Ultrasound-guided Hydrogel Injection Provides Better Therapeutic Effects After Hand Tendon Surgery Than Intraoperative Injection: A Randomized Controlled Trial.

IF 4.2 2区 医学 Q1 ORTHOPEDICS Clinical Orthopaedics and Related Research® Pub Date : 2024-11-01 Epub Date: 2024-07-12 DOI:10.1097/CORR.0000000000003144
Weiguang Yin, Xuanzhe Liu, Kai Wang, Li Shen, Yuange Li, Qianying Cai, Shengbao Chen, Jie Chen, Shen Liu
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(2) Does ultrasound-guided postoperative application of hydrogels result in lower pain, better function, and better satisfaction?</p><p><strong>Methods: </strong>This open-label, prospective, single-center, randomized controlled trial was conducted by reparative and reconstructive surgeons at the National Orthopedics Clinical Medical Center, Shanghai, People's Republic of China. Between May 2021 and December 2022, 53% (168 of 317) of patients who met our inclusion criteria were recruited, and 47% (149 of 317) of patients were excluded because of the exclusion criteria. Finally, 84 patients were randomized to the postoperative group to receive ultrasound-guided carboxymethyl chitosan (CMC) hydrogel delayed injection, and 84 patients were randomized to the intraoperative group to receive CMC hydrogel intraoperative application. Another 8% (7 of 84) of patients in the postoperative group and 10% (8 of 84) of patients in the intraoperative group were lost before the minimum study follow-up time of 1 year or had incomplete datasets, leaving 91% (153 of 168) of patients with data for analysis. Data on outcome events were analyzed according to the intention-to-treat principle, which included all patients who underwent randomization. Follow-up visits were completed at 3 weeks, 6 weeks, 3 months, 6 months, and 12 months after tendon repair. The primary outcome was TAM (ie, the sum of the degrees of active metacarpophalangeal joint, proximal interphalangeal joint, and distal interphalangeal joint flexion less the degrees from full extension; minimum clinically important difference [MCID] 20°) at 12 months. Secondary outcomes included pain (measured with a VAS; range 0 to 10, a higher score indicating worse pain; MCID 0.6), Michigan Hand Outcomes Questionnaire activities of daily living (MHQ-ADL) score (range 0 to 100, a higher score indicating better outcomes; MCID 10.1), and MHQ satisfaction (MHQ-SAT) score (range 0 to 100, a higher score indicating better outcomes; MCID 33.0).</p><p><strong>Results: </strong>At 12 months, the ultrasound-guided postoperative injection group had improved TAM (intraoperative 189° [95% CI 179° to 199°] versus postoperative 209° [95% CI 199° to 219°], mean difference 20° [95% CI 6° to 35°]; p = 0.006; the mean difference in the primary outcome fulfilled the MCID value at all time points). At 6 weeks, we found no clinically important difference in VAS pain scores among groups (intraoperative mean ± SD 2.0 ± 1.0 versus postoperative 1.7 ± 1.0, mean difference 0.3 [95% CI 0.1 to 0.7]; p = 0.02); however, at 3 weeks, the VAS pain scores showed clinically important difference among groups (3.6 ± 1.4 versus 2.9 ± 1.2, mean difference 0.7 [95% CI 0.3 to 1.1]; p = 0.001). At 3 months, the ultrasound-guided postoperative injection group had higher MHQ-ADL scores (intraoperative 62 ± 10 versus postoperative 75 ± 10, mean difference 13 [95% CI 11 to 17]; p < 0.001), and the mean difference of MHQ-ADL scores reached the MCID value at all time points. 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Clinical trials are needed to confirm the safety and efficacy of ultrasound-guided postoperative injection of CMC hydrogels and to determine the most effective dose and the health and economic benefits of treatment.</p><p><strong>Level of evidence: </strong>Level I, therapeutic study.</p>","PeriodicalId":10404,"journal":{"name":"Clinical Orthopaedics and Related Research®","volume":null,"pages":null},"PeriodicalIF":4.2000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11469842/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Orthopaedics and Related Research®","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/CORR.0000000000003144","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/12 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Hydrogels are used to provide a barrier against peritendinous adhesion formation, but when implanted intraoperatively, they degrade rapidly and aggravate early inflammatory pain. It is uncertain whether clinical efficacy can be improved by avoiding the inflammatory phase when hydrogels are delivered during adhesion formation.

