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Completed

NCT Number: NCT07434258

Dose-Response Association Between Cerclage Wire Number and Infection Risk

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.

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Key information

About this study

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.

Statistical Modeling:

To isolate the independent effect of cerclage count from potential confounders, a penalized (Firth) multivariable logistic regression model was utilized. This approach was selected to reduce small-sample bias and overfitting given the limited number of deep infection events. The core model adjusted for operative duration (continuous and >120 minutes), postoperative hypoalbuminemia (<3.0 g/dL), and fracture category (shaft, subtrochanteric, or periprosthetic). Infection-free survival across the three groups was estimated using the Kaplan-Meier method with log-rank (Mantel-Cox) comparisons.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

1 Metallic Cerclage Wiring

Procedure

Application of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in complex femoral fractures

2 metalic cerclage wire

Procedure

Application of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in femoral shaft, subtrochanteric, or periprosthetic fractures

3 metalic cerclage wire

Procedure

Patients receiving three or more (≥3) metallic wire or cable loops.

Primary outcomes

  1. Incidence of Deep Infection (SSI/PJI)

    Time frame: 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.

  2. Persistent Wound Drainage (PWD) > 5 days

    Time frame: 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

Secondary outcomes

  1. CRP Level at Postoperative Day 14

    Time frame: Assessed at 14 days following the date of surgery

    Evaluation of inflammatory kinetics through serum C-reactive protein (CRP) levels to detect delayed washout or secondary peaks.

  2. Operative Duration

    Time frame: From the start of the surgery until the end of the surgery

    Total surgical time in minutes as a measure of perioperative surgical burden.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Aksaray University Training and Research Hospital

Registry information

Official study title

Dose Response Association Between Cerclage Construct Count and Deep Infection After Femoral and Periprosthetic Femoral Fracture Fixation: A Dual-Center Retrospective Cohort Study

Acronym: C-INFECT

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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