Knee OsteoarthritisSAVE-KNEENCT07835672
Selective Nerve Ablation for Chronic Knee Pain: A Retrospective Study
An observational study of Knee Osteoarthritis and Chronic Knee Pain, run by Michał Bartoszewicz at 1 site in Poland.
Trial summary
SAVE-KNEE is a single-center retrospective observational cohort study evaluating outcomes of ultrasound-guided cryoneurolysis, radiofrequency ablation and chemical neurolysis for chronic knee pain in routine clinical care. The study uses existing clinical records from June 1, 2022 through May 14, 2026. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Chronic Knee Pain
- What is being tested?
- Ultrasound-Guided Cryoneurolysis, Ultrasound-Guided Radiofrequency Ablation and Ultrasound-Guided Chemical Neurolysis
- Type of treatment
- Surgery or procedure
- How many people
- 746 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2022to 14 May 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic knee pain treated in routine outpatient care at Reh-Medica Rehabilitation Center in Warsaw, Poland, during June 1, 2022 through May 14, 2026, identified retrospectively from electronic and paper medical records. The population includes patients with symptomatic knee osteoarthritis and patients with persistent pain after total knee arthroplasty who underwent ultrasound-guided cryoneurolysis, radiofrequency ablation or chemical neurolysis. This closed retrospective analysis includes only treatment and follow-up observations from June 1, 2022 through May 14, 2026. Later clinical observations are excluded. No treatment is assigned for research purposes.
Who may be able to join
- Age 40 years or older at the time of the procedure.
- Documented chronic knee pain lasting more than 6 months.
- Baseline pain intensity of at least 4 points on the 0-10 NRS.
- Failure of at least 6 months of conservative treatment, including medication, physiotherapy or previous intra-articular injections.
- Positive response to a targeted diagnostic genicular nerve block, if performed according to routine center practice, defined as at least 50% pain reduction during the action of the local anesthetic.
- Receipt of routine ultrasound-guided cryoneurolysis, radiofrequency ablation or chemical neurolysis of sensory nerves around the knee.
- Advanced knee osteoarthritis, usually Kellgren-Lawrence grade III-IV, in a patient unsuitable for surgery because of comorbidities or declining arthroplasty; or persistent pain after total knee arthroplasty after exclusion of infection, implant loosening, mechanical failure and joint instability.
- Index treatment between June 1, 2022 and May 14, 2026, with records documenting pretreatment baseline pain and at least one post-procedure follow-up pain assessment performed on or before May 14, 2026. Availability of WOMAC data determines inclusion in the functional-outcome analyses and is not required for the broader pain-outcome cohort.
Who cannot join
- Pregnancy.
- Active infection at the procedure site or advanced skin ulceration around the knee.
- Insufficient documentation to establish baseline pain or absence of any post-procedure follow-up assessment on or before May 14, 2026.
- Confirmed mechanical implant complications, including loosening or structural failure, or acute joint infection in patients after total knee arthroplasty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Center Retrospective Evaluation of the Effectiveness and Safety of Selective Neurolysis of Nerves Around the Knee and Selected Minimally Invasive Methods in the Treatment of Chronic Knee Pain Syndromes: Analysis of 1000 Cases
SAVE-KNEE is a single-center retrospective observational cohort study evaluating outcomes of ultrasound-guided cryoneurolysis, radiofrequency ablation and chemical neurolysis for chronic knee pain in routine clinical care.
The study uses existing clinical records from June 1, 2022 through May 14, 2026. May 14, 2026 is the fixed cutoff for both eligible treatment and follow-up observations. Later clinical observations are excluded from this analysis.
Read more
The primary outcomes are changes from the pretreatment baseline in patient-reported 0-10 numeric rating scale (NRS) knee pain and WOMAC scores at available 1-, 6- and 12-month assessments before the cutoff. Secondary outcomes include pain response, documented adverse events and repeat procedures. Follow-up availability varies; a 12-month assessment is not required for inclusion.
Treatment and follow-up were provided as routine clinical care funded by the Polish National Health Fund (NFZ), independently of this study. No treatment or additional visit is assigned for research purposes. Pain assessments were conducted in person or by telephone. When verbal assistance was needed, the final 0-10 rating was stated or confirmed by the patient.
Read the detailed description
SAVE-KNEE is a retrospective observational cohort study of existing routine clinical records at a single musculoskeletal rehabilitation center in Warsaw, Poland.
