - Other, specify
3%
Skin and subcutaneous tissue disorders - Other, Redness to radiation area
3%
Wheezing
3%
Ileal obstruction
3%
Immune system disorders - Other, Skin rash near anus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radiofrequency Ablation/Trans-arterial Catheter Chemoembolization (RFA/TACE)
Radiofrequency Ablation/Cryoablation (RFA/CA)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Perineural Steroid Injections Plus Radiofrequency AblationExperimental Treatment2 Interventions
Participants assigned to this study arm will receive Perineural Steroid Injections plus Radiofrequency Ablation per clinical standards.
Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.
Group II: Perineural Steroid Injections AloneActive Control1 Intervention
Participants assigned to this study arm will receive only Perineural Steroid Injections per clinical standards.
Participant will also complete a joint function questionnaire at 4 time points, pre-procedure, 2 weeks post procedure, 3 months post procedure, and 6 months post procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency Ablation (RFA)
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,655 Total Patients Enrolled
3 Trials studying Osteoarthritis
119 Patients Enrolled for Osteoarthritis
Avneesh Chhabra, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had steroid injections into a joint in the last 6 weeks.I have severe knee or hip arthritis.I currently have an infection.I am between 18 and 100 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Perineural Steroid Injections Alone
- Group 2: Perineural Steroid Injections Plus Radiofrequency Ablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals under the age of twenty able to take part in this research?
"Data from this trial shows that the age range of participants is between 18 and 100 years old. Separately, there are 41 trials for minors and 691 studies available to seniors."
Answered by AI
Is this research team still recruiting participants?
"The study's page on clinicaltrials.gov confirms that it is not currently recruiting patients, having first been posted November 1st and last updated September 29th 2022. However, there are 729 other medical trials actively looking for participants at this time."
Answered by AI
What specific criteria must be met to take part in this clinical experiment?
"This trial is accepting 80 individuals aged 18 to 100 who suffer from hip osteoarthritis. Other inclusion criteria include either (1 & 2 or 3) and being of either gender with a Kellgren-Lawrence grade of 3-4 for knee OA, or Tonnis grades of 2 or higher for hip OA."
Answered by AI
Who else is applying?
What state do they live in?
Arkansas
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
3+
What site did they apply to?
University of Texas Southwestern Medical Center
What questions have other patients asked about this trial?
How long does the trial take?
PatientReceived no prior treatments
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