非接触式低频超声清创技术治疗假体周围感染早期效果的前瞻性单臂临床研究

The short-term outcomes of non-contact low frequency ultrasonic debridement in treating periprosthetic joint infections:a prospective single-arm clinical study

目的探讨非接触式低频超声清创技术治疗假体周围感染(PJI)的早期效果。方法前瞻性纳入2021年8月至2022年1月新疆医科大学第一附属医院骨科应用非接触式低频超声清创技术治疗的符合纳入和排除标准的假体周围感染患者。参考2016年肌肉与骨骼感染协会对PJI的诊断标准进行感染诊断。所有患者在机械清创完成后使用8 mm手持式非接触低频超声探头在整个术区进行超声清创(功率90%、频率22.5 kHz,每次持续10 s,暂停3 s,共5 min)。期间通过移动探头在术区所有软组织、骨界面及金属假体表面[行保留假体清创术联合抗菌药物(DAIR)治疗者]之间反复振荡。对髋关节股骨髓腔和膝关节股骨髓腔及后方关节囊,使用特制直角探头充分振荡。超声振荡前后各抽取术区液体20 ml分别注入需氧培养瓶及厌氧培养瓶行病原菌培养。采用Harris髋关节评分和美国特种外科医院(HSS)膝关节评分评估患肢功能。治疗失败定义为同一关节感染复发。患者术后1个月、3个月、6个月、1年及之后每年门诊随访一次,随访截止时间为2022年8月。各种观察数据的比较采用配对t检验、秩和检验、Mann-Whitney U检验或χ^(2)检验,采用Bonferroni方法进行多组间率的两两比较。结果研究中共纳入45例患者,男性21例,女性24例;年龄(65.8±15.2)岁(范围:20~80岁),体重指数(29.3±4.2)kg/m^(2)(范围:20.2~38.5 kg/m^(2))。其中28例(18例髋、10例膝)接受一期人工关节翻修术,17例(5例髋、12例膝)接受DAIR治疗。至随访结束,3例(6.7%,3/45)患者感染复发。所有患者未见术区超声振荡相关并发症(神经、血管、肌肉损伤,切口愈合不良,脂肪液化)。17例接受DAIR治疗患者的随访时间[M(IQR)]为9(3)个月,2例分别于术后3周和3个月感染复发。28例接受一期翻修患者的随访时间为9(2)个月,1例于术后6个月感染复发。术前穿刺液病原菌培养的阳性率为47.6%(20/42),术中软组织培养的阳性率为86.7%(39/45),术区低频超声清创前液体培养的阳性率为46.7%(21/45),经过低频超声清创后培养的阳性率为75.6%(34/45),假体离体超声振荡培养的阳性率为88.9%(40/45),5次培养阳性率的差异有统计学意义(χ^(2)=35.483,P<0.01)。进一步两两比较结果显示,术区低频超声清创后病原菌培养的阳性率高于超声清创前液体培养阳性率(χ^(2)=7.901,P=0.005),其余培养方法阳性率的两两比较,差异均无统计学意义(P值均>0.05)。低频超声清创后术区液体接种24 h菌落量为2240(1310)CFU/ml(范围:310~3140 CFU/ml),多于振荡前的450(550)CFU/ml(范围:10~910 CFU/ml)(U=43,P=0.017)。髋关节术后患者的Harris评分和膝关节术后患者的HSS膝关节评分分别为(78.6±4.2)分(范围:70.5~85.3分)和(76.4±4.8)分(范围:68.5~84.3分),较术前[(46.0±9.8)分(范围:27.5~64.3分)和(45.5±10.3)分(范围:27.6~63.1分)]显著提升(t=-14.6、-12.7,P值均<0.01)。结论非接触式低频超声清创可增加术中病原菌培养的阳性率,短期随访感染控制率良好,在患者深部关节腔内使用未见相关并发症。

