Osteo Arthritis of HipNCT03647332
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
A study testing Cooled RFA treatment and Steroid Drug in people with Osteo Arthritis of Hip, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis of Hip
- What is being tested?
- Cooled RFA treatment and Steroid Drug
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days will be targeted. Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4
- Not an operative candidate as per RI joint replacement surgeon OR
- Subjects who do not desire joint replacement surgery after consultation with RI joint replacement surgeon
- Male or non-pregnant female older than 18 years of age
- willing and able to sign the IRB-approved informed consent document.
Who cannot join
- Any steroid injection in hip within 90 days
- Local infection at injection site or active systemic infection
- Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and RFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
- AICD with inability to utilize magnet for RFA per treating cardiologist
- Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
- Allergy or severe renal impairment precluding iodionated contrast or magnavist injection despite standard premedication protocol
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19107
Tiffany Morrison, 267-339-7818, tiffany.morrison@rothmaninstitute.com
About this study
This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections
- Conditions
- Osteo Arthritis of Hip
- Being tested
- Cooled RFA treatment, Steroid Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled RFA treatmentProcedure or surgery
cooled radiofrequency ablation
Steroid DrugDrug
steroid injection
| Study group | Role | What they receive |
|---|---|---|
| Cooled RFA treatment | Active comparator | Not described Receives: Procedure: Cooled RFA treatment |
| Steroid injection | Active comparator | Not described Receives: Drug: Steroid Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analog Scale
Measured: 24 weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start5 Jul 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647332
- Sponsor's protocol ID
- 2018Stolzenberg
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
- ClinicalTrials.gov ID
- NCT03647332
- Acronym / sponsor ID
- 2018Stolzenberg
- Conditions
- Osteo Arthritis of Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooled RFA treatment | Active comparator | Procedure: Cooled RFA treatment |
| Steroid injection | Active comparator | Drug: Steroid Drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days will be targeted. Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4
- Not an operative candidate as per RI joint replacement surgeon OR
- Subjects who do not desire joint replacement surgery after consultation with RI joint replacement surgeon
- Male or non-pregnant female older than 18 years of age
- willing and able to sign the IRB-approved informed consent document.
Key exclusion criteria (6 listed)
- Any steroid injection in hip within 90 days
- Local infection at injection site or active systemic infection
- Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and RFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
- AICD with inability to utilize magnet for RFA per treating cardiologist
- Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooled RFA treatmentcooled radiofrequency ablation | Procedure or surgery | Cooled RFA treatment |
| Steroid Drugsteroid injection | Drug | Steroid injection |
Primary outcome
Pain
Time frame: 24 weeks following treatment
Visual Analog Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooled RFA treatment and Steroid Drug in people with Osteo Arthritis of Hip, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 24 weeks following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.