The study evaluates patients with chronic knee pain treated with minimally invasive procedures targeting sensory nerves around the knee. The principal procedures evaluated include ultrasound-guided cryoneurolysis, radiofrequency ablation, and chemical neurolysis. Selected patients may also have received adjunctive treatments, including hyaluronic acid, collagen, prolotherapy, or corticosteroid injections as part of routine clinical care.
Clinical effectiveness is evaluated using changes in patient-reported 0-10 NRS knee pain scores and WOMAC scores from baseline to available follow-up assessments at approximately 1, 6, and 12 months. Safety is assessed from procedure-related adverse events and complications documented in the available clinical records. Minor bruising at needle-entry sites was not systematically recorded; its incidence cannot be reliably quantified from these records.
Additional analyses are intended to evaluate durability of response and clinical factors potentially associated with treatment outcomes, including patient characteristics, severity of knee osteoarthritis, previous knee arthroplasty, treatment method, and adjunctive therapies.
Time perspective: Retrospective. This is a closed analysis of routine clinical records from June 1, 2022 through May 14, 2026. Both index treatment and included follow-up observations must fall within this period. Clinical observations after May 14, 2026 are excluded, even when they concern earlier treatment. Routine care may continue independently, but no future follow-up data will be added to this analysis. Treatment and follow-up were provided through the Polish National Health Fund (NFZ). No treatment or additional visit is assigned for research purposes.
Pain assessment: Patients reported pain on a 0-10 numeric rating scale (NRS), including direct ratings at qualification and on the procedure day. The baseline pain score used for outcome comparisons is the rating obtained on the procedure day before treatment. When a patient had difficulty selecting a number at follow-up, verbal assistance included questions about pain severity, percentage or fractional improvement, and confirmation of a proposed numerical value. In every case, the final recorded 0-10 score was stated or verbally confirmed by the patient; it was not assigned solely by the clinician. The use and extent of assistance cannot be identified for individual observations in the available records.
Routine follow-up at approximately 1, 6 and 12 months was conducted in person or by telephone, with a transition toward remote follow-up during the observation period. Patients reporting less than 50% improvement, adverse events or concerning symptoms were referred for in-person assessment. Follow-up mode therefore depended partly on clinical response and symptoms.
Safety documentation: Concerning symptoms reported during routine follow-up were recorded with their nature and extent. Absence of complications was not explicitly recorded. Safety analyses therefore describe documented events; no event entry is not equivalent to a confirmed event-free assessment.
Unit of observation: Enrollment refers to 746 individual participants. The approximately 1000 cases in the study title refer to treated knees rather than 1000 different people; some participants had both knees treated. Knee-level outcomes must account for the dependence of observations within a participant. Repeat procedures on the same knee are distinguished from contralateral treatment and analyzed separately from first procedures.
During in-person pain assessments, patients used a visible 0-10 numerical scale with facial illustrations as an aid. Telephone assessments used verbal numerical ratings. These measurements are described as NRS rather than a continuous visual analogue scale.
Ethics review: The Bioethics Committee at the Regional Medical Chamber in Warsaw reviewed the project under reference KB/1844/26 and determined that the retrospective analysis was non-experimental and outside its remit; it therefore declined to issue an opinion. This determination is the basis for the Not required review status.
Observation cutoff: May 14, 2026. Outcomes at approximately 1, 6 and 12 months are analyzed only when the relevant assessment occurred on or before this cutoff. Later observations are excluded. Patients with shorter available follow-up are not assumed to have completed 12 months. The number of available observations and missing measurements will be reported separately at each time point. The cutoff is an administrative boundary for this retrospective dataset and is not the date of an ethics decision.
- Conditions
- Knee Osteoarthritis, Chronic Knee Pain
- Being tested
- Ultrasound-Guided Cryoneurolysis, Ultrasound-Guided Radiofrequency Ablation, Ultrasound-Guided Chemical Neurolysis
- Keywords
- Cryoneurolysis, Radiofrequency Ablation, Chemical Neurolysis, Genicular Nerves, Ultrasound-Guided Neurolysis, WOMAC, Age-Associated Disease, Functional Decline, Numeric Rating Scale
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided CryoneurolysisProcedure or surgery
Percutaneous ultrasound-guided cryoneurolysis targeting sensory nerves around the knee, performed as part of routine clinical care for chronic knee pain. The procedure uses controlled local cooling to produce temporary interruption of sensory nerve conduction. This observational study evaluates treatment documented in routine clinical records; no procedure is assigned for research purposes.
