Rodríguez-Maruri Guillermo, Rojo-Manaute Jose Manuel, Capa-Grasa Alberto, Rodríguez Francisco Chana, Del Cerro Gutierrez Miguel, Martín Javier Vaquero
Department Physical and Rehabilitation Medicine, University Hospital Marqués de Valdecilla, Santander, Spain.
Unit of Hand Surgery, Department of Orthopedics, Medcare Orthopaedics and Spine Hospital, Dubai, UAE.
Oman Med J. 2022 Mar 22;37(2):e360. doi: 10.5001/omj.2022.49. eCollection 2022 Mar.
The most common surgical option for releasing the first annular pulley in trigger digit (TD) is classic open surgery followed by blind percutaneous release. However, they have been related to major complications and incomplete releases, respectively. Intrasheath sonographically-guided first annular pulley release has recently been shown to be safe and effective in every digit. The objectives of this pilot study were to preliminary compare clinically an intrasheath sonographically-guided first annular pulley release versus a classic open technique and to evaluate the feasibility of a future clinical trial in patients with TDs.
Thirty patients were randomized 1:1 in an external pilot study comparing the two surgical techniques: a percutaneous sonographically-guided release performed through a 1 mm incision using a hook knife versus a classic open surgery with a 1 cm incision. Inclusion criteria were primary TD grade III (Froimson). We defined success if primary (safety and efficacy) and secondary (recruitment rates, compliance, completion, treatment blinding, personnel resources, and sample size calculation for the clinical trial) objectives could be matched. We registered the grip strength, the QuickDASH score and a set of postoperative clinical variables at one, three, and six weeks and at three months. We calculated the sample size for the clinical trial using the QuickDASH at the end of the follow-up. Outcomes assessors were blinded.
All patients in both groups showed resolution of their symptoms with no associated complications or relapses. Secondary feasibility objectives were matched: 76.9% of eligible patients were included in the study, 3.3% refused randomization, 20 patients per month were recruited, 100% received blinded treatment, 98.5% showed compliance, and 100% completed the study. The sample size for a future clinical trial was 84 patients. There were no differences in grip strength. The intrasheath sonographically-guided first annular pulley release showed significantly better QuickDASH scores, until the sixth postoperative week.
The intrasheath sonographically-guided first annular pulley release is safe and efficacious, and shows a trend toward clinical superiority versus the classic open procedure, which should be confirmed with a clinical trial. Our study shows that a randomized clinical trial is feasible.
扳机指（TD）中最常见的第一环状滑车松解手术方式是传统开放手术，其次是盲目经皮松解。然而，它们分别与严重并发症和松解不完全相关。鞘内超声引导下第一环状滑车松解术最近已被证明对每个手指都安全有效。本前瞻性研究的目的是对鞘内超声引导下第一环状滑车松解术与传统开放技术进行初步临床比较，并评估未来对扳机指患者进行临床试验的可行性。
在一项外部前瞻性研究中，30例患者按1:1随机分组，比较两种手术技术：使用钩刀经1mm切口进行超声引导下经皮松解与经1cm切口进行传统开放手术。纳入标准为原发性III级扳机指（弗罗伊姆森分级）。如果主要目标（安全性和有效性）和次要目标（招募率、依从性、完成情况、治疗设盲、人力资源以及临床试验的样本量计算）能够实现，我们则定义为成功。我们记录了1周、3周、6周和3个月时的握力、QuickDASH评分以及一组术后临床变量。随访结束时，我们使用QuickDASH计算临床试验的样本量。结果评估者设盲。
两组所有患者症状均得到缓解，无相关并发症或复发。次要可行性目标均已实现：76.9%的符合条件患者纳入研究，3.3%拒绝随机分组，每月招募20例患者，100%接受设盲治疗，98.5%表现出依从性，100%完成研究。未来临床试验的样本量为84例患者。握力无差异。鞘内超声引导下第一环状滑车松解术在术后第六周前的QuickDASH评分显著更好。
鞘内超声引导下第一环状滑车松解术安全有效，与传统开放手术相比显示出临床优势趋势，这一点应通过临床试验加以证实。我们的研究表明随机临床试验是可行的。
