吲哚美辛预防髋臼骨折手术后异位骨化会增加后壁不愈合的风险。

Indomethacin prophylaxis for heterotopic ossification after acetabular fracture surgery increases the risk for nonunion of the posterior wall.

机构信息

*Orthopaedic Trauma Service, Florida Orthopaedic Institute, Tampa, FL; and †Department of Orthopaedic Surgery, Harborview Medical Center, Seattle, WA.

出版信息

J Orthop Trauma. 2014 Jul;28(7):377-83. doi: 10.1097/BOT.0000000000000049.

DOI:10.1097/BOT.0000000000000049

PMID:24625922

Abstract

OBJECTIVES

To determine if indomethacin has a positive clinical effect for the prophylaxis of heterotopic ossification (HO) after acetabular fracture surgery. To determine whether indomethacin affects the union rate of acetabular fractures.

DESIGN

Prospective randomized double-blinded trial.

SETTING

Level 1 regional trauma center.

PATIENTS

Skeletally mature patients treated operatively for an acute acetabular fracture through a Kocher-Langenbeck approach.

INTERVENTION

Patients were randomly allocated to 1 of 4 groups comparing placebo (group 1) to 3 days (group 2), 1 week (group 3), and 6 weeks (group 4) of indomethacin treatment.

MAIN OUTCOME MEASUREMENTS

Factors analyzed included the overall incidence, Brooker class and volume of HO, radiographic union of the acetabular fracture, and pain. Patients were followed clinically and radiographically at 6 weeks, 3 months, 6 months, and 1 year. Serum levels of indomethacin were drawn at 1 month to assess compliance. Computed tomographic scans were performed at 6 months to assess healing and volume of HO.

RESULTS

Ninety-eight patients were enrolled into this study, 68 completed the follow-up and had the 6-month computed tomographic scan, and there was a 63% compliance rate with the treatment regimen. Overall incidence of HO was 67% for group 1, 29% for group 2 (P = 0.04), 29% for group 3 (P = 0.019), and 67% for group 4. The volume of HO formation was 17,900 mm for group 1, 33,800 mm for group 2, 6300 mm for group 3 (P = 0.005), and 11,100 mm for group 4. The incidence of radiographic nonunion was 19% for group 1, 35% for group 2, 24% for group 3, and 62% for group 4 (P = 0.012). Seventy-seven percent of the nonunions involved the posterior wall segment. Pain visual analog scores (VASs) were significantly higher for patients with radiographic nonunion (VAS 4 vs. VAS 1, P = 0.002).

CONCLUSIONS

Treatment with 6 weeks of indomethacin does not appear to have a therapeutic effect for decreasing HO formation after acetabular fracture surgery and appears to increase the incidence of nonunion. Treatment with 1 week of indomethacin may be beneficial for decreasing the volume of HO formation without increasing the incidence of nonunion.

LEVEL OF EVIDENCE

Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

摘要

目的

确定吲哚美辛对预防髋臼骨折手术后异位骨化（HO）是否具有临床疗效。确定吲哚美辛是否影响髋臼骨折的愈合率。

设计

前瞻性随机双盲试验。

地点

1 级区域创伤中心。

患者

通过 Kocher-Langenbeck 入路手术治疗急性髋臼骨折的骨骼成熟患者。

干预措施

患者随机分配至 4 组中的 1 组，比较安慰剂（第 1 组）与 3 天（第 2 组）、1 周（第 3 组）和 6 周（第 4 组）的吲哚美辛治疗。

主要观察指标

分析的因素包括总体发生率、Brooker 分级和 HO 体积、髋臼骨折的放射学愈合以及疼痛。患者在 6 周、3 个月、6 个月和 1 年时进行临床和放射学随访。在 1 个月时抽取吲哚美辛的血清水平以评估依从性。在 6 个月时进行 CT 扫描以评估愈合和 HO 体积。

结果

本研究共纳入 98 例患者，68 例完成了随访并进行了 6 个月的 CT 扫描，治疗方案的依从率为 63%。第 1 组 HO 的总体发生率为 67%，第 2 组为 29%（P=0.04），第 3 组为 29%（P=0.019），第 4 组为 67%。HO 形成的体积分别为第 1 组 17900mm³、第 2 组 33800mm³、第 3 组 6300mm³（P=0.005）和第 4 组 11100mm³。第 1 组的放射学不愈合发生率为 19%，第 2 组为 35%，第 3 组为 24%，第 4 组为 62%（P=0.012）。不愈合中有 77%涉及后壁段。放射学不愈合患者的疼痛视觉模拟评分（VAS）明显更高（VAS 4 比 VAS 1，P=0.002）。