Knee Arthroplasty, TotalNCT02947321
Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
A study testing Genicular Nerve RFA in people with Knee Arthroplasty, Total and Osteoarthritis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative… Read more about this study
- Who is it for?
- Ages 45 to 79 years
- Conditions the study is for
- Knee Arthroplasty, Total, Osteoarthritis, Radiologic Tibiofemoral Osteoarthritis
- What is being tested?
- Genicular Nerve RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 9 Sep 2020
- 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 45 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical candidate for total knee arthroplasty secondary to osteoarthritis
- Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)
Who cannot join
- Worst knee pain score on day of evaluation <4/10
- Already taking opioids >100 mg/day of morphine equivalent dose
- Infectious etiology (over RFA insertion site or systemic)
- Workers compensation
- History of adverse reaction to local anesthetic or contrast
- History of intraarticular injection in the last 6 weeks with steroids or hyaluronic acids
Show all 18Show fewer
- Prior total knee arthroplasty
- Prior open knee surgery or ligament reconstruction
- Prior RFA of knee joint
- Connective tissue diseases affecting the knee
- Sciatic pain
- Pacemaker
- Pregnancy
- Severe medical disease
- Serious neurological disorders
- Serious psychiatric disorders
- Suicidal or homicidal ideation
- BMI>50
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).
Read the detailed description
Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.
- Being tested
- Genicular Nerve RFA, Sham Genicular Nerve RFA
- Keywords
- Radiofrequency ablation
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular Nerve RFAProcedure or surgery
Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed.
Sham Genicular Nerve RFAProcedure or surgery
Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group.
| Study group | Role | What they receive |
|---|---|---|
| RFA Group | Experimental | A genicular nerve RFA will be performed prior to planned total knee arthroplasty. Receives: Procedure: Genicular Nerve RFA |
| Control Group | Sham comparator | A sham genicular nerve RFA will be performed prior to planned total knee arthroplasty. Receives: Procedure: Sham Genicular Nerve RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pain score at rest
Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
Measured: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Comparison of pain score with ambulation
Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
Measured: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Secondary outcomes (11)
Comparison of PROMIS physical function score
Physical function assessment using the PROMIS physical function score
Measured: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of PROMIS global health score
Global health assessment using the PROMIS global health score
Measured: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)
Outcome assessment using the Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)
Measured: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of 7-point Patient Global Impression of Change (PGIC)
Assessment of the subject's belief about the efficacy of treatment using the PGIC.
Measured: Preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of Mobility using Timed Up and Go Test (TUG)
Assessment of mobility using the TUG test
Measured: Day of genicular RFA or sham procedure, and postoperative day 1
Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D)
Screening for depression using the CES-D
Measured: Day of genicular RFA or sham procedure and at 6 weeks postoperatively
Comparison of Total opioid use in morphine equivalents
Measured: Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively
Assessment of pain location using Michigan Body Map
Measured: Day of genicular nerve RFA
Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale
Measured: Day of genicular RFA or sham procedure
Comparison of quadriceps strength
Measured: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Comparison Range of Motion - Knee
Measured: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start26 Jan 2018
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Principal investigator, Puneet Mishra, Vanderbilt University Medical Center
- Investigators
- Puneet Mishra, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947321
- Sponsor's protocol ID
- 160663
- Status last verified
- Sep 2020
- First submitted
- 25 Oct 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
PubMed 26488691Singh JA, Vessely MB, Harmsen WS, Schleck CD, Melton LJ 3rd, Kurland RL, Berry DJ. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969-2008. Mayo Clin Proc. 2010 Oct;85(10):898-904. doi: 10.4065/mcp.2010.0115. Epub 2010 Sep 7.
PubMed 20823375Lenguerrand E, Wylde V, Gooberman-Hill R, Sayers A, Brunton L, Beswick AD, Dieppe P, Blom AW. Trajectories of Pain and Function after Primary Hip and Knee Arthroplasty: The ADAPT Cohort Study. PLoS One. 2016 Feb 12;11(2):e0149306. doi: 10.1371/journal.pone.0149306. eCollection 2016.
