Dose-Response Association Between Cerclage Wire Number and Infection Risk (C-INFECT)

February 20, 2026 updated by: Yasar Samet Gokceoglu, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent surgical treatment for femoral shaft, subtrochanteric, or periprosthetic femoral fractures at two Level I trauma centers between April 2015 and January 2025.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I (Low Implant Burden)
Patients treated for femoral or periprosthetic fractures using only 1 metallic cerclage wire as an adjunct to primary fixation.
Procedure: 1 Metallic Cerclage Wiring
Application of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in complex femoral fractures
Group II (Moderate Implant Burden)
Patients treated for femoral or periprosthetic fractures using 2 metallic cerclage wires as an adjunct to primary fixation.
Procedure: 2 metalic cerclage wire
Application of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in femoral shaft, subtrochanteric, or periprosthetic fractures
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.
Procedure: 3 metalic cerclage wire
Patients receiving three or more (≥3) metallic wire or cable loops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of surgery until the date of first documented deep infection, assessed up to 12 months
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
From date of surgery until the date of first documented persistent wound drainage(> 5 days), assessed up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at 14 days following the date of surgery
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.
From the start of the surgery until the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Aksaray University Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2015

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

March 10, 2025

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ysrsmt123435
  • SAGETIK 2025-209 (Other Identifier: Ethics Committee Approval Number from Aksaray University Training and Research Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be made available upon publication

IPD Sharing Time Frame

Data will be available immediately following publication

IPD Sharing Access Criteria

Data are available within the manuscript and its supplementary materials for any researcher wishing to use the data for non-commercial purposes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Complications

Clinical Trials on 1 Metallic Cerclage Wiring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe