Dose-Response Association Between Cerclage Wire Number and Infection Risk

NCT07434258 | Completed

• 2 other identifiers: ysrsmt123435SAGETIK 2025-209
• Study Type: observational
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Femur Fracture; Periprosthetic Fracture of Hip; Periprosthetic Fracture of the Femur; Surgical Site Infection (SSI); Biofilms; Postoperative Complications

Keywords

Cerclage Wire; Implant Burden; Persistent Wound Drainage; Dose-Response Relationship; Orthopedic Fixation Devices; Subtrochanteric Fractures; Biofilm Formation

Outcome Measures

Primary Outcomes (2)

• Incidence of Deep Infection (SSI/PJI)

  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

  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 Outcomes (2)

• 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

Study Arms (3)

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

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

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

Interventions

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

Group I (Low Implant Burden)

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

Group II (Moderate Implant Burden)

3 metalic cerclage wire PROCEDURE

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

Group III (High Implant Burden)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead
• Aksaray University Training and Research Hospital: collaborator

Related Publications (15)

• Trampuz A, Piper KE, Jacobson MJ, Hanssen AD, Unni KK, Osmon DR, Mandrekar JN, Cockerill FR, Steckelberg JM, Greenleaf JF, Patel R. Sonication of removed hip and knee prostheses for diagnosis of infection. N Engl J Med. 2007 Aug 16;357(7):654-63. doi: 10.1056/NEJMoa061588.

  PMID: 17699815 BACKGROUND

• Kim Y, Moon JK, Hwang KT, Choi IY, Kim YH. Cementless bipolar hemiarthroplasty for unstable intertrochanteric fractures in octogenarians. Acta Orthop Traumatol Turc. 2014;48(4):424-30. doi: 10.3944/AOTT.2014.13.0119.

  PMID: 25230266 BACKGROUND

• Apivatthakakul T, Phaliphot J, Leuvitoonvechkit S. Percutaneous cerclage wiring, does it disrupt femoral blood supply? A cadaveric injection study. Injury. 2013 Feb;44(2):168-74. doi: 10.1016/j.injury.2012.10.016. Epub 2012 Nov 17.

  PMID: 23164676 BACKGROUND

• Baumgaertner MR, Curtin SL, Lindskog DM, Keggi JM. The value of the tip-apex distance in predicting failure of fixation of peritrochanteric fractures of the hip. J Bone Joint Surg Am. 1995 Jul;77(7):1058-64. doi: 10.2106/00004623-199507000-00012.

  PMID: 7608228 BACKGROUND

• Parvizi J, Zmistowski B, Berbari EF, Bauer TW, Springer BD, Della Valle CJ, Garvin KL, Mont MA, Wongworawat MD, Zalavras CG. New definition for periprosthetic joint infection: from the Workgroup of the Musculoskeletal Infection Society. Clin Orthop Relat Res. 2011 Nov;469(11):2992-4. doi: 10.1007/s11999-011-2102-9. No abstract available.

  PMID: 21938532 BACKGROUND

• Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.

  PMID: 29551303 BACKGROUND

• Cichos KH, Christie MC, Ponce BA, Ghanem ES. Biofilm Growth on Orthopaedic Cerclage Materials: Nonmetallic Polymers Are Less Resistant to Methicillin-Resistant Staphylococcus Aureus Bacterial Adhesion. J Arthroplasty. 2024 Sep;39(9S2):S469-S475.e1. doi: 10.1016/j.arth.2024.04.042. Epub 2024 Apr 18.

  PMID: 38642854 BACKGROUND

• Lenz M, Perren SM, Richards RG, Muckley T, Hofmann GO, Gueorguiev B, Windolf M. Biomechanical performance of different cable and wire cerclage configurations. Int Orthop. 2013 Jan;37(1):125-30. doi: 10.1007/s00264-012-1702-7. Epub 2012 Nov 10.

  PMID: 23142812 BACKGROUND

• Perren SM, Fernandez Dell'oca A, Regazzoni P. Fracture Fixation Using Cerclage, Research Applied to Surgery. Acta Chir Orthop Traumatol Cech. 2015;82(6):389-97. No abstract available.

  PMID: 26787178 BACKGROUND

• Almeida RP, Mokete L, Sikhauli N, Sekeitto AR, Pietrzak J. The draining surgical wound post total hip and knee arthroplasty: what are my options? A narrative review. EFORT Open Rev. 2021 Oct 19;6(10):872-880. doi: 10.1302/2058-5241.6.200054. eCollection 2021 Oct.

  PMID: 34760287 BACKGROUND

• Moore K, Gupta N, Gupta TT, Patel K, Brooks JR, Sullivan A, Litsky AS, Stoodley P. Mapping Bacterial Biofilm on Features of Orthopedic Implants In Vitro. Microorganisms. 2022 Mar 8;10(3):586. doi: 10.3390/microorganisms10030586.

  PMID: 35336161 BACKGROUND

• Ziegenhain F, Canal C, Halvachizadeh S, Mittlmeier A, Pape HC, Hierholzer C, Neuhaus V. Outcome of femoral fractures treated with cerclages and intramedullary nailing. Eur J Trauma Emerg Surg. 2025 May 20;51(1):211. doi: 10.1007/s00068-025-02883-x.

  PMID: 40392364 BACKGROUND

• Kook I, Park KC, Kim KY, Jung I, Hwang KT. Efficacy of Minimally Invasive Reduction With Cerclage Fixation in Spiral or Oblique Subtrochanteric Femoral Fractures: A Retrospective Cohort Study Comparing Cables and Wires. J Orthop Trauma. 2024 Mar 1;38(3):160-167. doi: 10.1097/BOT.0000000000002738.

  PMID: 38098139 BACKGROUND

• Kim CH, Yoon YC, Kang KT. The effect of cerclage wiring with intramedullary nail surgery in proximal femoral fracture: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2022 Dec;48(6):4761-4774. doi: 10.1007/s00068-022-02003-z. Epub 2022 May 26.

  PMID: 35618854 BACKGROUND

• Hantouly AT, Salameh M, Toubasi AA, Salman LA, Alzobi O, Ahmed AF, Ahmed G. The role of cerclage wiring in the management of subtrochanteric and reverse oblique intertrochanteric fractures: a meta-analysis of comparative studies. Eur J Orthop Surg Traumatol. 2023 May;33(4):739-749. doi: 10.1007/s00590-022-03240-z. Epub 2022 Mar 21.

  PMID: 35377073 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures; Surgical Wound Infection; Postoperative Complications; Hip Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hip Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 25, 2026
• Study Start: April 10, 2015
• Primary Completion: January 20, 2025
• Study Completion: March 10, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available immediately following publication
• Access Criteria: Data are available within the manuscript and its supplementary materials for any researcher wishing to use the data for non-commercial purposes