Ultrasound-Guided Radiofrequency AblationProcedure or surgery
Percutaneous ultrasound-guided radiofrequency ablation targeting sensory nerves around the knee, performed as part of routine clinical care for chronic knee pain. Radiofrequency energy is used to produce controlled thermal neurolysis of the targeted nerve. This observational study evaluates treatment documented in routine clinical records; no procedure is assigned for research purposes.
Ultrasound-Guided Chemical NeurolysisProcedure or surgery
Percutaneous ultrasound-guided chemical neurolysis targeting sensory nerves around the knee, performed as part of routine clinical care for chronic knee pain. A neurolytic agent is administered locally to interrupt nociceptive nerve transmission. This observational study evaluates treatment documented in routine clinical records; no procedure is assigned for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| SAVE-KNEE Retrospective Cohort | Patients with chronic knee pain who underwent qualifying ultrasound-guided cryoneurolysis, radiofrequency ablation or chemical neurolysis of sensory nerves around the knee during routine care from June 1, 2022 through May 14, 2026. This closed retrospective cohort includes only clinical observations recorded for care provided on or before May 14, 2026, with baseline pain and at least one follow-up pain assessment within this period. Enrollment counts individual participants. Knee-level outcomes distinguish bilateral treatment and repeat procedures on the same knee. No treatment is assigned by the study. Receives: Procedure: Ultrasound-Guided Cryoneurolysis; Procedure: Ultrasound-Guided Radiofrequency Ablation; Procedure: Ultrasound-Guided Chemical Neurolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in patient-reported knee pain on a 0-10 numeric rating scale (NRS)
Change from baseline in patient-reported knee pain on a 0-10 NRS at 1, 6 and 12 months. Higher scores indicate greater pain; a decrease indicates improvement. Assessments were conducted in person or by telephone. When patients had difficulty selecting a number, verbal assistance included questions about pain severity, percentage or fractional improvement, and confirmation of a proposed numerical value. The final recorded 0-10 value was always stated or verbally confirmed by the patient, rather than assigned solely by the clinician. The use and extent of assistance cannot be determined for individual observations from the available records. Baseline is the patient-reported pain rating obtained on the day of the procedure, before it was performed.
Measured: Pretreatment baseline; 1 month (+/-7 days), 6 months (+/-14 days), and 12 months (+/-30 days) after the procedure; only assessments performed on or before May 14, 2026
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Change in WOMAC total score from baseline to available assessments at 1, 6 and 12 months. The full questionnaire contains 24 items scored 0 (none) to 4 (extreme): 5 pain, 2 stiffness and 17 physical-function items. Total scores range from 0 to 96; higher scores indicate worse symptoms and function, and a decrease indicates improvement. During in-person visits, patients completed the questionnaire themselves. During telephone follow-up, an assistant read all 24 questions sequentially, entered the patient's responses into an interactive worksheet, and the worksheet calculated the total score. Analyses use raw total scores in participants with the required baseline and follow-up WOMAC data.
Measured: Pretreatment baseline; 1 month (+/-7 days), 6 months (+/-14 days), and 12 months (+/-30 days) after the procedure; only assessments performed on or before May 14, 2026
Secondary outcomes (3)
Number and proportion of treated knees with documented procedure-related adverse events or complications
Number of treated knees with at least one documented procedure-related adverse event or complication, with the proportion among knees included in the record review and summaries by procedure type. Routine follow-up included open-ended questions about well-being, knee symptoms and concerns. Clinically concerning symptoms were documented with their nature and extent and prompted assessment. Minor bruising at needle-entry sites was not systematically recorded, so its incidence is not estimated. Absence of complications was not explicitly recorded; no event entry means no documented event, not confirmed absence of an event. Follow-up availability is reported with the findings. Repeat procedures are distinguished from first procedures.
Measured: From the procedure until the earliest of 12 months after treatment, the last available follow-up, or May 14, 2026
Proportion of treated knees with at least 50% reduction in knee pain intensity
Proportion of treated knees with at least 50% reduction in the recorded 0-10 NRS pain score from the procedure-day pretreatment baseline at each follow-up. Percentage reduction is 100 times (baseline score minus follow-up score) divided by baseline score. The denominator at each time point comprises knees with available baseline and corresponding follow-up scores. The final numerical rating was stated or verbally confirmed by the patient, with verbal assistance when needed. The records do not identify which ratings required assistance. Analyses account for two knees belonging to the same participant.
