Abstract：
BACKGROUND: Total knee arthroplasty (TKA) is performed on approximately 790,000 patients annually in the United States and is projected to increase to 1.5 million by 2050. This study aimed at assessing the use of preoperative cryoneurolysis on patients undergoing TKA by analyzing: 1) pain severity; 2) opioid use; 3) functional status; and 4) sleep disturbance over 6 months following discharge.
METHODS: Patients enrolled in the Innovations in Genicular Outcomes Registry (iGOR) between September 2021 and February 2024 were followed for 6 months. Our analyses included patients undergoing unilateral primary TKA with no pre-operative opioid prescription who either received, or did not receive, cryoneurolysis. Baseline patient demographics were collected before TKA and tabulated. Pain management was assessed via the Brief Pain Inventory-Short Form (BPI-SF) instrument for pain severity. Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Each outcome measure was assessed prior to TKA, weekly, and at monthly follow-up. Data was analyzed by a generalized linear mixed-effect regression model to compare cryoneurolysis versus control patients, with a P < 0.05 as significant.
RESULTS: There were 80 patients who were treated with preoperative cryoneurolysis, while 60 control patients did not have treatment. Patients receiving cryoneurolysis experienced significantly lower pain severity and sleep disturbance over the 6-month follow-up than control patients (P = 0.046). Cryoneurolysis was also associated with a trend toward greater functional improvement that did not reach statistical significance (P = 0.061). Further, patients who underwent cryoneurolysis were 72% less likely than controls to take opioids over six months following discharge (P <0.001).
CONCLUSIONS: Pre-operative cryoneurolysis therapy in opioid-naïve patients undergoing TKA is associated with improved pain, decreased opioid use, and improved sleep disturbance for 6 months postoperatively. Cryoneurolysis, a non-opioid pain relief modality administered pre-operatively, demonstrated substantial benefits in patients who underwent TKA.
METHODS: Patients enrolled in the Innovations in Genicular Outcomes Registry (iGOR) between September 2021 and February 2024 were followed for 6 months. Our analyses included patients undergoing unilateral primary TKA with no pre-operative opioid prescription who either received, or did not receive, cryoneurolysis. Baseline patient demographics were collected before TKA and tabulated. Pain management was assessed via the Brief Pain Inventory-Short Form (BPI-SF) instrument for pain severity. Sleep disturbance was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire. Each outcome measure was assessed prior to TKA, weekly, and at monthly follow-up. Data was analyzed by a generalized linear mixed-effect regression model to compare cryoneurolysis versus control patients, with a P < 0.05 as significant.
RESULTS: There were 80 patients who were treated with preoperative cryoneurolysis, while 60 control patients did not have treatment. Patients receiving cryoneurolysis experienced significantly lower pain severity and sleep disturbance over the 6-month follow-up than control patients (P = 0.046). Cryoneurolysis was also associated with a trend toward greater functional improvement that did not reach statistical significance (P = 0.061). Further, patients who underwent cryoneurolysis were 72% less likely than controls to take opioids over six months following discharge (P <0.001).
CONCLUSIONS: Pre-operative cryoneurolysis therapy in opioid-naïve patients undergoing TKA is associated with improved pain, decreased opioid use, and improved sleep disturbance for 6 months postoperatively. Cryoneurolysis, a non-opioid pain relief modality administered pre-operatively, demonstrated substantial benefits in patients who underwent TKA.
摘要：
背景：全膝关节置换术（TKA）在美国每年对大约790,000名患者进行，预计到2050年将增加到150万。这项研究旨在通过分析评估术前冷冻神经溶解在接受TKA的患者中的使用：1）疼痛严重程度；2）阿片类药物的使用；3）功能状态；和4）出院后6个月内的睡眠障碍。
方法：在2021年9月至2024年2月期间参加遗传学结果登记创新（iGOR）的患者随访6个月。我们的分析包括接受单侧原发性TKA但没有术前阿片类药物处方的患者，或者没有收到，冷冻神经裂解。在TKA之前收集基线患者人口统计学并制成表格。通过疼痛严重程度的简短疼痛清单（BPI-SF）工具评估疼痛管理。使用患者报告结果测量信息系统（PROMIS）问卷测量睡眠障碍。在TKA之前评估每个结果指标，每周,每月随访。通过广义线性混合效应回归模型分析数据，以比较冷冻神经溶解与对照患者，P<0.05为显著。
结果：有80例患者接受了术前冷冻神经溶解治疗，而60名对照患者没有接受治疗。在6个月的随访中，接受冷冻神经溶解的患者的疼痛严重程度和睡眠障碍明显低于对照组患者（P=0.046）。冷冻神经溶解还与功能改善趋势相关，但未达到统计学意义（P=0.061）。Further,接受冷冻神经溶解的患者在出院后6个月内服用阿片类药物的可能性比对照组低72%(P<0.001).
结论：接受TKA的阿片类药物初治患者的术前冷冻神经溶解治疗与疼痛改善有关，减少阿片类药物的使用，术后6个月睡眠障碍得到改善。冷冻神经裂解，术前给予非阿片类疼痛缓解方式，在接受TKA的患者中显示出实质性的益处。
方法：在2021年9月至2024年2月期间参加遗传学结果登记创新（iGOR）的患者随访6个月。我们的分析包括接受单侧原发性TKA但没有术前阿片类药物处方的患者，或者没有收到，冷冻神经裂解。在TKA之前收集基线患者人口统计学并制成表格。通过疼痛严重程度的简短疼痛清单（BPI-SF）工具评估疼痛管理。使用患者报告结果测量信息系统（PROMIS）问卷测量睡眠障碍。在TKA之前评估每个结果指标，每周,每月随访。通过广义线性混合效应回归模型分析数据，以比较冷冻神经溶解与对照患者，P<0.05为显著。
结果：有80例患者接受了术前冷冻神经溶解治疗，而60名对照患者没有接受治疗。在6个月的随访中，接受冷冻神经溶解的患者的疼痛严重程度和睡眠障碍明显低于对照组患者（P=0.046）。冷冻神经溶解还与功能改善趋势相关，但未达到统计学意义（P=0.061）。Further,接受冷冻神经溶解的患者在出院后6个月内服用阿片类药物的可能性比对照组低72%(P<0.001).
结论：接受TKA的阿片类药物初治患者的术前冷冻神经溶解治疗与疼痛改善有关，减少阿片类药物的使用，术后6个月睡眠障碍得到改善。冷冻神经裂解，术前给予非阿片类疼痛缓解方式，在接受TKA的患者中显示出实质性的益处。