PubMed 26871909Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Singh JA, Lewallen DG. Are outcomes after total knee arthroplasty worsening over time? A time-trends study of activity limitation and pain outcomes. BMC Musculoskelet Disord. 2014 Dec 17;15:440. doi: 10.1186/1471-2474-15-440.
PubMed 25519240Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
PubMed 22398175Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: is it really an effective procedure for all? Knee. 2007 Dec;14(6):417-23. doi: 10.1016/j.knee.2007.06.001. Epub 2007 Jun 26.
PubMed 17596949Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8.
PubMed 24201900Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
PubMed 22357571Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.
PubMed 24187375Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011 Mar;152(3):566-572. doi: 10.1016/j.pain.2010.11.023. Epub 2011 Jan 15.
PubMed 21239114Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8.
PubMed 21388906Srikandarajah S, Gilron I. Systematic review of movement-evoked pain versus pain at rest in postsurgical clinical trials and meta-analyses: a fundamental distinction requiring standardized measurement. Pain. 2011 Aug;152(8):1734-1739. doi: 10.1016/j.pain.2011.02.008. Epub 2011 Mar 12.
PubMed 21402445Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.
PubMed 20299989Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PubMed 21055873
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GREAT Knee Pain Reduction Trial, Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial
- ClinicalTrials.gov ID
- NCT02947321
- Acronym / sponsor ID
- 160663
- Keywords
- Radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 27 Oct 2016 (estimated)
- 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.
Given the benefits of genicular nerve radiofrequency ablation (RFA) in improving pain and functional status in non-surgical patients with knee osteoarthritis as well as the high prevalence of postoperative pain from total knee arthroplasty (TKA), this study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA. Patients will be randomized to one of two study arms: RFA group (genicular nerve thermal RFA) or control group (RFA needles placed in proper location without effective neurotomy).
Detailed description
Total knee arthroplasty (TKA) is a common and effective treatment for severe knee osteoarthritis. As the average age of the population increases in developed countries, the number of TKAs performed is projected to increase to 3.48 million procedures per year by 2030, a 673% increase from 2005. Although TKA is widely accepted as an efficacious form of treatment for severe knee osteoarthritis, the incidence of patient dissatisfaction and postoperative pain cannot be ignored. Genicular nerve RFA has been performed in non-surgical patients with chronic knee osteoarthritis with significant post procedure improvement in pain and functional status. This study is designed to determine the efficacy of preoperative genicular nerve RFA in improving acute and chronic postoperative pain as well as functional status in patients undergoing TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA Group | Experimental | Procedure: Genicular Nerve RFAA genicular nerve RFA will be performed prior to planned total knee arthroplasty. |
| Control Group | Sham comparator | Procedure: Sham Genicular Nerve RFAA sham genicular nerve RFA will be performed prior to planned total knee arthroplasty. |
Who may qualify
- Ages
- 45 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical candidate for total knee arthroplasty secondary to osteoarthritis
- Radiologic tibiofemoral osteoarthritis (Kellgren-Lawrence grade 2-4)
Key exclusion criteria (18 listed)
- Worst knee pain score on day of evaluation <4/10
- Already taking opioids >100 mg/day of morphine equivalent dose
- Infectious etiology (over RFA insertion site or systemic)
- Workers compensation
- History of adverse reaction to local anesthetic or contrast
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 |
|---|---|---|
| Genicular Nerve RFAUnder fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed. | Procedure or surgery | RFA Group |
| Sham Genicular Nerve RFAUnder fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group. | Procedure or surgery | Control Group |
Primary outcome
Comparison of pain score at rest
Time frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Pain score at rest using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
Comparison of pain score with ambulation
Time frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.