Measured: Pretreatment baseline; 1 month (+/-7 days), 6 months (+/-14 days), and 12 months (+/-30 days) after the procedure; only assessments performed on or before May 14, 2026
Number and proportion of treated knees undergoing a repeat pain-relieving procedure
Number of treated knees with at least one documented repeat pain-relieving procedure on the same knee during follow-up, and their proportion among knees included in the record review. Repeat procedures are identified from routine clinical records and distinguished from treatment of the contralateral knee. The initial procedure is the index procedure for each knee. Follow-up availability is reported with the findings; absence of a documented repeat procedure does not establish complete event-free follow-up.
Measured: From the index procedure until the earliest of 12 months after treatment, the last available follow-up, or May 14, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jun 2022
- Primary completion14 May 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 746 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michał Bartoszewicz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michał Bartoszewicz, Michał Bartoszewicz praktyka specjalistyczna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835672
- Sponsor's protocol ID
- SAVE-KNEE-001
- Acronym
- SAVE-KNEE
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center Retrospective Evaluation of the Effectiveness and Safety of Selective Neurolysis of Nerves Around the Knee and Selected Minimally Invasive Methods in the Treatment of Chronic Knee Pain Syndromes: Analysis of 1000 Cases
- ClinicalTrials.gov ID
- NCT07835672
- Acronym / sponsor ID
- SAVE-KNEE / SAVE-KNEE-001
- Conditions
- Knee Osteoarthritis, Chronic Knee Pain
- Keywords
- Cryoneurolysis, Radiofrequency Ablation, Chemical Neurolysis, Genicular Nerves, Ultrasound-Guided Neurolysis, WOMAC, Age-Associated Disease, Functional Decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 746 participants (actual)
- Lead sponsor
- Michał BartoszewiczUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 23 Sep 2026 (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.
SAVE-KNEE is a single-center retrospective observational cohort study evaluating outcomes of ultrasound-guided cryoneurolysis, radiofrequency ablation and chemical neurolysis for chronic knee pain in routine clinical care.
The study uses existing clinical records from June 1, 2022 through May 14, 2026. May 14, 2026 is the fixed cutoff for both eligible treatment and follow-up observations. Later clinical observations are excluded from this analysis.
The primary outcomes are changes from the pretreatment baseline in patient-reported 0-10 numeric rating scale (NRS) knee pain and WOMAC scores at available 1-, 6- and 12-month assessments before the cutoff. Secondary outcomes include pain response, documented adverse events and repeat procedures. Follow-up availability varies; a 12-month assessment is not required for inclusion.
Treatment and follow-up were provided as routine clinical care funded by the Polish National Health Fund (NFZ), independently of this study. No treatment or additional visit is assigned for research purposes. Pain assessments were conducted in person or by telephone. When verbal assistance was needed, the final 0-10 rating was stated or confirmed by the patient.
Detailed description
SAVE-KNEE is a retrospective observational cohort study of existing routine clinical records at a single musculoskeletal rehabilitation center in Warsaw, Poland.
The study evaluates patients with chronic knee pain treated with minimally invasive procedures targeting sensory nerves around the knee. The principal procedures evaluated include ultrasound-guided cryoneurolysis, radiofrequency ablation, and chemical neurolysis. Selected patients may also have received adjunctive treatments, including hyaluronic acid, collagen, prolotherapy, or corticosteroid injections as part of routine clinical care.
Clinical effectiveness is evaluated using changes in patient-reported 0-10 NRS knee pain scores and WOMAC scores from baseline to available follow-up assessments at approximately 1, 6, and 12 months. Safety is assessed from procedure-related adverse events and complications documented in the available clinical records. Minor bruising at needle-entry sites was not systematically recorded; its incidence cannot be reliably quantified from these records.
Additional analyses are intended to evaluate durability of response and clinical factors potentially associated with treatment outcomes, including patient characteristics, severity of knee osteoarthritis, previous knee arthroplasty, treatment method, and adjunctive therapies.
Time perspective: Retrospective. This is a closed analysis of routine clinical records from June 1, 2022 through May 14, 2026. Both index treatment and included follow-up observations must fall within this period. Clinical observations after May 14, 2026 are excluded, even when they concern earlier treatment. Routine care may continue independently, but no future follow-up data will be added to this analysis. Treatment and follow-up were provided through the Polish National Health Fund (NFZ). No treatment or additional visit is assigned for research purposes.
