Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:32 AM
Study NCT ID:
NCT07434258
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-Response Association Between Cerclage Wire Number and Infection Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Deep Infection (SSI/PJI)', 'timeFrame': 'From date of surgery until the date of first documented deep infection, assessed up to 12 months', 'description': '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.'}, {'measure': 'Persistent Wound Drainage (PWD) > 5 days', 'timeFrame': 'From date of surgery until the date of first documented persistent wound drainage(> 5 days), assessed up to 30 days', 'description': 'The presence of continuous fluid leakage from the surgical incision site lasting more than 5 postoperative days'}], 'secondaryOutcomes': [{'measure': 'CRP Level at Postoperative Day 14', 'timeFrame': 'Assessed at 14 days following the date of surgery', 'description': 'Evaluation of inflammatory kinetics through serum C-reactive protein (CRP) levels to detect delayed washout or secondary peaks.'}, {'measure': 'Operative Duration', 'timeFrame': 'From the start of the surgery until the end of the surgery', 'description': 'Total surgical time in minutes as a measure of perioperative surgical burden.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerclage Wire', 'Implant Burden', 'Persistent Wound Drainage', 'Dose-Response Relationship', 'Orthopedic Fixation Devices', 'Subtrochanteric Fractures', 'Biofilm Formation'], 'conditions': ['Femur Fracture', 'Periprosthetic Fracture of Hip', 'Periprosthetic Fracture of the Femur', 'Surgical Site Infection (SSI)', 'Biofilms', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '17699815', 'type': 'BACKGROUND', 'citation': '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': '25230266', 'type': 'BACKGROUND', 'citation': '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': '23164676', 'type': 'BACKGROUND', 'citation': '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': '7608228', 'type': 'BACKGROUND', 'citation': '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': '21938532', 'type': 'BACKGROUND', 'citation': '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': '29551303', 'type': 'BACKGROUND', 'citation': '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': '38642854', 'type': 'BACKGROUND', 'citation': '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': '23142812', 'type': 'BACKGROUND', 'citation': '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': '26787178', 'type': 'BACKGROUND', 'citation': "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': '34760287', 'type': 'BACKGROUND', 'citation': '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': '35336161', 'type': 'BACKGROUND', 'citation': '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': '40392364', 'type': 'BACKGROUND', 'citation': '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': '38098139', 'type': 'BACKGROUND', 'citation': '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': '35618854', 'type': 'BACKGROUND', 'citation': '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': '35377073', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nResearchers 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:\n\nPersistent wound drainage (PWD): Continued fluid leakage from the surgical site for more than 5 days.\n\nDeep infection: Serious infections involving deep tissues or the bone that require additional surgery or long-term antibiotics.\n\nThe 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.', 'detailedDescription': '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.\n\nSurgical Protocol and Intervention:\n\nAll 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).\n\nClinical and Laboratory Monitoring:\n\nPatients 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.\n\nStatistical Modeling:\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletally mature adult patients (≥18 years old).\n* Diagnosis of femoral shaft, subtrochanteric, or periprosthetic femoral fractures (Vancouver Types B1, B2, and B3).\n* Surgical stabilization using metallic cerclage wires or cables as an adjunct to intramedullary nails or locking plates.\n* Minimum clinical and radiological follow-up of 12 months.\n\nExclusion Criteria:\n\n* Open fractures (Gustilo-Anderson types I-III).\n* Pathological fractures secondary to malignancy.\n* History of active infection or septic arthritis in the ipsilateral limb prior to the index procedure.\n* Treatment with non-metallic polymer cables.'}, 'identificationModule': {'nctId': 'NCT07434258', 'acronym': 'C-INFECT', 'briefTitle': 'Dose-Response Association Between Cerclage Wire Number and Infection Risk', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Dose Response Association Between Cerclage Construct Count and Deep Infection After Femoral and Periprosthetic Femoral Fracture Fixation: A Dual-Center Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'ysrsmt123435'}, 'secondaryIdInfos': [{'id': 'SAGETIK 2025-209', 'type': 'OTHER', 'domain': 'Ethics Committee Approval Number from Aksaray University Training and Research Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I (Low Implant Burden)', 'description': 'Patients treated for femoral or periprosthetic fractures using only 1 metallic cerclage wire as an adjunct to primary fixation.', 'interventionNames': ['Procedure: 1 Metallic Cerclage Wiring']}, {'label': 'Group II (Moderate Implant Burden)', 'description': 'Patients treated for femoral or periprosthetic fractures using 2 metallic cerclage wires as an adjunct to primary fixation.', 'interventionNames': ['Procedure: 2 metalic cerclage wire']}, {'label': 'Group III (High Implant Burden)', 'description': 'Patients treated for femoral or periprosthetic fractures using 3 or more (≥3) metallic cerclage wires as an adjunct to primary fixation.', 'interventionNames': ['Procedure: 3 metalic cerclage wire']}], 'interventions': [{'name': '1 Metallic Cerclage Wiring', 'type': 'PROCEDURE', 'description': 'Application of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in complex femoral fractures', 'armGroupLabels': ['Group I (Low Implant Burden)']}, {'name': '2 metalic cerclage wire', 'type': 'PROCEDURE', 'description': 'Application of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in femoral shaft, subtrochanteric, or periprosthetic fractures', 'armGroupLabels': ['Group II (Moderate Implant Burden)']}, {'name': '3 metalic cerclage wire', 'type': 'PROCEDURE', 'description': 'Patients receiving three or more (≥3) metallic wire or cable loops.', 'armGroupLabels': ['Group III (High Implant Burden)']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available immediately following publication', 'ipdSharing': 'YES', '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', 'accessCriteria': 'Data are available within the manuscript and its supplementary materials for any researcher wishing to use the data for non-commercial purposes'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aksaray University Training and Research Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yasar Samet Gokceoglu', 'investigatorAffiliation': 'Sanliurfa Mehmet Akif Inan Education and Research Hospital'}}}}