Pain score with ambulation using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
11 secondary outcomes
Comparison of PROMIS physical function score
Time frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of PROMIS global health score
Time frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of Knee Injury and Osteoarthritis Outcome Joint Replacement Score (KOOS JR)
Time frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of 7-point Patient Global Impression of Change (PGIC)
Time frame: Preoperatively on the day of surgery, and at week 2, 6, 24, and 52
Comparison of Mobility using Timed Up and Go Test (TUG)
Time frame: Day of genicular RFA or sham procedure, and postoperative day 1
Comparison of Depression assessment using Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Day of genicular RFA or sham procedure and at 6 weeks postoperatively
Comparison of Total opioid use in morphine equivalents
Time frame: Day of genicular RFA or sham procedure, day of surgery, post op dy 1 and 2, and at weeks 2,6 postoperatively
Assessment of pain location using Michigan Body Map
Time frame: Day of genicular nerve RFA
Assessment of pain catastrophizing using Catastrophizing General Chronic Pain (CAT) Scale
Time frame: Day of genicular RFA or sham procedure
Comparison of quadriceps strength
Time frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
Comparison Range of Motion - Knee
Time frame: Day of genicular RFA or sham procedure, and at weeks 2 and 6 postoperatively
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 5 Oct 2020.
- Background: PubMed 26488691Skou ST, Roos EM, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Rasmussen S. A Randomized, Controlled Trial of Total Knee Replacement. N Engl J Med. 2015 Oct 22;373(17):1597-606. doi: 10.1056/NEJMoa1505467.
- Background: PubMed 20823375Singh JA, Vessely MB, Harmsen WS, Schleck CD, Melton LJ 3rd, Kurland RL, Berry DJ. A population-based study of trends in the use of total hip and total knee arthroplasty, 1969-2008. Mayo Clin Proc. 2010 Oct;85(10):898-904. doi: 10.4065/mcp.2010.0115. Epub 2010 Sep 7.
- Background: PubMed 26871909Lenguerrand E, Wylde V, Gooberman-Hill R, Sayers A, Brunton L, Beswick AD, Dieppe P, Blom AW. Trajectories of Pain and Function after Primary Hip and Knee Arthroplasty: The ADAPT Cohort Study. PLoS One. 2016 Feb 12;11(2):e0149306. doi: 10.1371/journal.pone.0149306. eCollection 2016.
- Background: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Background: PubMed 25519240Singh JA, Lewallen DG. Are outcomes after total knee arthroplasty worsening over time? A time-trends study of activity limitation and pain outcomes. BMC Musculoskelet Disord. 2014 Dec 17;15:440. doi: 10.1186/1471-2474-15-440.
- Background: PubMed 22398175Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
- Background: PubMed 17596949Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: is it really an effective procedure for all? Knee. 2007 Dec;14(6):417-23. doi: 10.1016/j.knee.2007.06.001. Epub 2007 Jun 26.
- Background: PubMed 24201900Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8.
- Background: PubMed 22357571Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
- Background: PubMed 24187375Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.
- Background: PubMed 21239114Wylde V, Hewlett S, Learmonth ID, Dieppe P. Persistent pain after joint replacement: prevalence, sensory qualities, and postoperative determinants. Pain. 2011 Mar;152(3):566-572. doi: 10.1016/j.pain.2010.11.023. Epub 2011 Jan 15.
- Background: PubMed 21388906Wylde V, Rooker J, Halliday L, Blom A. Acute postoperative pain at rest after hip and knee arthroplasty: severity, sensory qualities and impact on sleep. Orthop Traumatol Surg Res. 2011 Apr;97(2):139-44. doi: 10.1016/j.otsr.2010.12.003. Epub 2011 Mar 8.
- Individual participant dataSharing planned: No
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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.
Puneet Mishra, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genicular Nerve RFA in people with Knee Arthroplasty, Total and Osteoarthritis, run by Vanderbilt University Medical Center 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 2 inclusion and 18 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 5 Oct 2020. 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. Some participants in this study may receive a placebo. 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?
Comparison of pain score at rest (time frame: On the day of genicular nerve RFA or sham procedure, preoperatively on the day of surgery, on postoperative day 1 and 2, and at week 2, 6, 24, and 52.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947321, which also lists 17 linked publications.
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 5 Oct 2020.