Pain assessment: Patients reported pain on a 0-10 numeric rating scale (NRS), including direct ratings at qualification and on the procedure day. The baseline pain score used for outcome comparisons is the rating obtained on the procedure day before treatment. When a patient had difficulty selecting a number at follow-up, verbal assistance included questions about pain severity, percentage or fractional improvement, and confirmation of a proposed numerical value. In every case, the final recorded 0-10 score was stated or verbally confirmed by the patient; it was not assigned solely by the clinician. The use and extent of assistance cannot be identified for individual observations in the available records.
Routine follow-up at approximately 1, 6 and 12 months was conducted in person or by telephone, with a transition toward remote follow-up during the observation period. Patients reporting less than 50% improvement, adverse events or concerning symptoms were referred for in-person assessment. Follow-up mode therefore depended partly on clinical response and symptoms.
Safety documentation: Concerning symptoms reported during routine follow-up were recorded with their nature and extent. Absence of complications was not explicitly recorded. Safety analyses therefore describe documented events; no event entry is not equivalent to a confirmed event-free assessment.
Unit of observation: Enrollment refers to 746 individual participants. The approximately 1000 cases in the study title refer to treated knees rather than 1000 different people; some participants had both knees treated. Knee-level outcomes must account for the dependence of observations within a participant. Repeat procedures on the same knee are distinguished from contralateral treatment and analyzed separately from first procedures.
During in-person pain assessments, patients used a visible 0-10 numerical scale with facial illustrations as an aid. Telephone assessments used verbal numerical ratings. These measurements are described as NRS rather than a continuous visual analogue scale.
Ethics review: The Bioethics Committee at the Regional Medical Chamber in Warsaw reviewed the project under reference KB/1844/26 and determined that the retrospective analysis was non-experimental and outside its remit; it therefore declined to issue an opinion. This determination is the basis for the Not required review status.
Observation cutoff: May 14, 2026. Outcomes at approximately 1, 6 and 12 months are analyzed only when the relevant assessment occurred on or before this cutoff. Later observations are excluded. Patients with shorter available follow-up are not assumed to have completed 12 months. The number of available observations and missing measurements will be reported separately at each time point. The cutoff is an administrative boundary for this retrospective dataset and is not the date of an ethics decision.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAVE-KNEE Retrospective Cohort | – | Procedure: Ultrasound-Guided Cryoneurolysis, Procedure: Ultrasound-Guided Radiofrequency Ablation, Procedure: Ultrasound-Guided Chemical NeurolysisPatients with chronic knee pain who underwent qualifying ultrasound-guided cryoneurolysis, radiofrequency ablation or chemical neurolysis of sensory nerves around the knee during routine care from June 1, 2022 through May 14, 2026. This closed retrospective cohort includes only clinical observations recorded for care provided on or before May 14, 2026, with baseline pain and at least one follow-up pain assessment within this period. Enrollment counts individual participants. Knee-level outcomes distinguish bilateral treatment and repeat procedures on the same knee. No treatment is assigned by the study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic knee pain treated in routine outpatient care at Reh-Medica Rehabilitation Center in Warsaw, Poland, during June 1, 2022 through May 14, 2026, identified retrospectively from electronic and paper medical records. The population includes patients with symptomatic knee osteoarthritis and patients with persistent pain after total knee arthroplasty who underwent ultrasound-guided cryoneurolysis, radiofrequency ablation or chemical neurolysis. This closed retrospective analysis includes only treatment and follow-up observations from June 1, 2022 through May 14, 2026. Later clinical observations are excluded. No treatment is assigned for research purposes.
Key inclusion criteria (8 listed)
- Age 40 years or older at the time of the procedure.
- Documented chronic knee pain lasting more than 6 months.
- Baseline pain intensity of at least 4 points on the 0-10 NRS.
- Failure of at least 6 months of conservative treatment, including medication, physiotherapy or previous intra-articular injections.
- Positive response to a targeted diagnostic genicular nerve block, if performed according to routine center practice, defined as at least 50% pain reduction during the action of the local anesthetic.
Key exclusion criteria (4 listed)
- Pregnancy.
- Active infection at the procedure site or advanced skin ulceration around the knee.