Objective To evaluate the short-term outcomes of non-contact low-frequency ultrasonic debridement in treating periprosthetic joint infections(PJI).Methods The clinical data of patients with PJI who met the eligibility criteria and were treated with non-contact low-frequency ultrasonic debridement from August 2021 to January 2022 at the Department of Orthopaedics,the First Affiliated Hospital of Xinjiang Medical University were prospectively analyzed.PJI was defined according to the modified Musculoskeletal Infection Society criteria in 2016.After mechanical debridement,an 8-mm handheld non-contact low-frequency ultrasound probe was used for ultrasonic debridement in the whole surgical area at a frequency of(25±5)kHz and power of 90%for 5 minutes.Each ultrasound lasted 10 seconds with 3-second intervals.The probe was repeatedly sonicated among all soft tissue,bone interface and metal prosthesis surface(patients underwent debridement,antibiotics and implant retention(DAIR))in the surgical area.The femoral canal of the hip joint,the distal femoral canal and the posterior capsule of the knee were fully sonicated with a special right-angle probe.Before and after ultrasonic debridement,20 ml of liquid was extracted from each operation area and injected into aerobic and anaerobic culture bottles,respectively,for pathogen culture.Harris hip score and Hospital for Special Surgery(HSS)score were used to evaluate clinical function.Treatment failure was defined as the recurrence of infection in the same joint.The patients were routinely followed up in the outpatient clinic at 1,3,and 6 months postoperatively and then annually with a deadline of August 2022.The paired t-test,rank sum,Mann-Whitney U orχ^(2) test was used to compare the observed data,and rates among multiple groups were compared using the Bonferroni approach.Results A total of 45 patients were included in the study,including 21 men and 24 women with age of(65.8±15.2)years(range:20 to 80 years)and body mass index of(29.3±4.2)kg/m^(2)(range:20.2 to 38.5 kg/m^(2)).Twenty-eight patients(18 hips and 10 knees)underwent one-stage revision,and 17 cases(5 hips and 12 knees)underwent DAIR.Three of the patients(6.7%)had recurrent infections during follow-up.There were no intraoperative complications related to ultrasonic debridement(neurovascular and muscle injury,poor wound healing and fat liquefaction).Seventeen patients who received DAIR were followed for a median(M(IQR))of 9(3)months,and two relapsed 3 weeks and 3 months post-operation,respectively.In addition,28 patients who underwent one-stage revision were followed for a median of 9(2)months,and one of the patients(3.6%,1/28)had a recurrence 6 months post-operation.The culture-positive rate of preoperative aspiration was 47.6%(20/42).The data of intraoperative soft tissue culture was 86.7%(39/45).The culture-positive rate of wound liquid before ultrasonic debridement was 46.7%(21/45).And the culture-positive rate after ultrasonic debridement was(75.6%(34/45)).After sonication,the culture-positive rate of explanted prostheses was 88.9%(40/45).There was a significant difference in culture-positive rates among all five cultures(χ^(2)=35.483,P<0.01).Further pairwise comparison showed that the culture-positive rate of wound liquid after ultrasonic debridement was higher than that before ultrasonic debridement(χ^(2)=7.901,P=0.005)but was not significantly different from the positive rates of other cultures(all P>0.05).The median number of colonies 24 hours after ultrasonic debridement(2240(1310)CFU/ml,range:310 to 3140 CFU/ml)was significantly higher than that before debridement(450(550)CFU/ml,range:10 to 910 CFU/ml)(U=43,P=0.017).The post-operative Harris((78.6±4.2)points,range:70.5 to 85.3 points)and HSS scores((76.4±4.8)points,range:68.5 to 84.3 points)were significantly higher than the preoperative scores((46.0±9.8)points,range:27.5 to 64.3 points;and(45.5±10.3)points,range:27.6 to 63.1 points)(t=-14.6,t=-12.7;both P<0.01).Conclusions Non-contact low-frequency ultrasonic debridement can increase the culture-positive rate and lead to a favorable short-term outcome.In addition,no complications are associated with using this new technique to treat PJI.