Questions/purposes: (1) Compared with intraoperative hydrogel application, does ultrasound-guided postoperative application result in better total active motion (TAM) at 12 months after tendon injury? (2) Does ultrasound-guided postoperative application of hydrogels result in lower pain, better function, and better satisfaction?

Methods: This open-label, prospective, single-center, randomized controlled trial was conducted by reparative and reconstructive surgeons at the National Orthopedics Clinical Medical Center, Shanghai, People's Republic of China. Between May 2021 and December 2022, 53% (168 of 317) of patients who met our inclusion criteria were recruited, and 47% (149 of 317) of patients were excluded because of the exclusion criteria. Finally, 84 patients were randomized to the postoperative group to receive ultrasound-guided carboxymethyl chitosan (CMC) hydrogel delayed injection, and 84 patients were randomized to the intraoperative group to receive CMC hydrogel intraoperative application. Another 8% (7 of 84) of patients in the postoperative group and 10% (8 of 84) of patients in the intraoperative group were lost before the minimum study follow-up time of 1 year or had incomplete datasets, leaving 91% (153 of 168) of patients with data for analysis. Data on outcome events were analyzed according to the intention-to-treat principle, which included all patients who underwent randomization. Follow-up visits were completed at 3 weeks, 6 weeks, 3 months, 6 months, and 12 months after tendon repair. The primary outcome was TAM (ie, the sum of the degrees of active metacarpophalangeal joint, proximal interphalangeal joint, and distal interphalangeal joint flexion less the degrees from full extension; minimum clinically important difference [MCID] 20°) at 12 months. Secondary outcomes included pain (measured with a VAS; range 0 to 10, a higher score indicating worse pain; MCID 0.6), Michigan Hand Outcomes Questionnaire activities of daily living (MHQ-ADL) score (range 0 to 100, a higher score indicating better outcomes; MCID 10.1), and MHQ satisfaction (MHQ-SAT) score (range 0 to 100, a higher score indicating better outcomes; MCID 33.0).

Results: At 12 months, the ultrasound-guided postoperative injection group had improved TAM (intraoperative 189° [95% CI 179° to 199°] versus postoperative 209° [95% CI 199° to 219°], mean difference 20° [95% CI 6° to 35°]; p = 0.006; the mean difference in the primary outcome fulfilled the MCID value at all time points). At 6 weeks, we found no clinically important difference in VAS pain scores among groups (intraoperative mean ± SD 2.0 ± 1.0 versus postoperative 1.7 ± 1.0, mean difference 0.3 [95% CI 0.1 to 0.7]; p = 0.02); however, at 3 weeks, the VAS pain scores showed clinically important difference among groups (3.6 ± 1.4 versus 2.9 ± 1.2, mean difference 0.7 [95% CI 0.3 to 1.1]; p = 0.001). At 3 months, the ultrasound-guided postoperative injection group had higher MHQ-ADL scores (intraoperative 62 ± 10 versus postoperative 75 ± 10, mean difference 13 [95% CI 11 to 17]; p < 0.001), and the mean difference of MHQ-ADL scores reached the MCID value at all time points. At 3 months, there was no clinically important difference in MHQ-SAT scores between groups (intraoperative 62 ± 8 versus postoperative 70 ± 8, mean difference 8 [95% CI 6 to 11]; p < 0.001).

Conclusion: Compared with intraoperative CMC hydrogel injection, postoperative ultrasound-guided injection improved the TAM and function of the affected limb, showed a short-term pain control effect, and did not increase the risk of complications. Clinical trials are needed to confirm the safety and efficacy of ultrasound-guided postoperative injection of CMC hydrogels and to determine the most effective dose and the health and economic benefits of treatment.