- Insufficient documentation to establish baseline pain or absence of any post-procedure follow-up assessment on or before May 14, 2026.
- Confirmed mechanical implant complications, including loosening or structural failure, or acute joint infection in patients after total knee arthroplasty.
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 |
|---|---|---|
| Ultrasound-Guided CryoneurolysisPercutaneous ultrasound-guided cryoneurolysis targeting sensory nerves around the knee, performed as part of routine clinical care for chronic knee pain. The procedure uses controlled local cooling to produce temporary interruption of sensory nerve conduction. This observational study evaluates treatment documented in routine clinical records; no procedure is assigned for research purposes. | Procedure or surgery | SAVE-KNEE Retrospective Cohort |
| Ultrasound-Guided Radiofrequency AblationPercutaneous ultrasound-guided radiofrequency ablation targeting sensory nerves around the knee, performed as part of routine clinical care for chronic knee pain. Radiofrequency energy is used to produce controlled thermal neurolysis of the targeted nerve. This observational study evaluates treatment documented in routine clinical records; no procedure is assigned for research purposes. | Procedure or surgery | SAVE-KNEE Retrospective Cohort |
| Ultrasound-Guided Chemical NeurolysisPercutaneous ultrasound-guided chemical neurolysis targeting sensory nerves around the knee, performed as part of routine clinical care for chronic knee pain. A neurolytic agent is administered locally to interrupt nociceptive nerve transmission. This observational study evaluates treatment documented in routine clinical records; no procedure is assigned for research purposes. | Procedure or surgery | SAVE-KNEE Retrospective Cohort |
Primary outcome
Change from baseline in patient-reported knee pain on a 0-10 numeric rating scale (NRS)
Time frame: Pretreatment baseline; 1 month (+/-7 days), 6 months (+/-14 days), and 12 months (+/-30 days) after the procedure; only assessments performed on or before May 14, 2026
Change from baseline in patient-reported knee pain on a 0-10 NRS at 1, 6 and 12 months. Higher scores indicate greater pain; a decrease indicates improvement. Assessments were conducted in person or by telephone. When patients had difficulty selecting a number, verbal assistance included questions about pain severity, percentage or fractional improvement, and confirmation of a proposed numerical value. The final recorded 0-10 value was always stated or verbally confirmed by the patient, rather than assigned solely by the clinician. The use and extent of assistance cannot be determined for individual observations from the available records. Baseline is the patient-reported pain rating obtained on the day of the procedure, before it was performed.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time frame: Pretreatment baseline; 1 month (+/-7 days), 6 months (+/-14 days), and 12 months (+/-30 days) after the procedure; only assessments performed on or before May 14, 2026
Change in WOMAC total score from baseline to available assessments at 1, 6 and 12 months. The full questionnaire contains 24 items scored 0 (none) to 4 (extreme): 5 pain, 2 stiffness and 17 physical-function items. Total scores range from 0 to 96; higher scores indicate worse symptoms and function, and a decrease indicates improvement. During in-person visits, patients completed the questionnaire themselves. During telephone follow-up, an assistant read all 24 questions sequentially, entered the patient's responses into an interactive worksheet, and the worksheet calculated the total score. Analyses use raw total scores in participants with the required baseline and follow-up WOMAC data.
3 secondary outcomes
Number and proportion of treated knees with documented procedure-related adverse events or complications
Time frame: From the procedure until the earliest of 12 months after treatment, the last available follow-up, or May 14, 2026
Proportion of treated knees with at least 50% reduction in knee pain intensity
Time frame: Pretreatment baseline; 1 month (+/-7 days), 6 months (+/-14 days), and 12 months (+/-30 days) after the procedure; only assessments performed on or before May 14, 2026
Number and proportion of treated knees undergoing a repeat pain-relieving procedure
Time frame: From the index procedure until the earliest of 12 months after treatment, the last available follow-up, or May 14, 2026
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 23 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Chronic Knee Pain, run by Michał Bartoszewicz at 1 site in Poland.
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 8 inclusion and 4 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 23 Sep 2026. 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 Poland. 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?
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?
Change from baseline in patient-reported knee pain on a 0-10 numeric rating scale (NRS) (time frame: Pretreatment baseline; 1 month (+/-7 days), 6 months (+/-14 days), and 12 months (+/-30 days) after the procedure; only assessments performed on or before May 14, 2026). 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?
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 23 Sep 2026.