Dose Response Association Between Cerclage Construct Count and Deep Infection After Femoral and Periprosthetic Femoral Fracture Fixation: A Dual-Center Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 主要终点
- Incidence of Deep Infection (SSI/PJI)
研究概览
简要总结
The purpose of this dual-center retrospective study is to investigate the relationship between the number of metallic cerclage wires used in femoral fracture surgery and the risk of developing deep infections. Cerclage wiring is a common technique used to hold bone fragments together during the fixation of complex thigh bone (femur) or hip replacement-related (periprosthetic) fractures. While these wires provide mechanical stability, adding foreign material to the body may increase the risk of bacterial colonization and biofilm formation.
Researchers reviewed the medical records of 148 patients treated between 2015 and 2025 at two Level I trauma centers. Patients were divided into three groups based on the "implant burden": those with 1 wire, 2 wires, or 3 or more wires. The study evaluated two main complications:
Persistent wound drainage (PWD): Continued fluid leakage from the surgical site for more than 5 days.
Deep infection: Serious infections involving deep tissues or the bone that require additional surgery or long-term antibiotics.
The results showed a significant "dose-dependent" link, meaning that as the number of wires increased, the risk of drainage and infection also rose significantly, regardless of the length of the surgery. The study suggests that surgeons should use the minimum number of wires necessary to maintain stability to reduce these biological risks.
详细描述
This dual-center study evaluates the biological impact of "implant burden" in femoral fracture fixation, specifically examining whether the risk of surgical site infection (SSI) is dose-dependent on the number of cerclage constructs used. While cerclage wiring is a recognized adjunct for achieving anatomical reduction in complex subtrochanteric and periprosthetic fractures, the cumulative surface area of multiple braided cables may provide a protected niche for bacterial attachment and biofilm formation.
Surgical Protocol and Intervention:
All procedures were performed or supervised by fellowship-trained orthopedic trauma surgeons using a "biological fixation" strategy to prioritize the preservation of periosteal blood supply. For femoral shaft and subtrochanteric fractures, metallic cerclage wires or cables were applied via small accessory incisions or through direct lateral approaches. Monofilament wires were secured with symmetric twist knots, while multifilament braided cables were tensioned to 40-50 kg and secured with swaged crimp mechanisms. The cohort was stratified into three groups based on the final construct count verified by postoperative radiographs: Group I (1 wire), Group II (2 wires), and Group III (≥3 wires).
Clinical and Laboratory Monitoring:
Patients were monitored preoperatively and postoperatively (Days 1, 3, 7, 14) for inflammatory markers, including C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). Nutritional status was assessed via serum albumin levels on the first postoperative day. Wound complications were tracked, with persistent wound drainage (PWD) defined as drainage lasting more than 5 postoperative days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature adult patients (≥18 years old).
- •Diagnosis of femoral shaft, subtrochanteric, or periprosthetic femoral fractures (Vancouver Types B1, B2, and B3).
- •Surgical stabilization using metallic cerclage wires or cables as an adjunct to intramedullary nails or locking plates.
- •Minimum clinical and radiological follow-up of 12 months.
排除标准
- •Open fractures (Gustilo-Anderson types I-III).
- •Pathological fractures secondary to malignancy.
- •History of active infection or septic arthritis in the ipsilateral limb prior to the index procedure.
- •Treatment with non-metallic polymer cables.
研究组 & 干预措施
Group I (Low Implant Burden)
Patients treated for femoral or periprosthetic fractures using only 1 metallic cerclage wire as an adjunct to primary fixation.
干预措施: 1 Metallic Cerclage Wiring (Procedure)
Group II (Moderate Implant Burden)
Patients treated for femoral or periprosthetic fractures using 2 metallic cerclage wires as an adjunct to primary fixation.
干预措施: 2 metalic cerclage wire (Procedure)
Group III (High Implant Burden)
Patients treated for femoral or periprosthetic fractures using 3 or more (≥3) metallic cerclage wires as an adjunct to primary fixation.
干预措施: 3 metalic cerclage wire (Procedure)
结局指标
主要结局
Incidence of Deep Infection (SSI/PJI)
时间窗: From date of surgery until the date of first documented deep infection, assessed up to 12 months
Diagnosis of deep infection involving deep tissues, bone, or the implant, established in accordance with the Musculoskeletal Infection Society (MSIS) criteria. This includes cases requiring surgical intervention such as Debridement, Antibiotics, and Implant Retention (DAIR) or total implant removal with positive intraoperative cultures.
Persistent Wound Drainage (PWD) > 5 days
时间窗: From date of surgery until the date of first documented persistent wound drainage(> 5 days), assessed up to 30 days
The presence of continuous fluid leakage from the surgical incision site lasting more than 5 postoperative days
次要结局
- CRP Level at Postoperative Day 14(Assessed at 14 days following the date of surgery)
- Operative Duration(From the start of the surgery until the end of the surgery)
研究者
Yasar Samet Gokceoglu
Principal investigator
Sanliurfa Mehmet Akif Inan Education and Research Hospital