Osteoarthritis, KneeNCT03343808
Retrospective Study of the Results of Cooled Radiofrequency for Genicular Nerves Neurotomy in 40 Consecutive Patients With Osteoarthritis of the Knee and Painful Knee Arthroplasty
An observational study of Osteoarthritis, Knee, run by Hospital Son Espases.
Trial summary
Analyze the results of cooled radiofrequency in patients with chronic knee pain after one year of follow- up. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- cooled radiofrequency ablation of genicular nerves
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2015to 26 May 2017
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The procedure was performed to 33 patients with OA (two of them with inflammatory causes) and in 7 patients with TKA (four with revised TKA).
Who may be able to join
- Chronic knee pain (older than 3 months, with no response to physiotherapy, medication or hyaluronic acid infiltration) with a pain intensity according to VAS>7/10
- The radiological criteria were witness of OA with Kellgren-Lawrence index of 2 to 4.
- Painful TKA with no apparent cause and with a radiological image where a proper placement was observed
Who cannot join
- Infection or lymphangitis of the member
- Acute knee pain
- Corticoids or hyaluronic acid infiltration with a high molecular weight prior to the surgery
- Pregnancy
- Severe neurological or psychiatric disorders
- Patients with pacemakers
About this study
Official title: Pain Treatment With Cooled Radiofrequency in Osteoarthritis and Total Knee Arthroplasty: Case Series in Hospital Universitario de Son Espases
Analyze the results of cooled radiofrequency in patients with chronic knee pain after one year of follow- up.
Read the detailed description
The investigators performed a retrospective case-series reviewed of 40 patients who underwent cooled RF of genicular nerves. The investigators evaluated results of the survey of quality of life (SF36), knee society score (KSS) and the Visual Analogue Scale (VAS).
- Conditions
- Osteoarthritis, Knee
- Being tested
- cooled radiofrequency ablation of genicular nerves
- Keywords
- Cooled radiofrequency, chronic knee pain, knee arthroplasty, genicular nerve
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooled radiofrequency ablation of genicular nervesProcedure or surgery
Cooled RF consists of creating an injury in the nerve trough a high frequency flow. Unlike conventional RF, in cooled RF through a closed circuit where intravenous flows, we can create an injury for a longer period of time, at a lower temperature (standard RFA 90º C, cooled RFA 60º C) and within an area 8 times larger. As the lesion is spherical, and larger (about 10-12 mm in diameter), the chances of neurolysis of the nerve increase.
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success was defined as the number of subjects whose knee pain is reduced by ± 50% based on the Visual Analogue Scale (VAS).
The VAS is a 11- point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
Measured: one year after the procedure
Secondary outcomes (2)
Short Form (36) Health Survey
The SF36 values eight parameters: physical function, social function, physical role, emotional role, mental health, vitality, pain and general health. Zero is the worst conceivable health and 100 the best.
Measured: one year after the procedure
Knee Society Score (KSS)
The KSS consists of two parts. KS measures pain, range of motion, stability and alignment. FS measures the distance able to walk, the difficulty in going up or down stairs and the need for walking aids. The result is rated as excellent (80-100), good (70-79), regular (60-69) and bad (<60).
Measured: one year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start8 Jan 2015
- Primary completion26 May 2016
- Study completion26 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Collaborators
- José Andrés López Riquelme, María del Pilar Sanchís Cortés
- Responsible party
- Principal investigator, Andrés Camprodón Alberca, Hospital Son Espases
- Investigators
- Andrés Camprodón Alberca, Principal investigator, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343808
- Sponsor's protocol ID
- 1-2017
- Status last verified
- Nov 2017
- First submitted
- 13 Nov 2017
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Treatment With Cooled Radiofrequency in Osteoarthritis and Total Knee Arthroplasty: Case Series in Hospital Universitario de Son Espases
- ClinicalTrials.gov ID
- NCT03343808
- Acronym / sponsor ID
- 1-2017
- Conditions
- Osteoarthritis, Knee
- Keywords
- Cooled radiofrequency, chronic knee pain, knee arthroplasty, genicular nerve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Collaborators
- José Andrés López Riquelme, María del Pilar Sanchís Cortés
- Study start
- 8 Jan 2015 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 17 Nov 2017 (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.
Analyze the results of cooled radiofrequency in patients with chronic knee pain after one year of follow- up.
Detailed description
The investigators performed a retrospective case-series reviewed of 40 patients who underwent cooled RF of genicular nerves. The investigators evaluated results of the survey of quality of life (SF36), knee society score (KSS) and the Visual Analogue Scale (VAS).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The procedure was performed to 33 patients with OA (two of them with inflammatory causes) and in 7 patients with TKA (four with revised TKA).
Key inclusion criteria (3 listed)
- Chronic knee pain (older than 3 months, with no response to physiotherapy, medication or hyaluronic acid infiltration) with a pain intensity according to VAS>7/10
- The radiological criteria were witness of OA with Kellgren-Lawrence index of 2 to 4.
- Painful TKA with no apparent cause and with a radiological image where a proper placement was observed
Key exclusion criteria (6 listed)
- Infection or lymphangitis of the member
- Acute knee pain
- Corticoids or hyaluronic acid infiltration with a high molecular weight prior to the surgery
- Pregnancy
- Severe neurological or psychiatric disorders
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 radiofrequency ablation of genicular nervesCooled RF consists of creating an injury in the nerve trough a high frequency flow. Unlike conventional RF, in cooled RF through a closed circuit where intravenous flows, we can create an injury for a longer period of time, at a lower temperature (standard RFA 90º C, cooled RFA 60º C) and within an area 8 times larger. As the lesion is spherical, and larger (about 10-12 mm in diameter), the chances of neurolysis of the nerve increase. | Procedure or surgery | – |
Primary outcome
Treatment success was defined as the number of subjects whose knee pain is reduced by ± 50% based on the Visual Analogue Scale (VAS).
Time frame: one year after the procedure
The VAS is a 11- point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
2 secondary outcomes
Short Form (36) Health Survey
Time frame: one year after the procedure
Knee Society Score (KSS)
Time frame: one year after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Andrés Camprodón Alberca principal investigator
Hospital Son Espases
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Hospital Son Espases.
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 3 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: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success was defined as the number of subjects whose knee pain is reduced by ± 50% based on the Visual Analogue Scale (VAS). (time frame: one year after the procedure). 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 20 Nov 2017.