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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 746
- 试验地点
- 1
- 主要终点
- Change from baseline in patient-reported knee pain on a 0-10 numeric rating scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •Availability of WOMAC data determines inclusion in the functional-outcome analyses and is not required for the broader pain-outcome cohort.
排除标准
- •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,
- •Confirmed mechanical implant complications, including loosening or structural failure, or acute joint infection in patients after total knee arthroplasty.
研究组 & 干预措施
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.
干预措施: Ultrasound-Guided Cryoneurolysis (Procedure)
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.
干预措施: Ultrasound-Guided Radiofrequency Ablation (Procedure)
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.
干预措施: Ultrasound-Guided Chemical Neurolysis (Procedure)
结局指标
主要结局
Change from baseline in patient-reported knee pain on a 0-10 numeric rating scale (NRS)
时间窗: 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
时间窗: 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.
次要结局
- Number and proportion of treated knees with documented procedure-related adverse events or complications(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(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(From the index procedure until the earliest of 12 months after treatment, the last available follow-up, or May 14, 2026)
研究者
Michał Bartoszewicz
Sponsor-Investigator and Principal Investigator
Michał Bartoszewicz praktyka specjalistyczna