Level of evidence: Level I, therapeutic study.

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超声引导水凝胶注射比术中注射在手部肌腱手术后提供更好的治疗效果:随机对照试验。
背景:水凝胶可用于阻隔腱周粘连的形成,但在术中植入时,水凝胶会迅速降解并加重早期炎症性疼痛。问题/目的:(1) 与术中应用水凝胶相比,术后超声引导下应用水凝胶是否能在肌腱损伤后 12 个月内获得更好的完全主动运动(TAM)效果?(2)超声引导下术后应用水凝胶是否能降低疼痛、改善功能和提高满意度?这项开放标签、前瞻性、单中心、随机对照试验由中华人民共和国上海国家骨科临床医学中心的修复与重建外科医生进行。在 2021 年 5 月至 2022 年 12 月期间,符合纳入标准的患者中有 53% (317 例中的 168 例)被招募,47% 的患者(317 例中的 149 例)因排除标准而被排除。最后,84 名患者被随机分配到术后组,接受超声引导下的羧甲基壳聚糖(CMC)水凝胶延迟注射,84 名患者被随机分配到术中组,接受 CMC 水凝胶术中应用。另有8%的术后组患者(84人中的7人)和10%的术中组患者(84人中的8人)在最短的1年研究随访时间前死亡或数据集不完整,因此有91%的患者(168人中的153人)的数据可供分析。结果事件的数据按照意向治疗原则进行分析,包括所有接受随机化的患者。随访时间分别为肌腱修复后 3 周、6 周、3 个月、6 个月和 12 个月。主要结果是 12 个月时的 TAM(即掌指关节、近端指间关节和远端指间关节活动屈曲度数减去完全伸展度数的总和;最小临床重要差异 [MCID] 20°)。次要结果包括疼痛(用VAS测量;范围0至10,得分越高表示疼痛越严重;MCID 0.6)、密歇根手部结果问卷日常生活活动(MHQ-ADL)得分(范围0至100,得分越高表示结果越好;MCID 10.1)和MHQ满意度(MHQ-SAT)得分(范围0至100,得分越高表示结果越好;MCID 33.0):12个月时,超声引导下术后注射组的TAM有所改善(术中189° [95% CI 179°至199°] 与术后209° [95% CI 199°至219°],平均差20° [95% CI 6°至35°];P = 0.006;主要结果的平均差在所有时间点均达到MCID值)。在 6 周时,我们发现各组间的 VAS 疼痛评分没有临床意义上的差异(术中平均 ± SD 2.0 ± 1.0 对术后 1.7 ± 1.0,平均差 0.3 [95% CI 0.1 至 0.7];p = 0.02);但在 3 周时,各组间的 VAS 疼痛评分显示出临床意义上的差异(3.6 ± 1.4 对 2.9 ± 1.2,平均差 0.7 [95% CI 0.3 至 1.1];p = 0.001)。3 个月时,超声引导下术后注射组的 MHQ-ADL 评分更高(术中 62 ± 10 对术后 75 ± 10,平均差 13 [95% CI 11 至 17];P < 0.001),且所有时间点的 MHQ-ADL 评分平均差均达到 MCID 值。3个月时,各组间的MHQ-SAT评分没有临床意义上的差异(术中62±8分,术后70±8分,平均差8[95% CI 6至11];P <0.001):与术中注射 CMC 水凝胶相比,术后超声引导注射改善了患肢的 TAM 和功能,显示出短期疼痛控制效果,且不会增加并发症风险。需要进行临床试验来确认超声引导下术后注射 CMC 水凝胶的安全性和有效性,并确定最有效的剂量以及治疗的健康和经济效益:证据等级:一级,治疗研究。
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来源期刊
CiteScore
7.00
自引率
11.90%
发文量
722
审稿时长
2.5 months
期刊介绍: Clinical Orthopaedics and Related Research® is a leading peer-reviewed journal devoted to the dissemination of new and important orthopaedic knowledge. CORR® brings readers the latest clinical and basic research, along with columns, commentaries, and interviews with authors.
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