Femur FractureC-INFECTNCT07434258
Dose-Response Association Between Cerclage Wire Number and Infection Risk
An observational study of Femur Fracture and Periprosthetic Fracture of Hip, run by Istanbul University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture, Periprosthetic Fracture of Hip, Periprosthetic Fracture of the Femur
- What is being tested?
- 1 Metallic Cerclage Wiring, 2 metalic cerclage wire and 3 metalic cerclage wire
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2015to 10 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Femur Fracture, Periprosthetic Fracture of Hip, Periprosthetic Fracture of the Femur, Surgical Site Infection (SSI), Biofilms, Postoperative Complications
- Being tested
- 1 Metallic Cerclage Wiring, 2 metalic cerclage wire, 3 metalic cerclage wire
- Keywords
- Cerclage Wire, Implant Burden, Persistent Wound Drainage, Dose-Response Relationship, Orthopedic Fixation Devices, Subtrochanteric Fractures, Biofilm Formation
- Medical subject headings
- Femoral Fractures, Surgical Wound Infection, Postoperative Complications, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Metallic Cerclage WiringProcedure or surgery
Application of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in complex femoral fractures
2 metalic cerclage wireProcedure or surgery
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 wireProcedure or surgery
Patients receiving three or more (≥3) metallic wire or cable loops.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Low Implant Burden) | Patients treated for femoral or periprosthetic fractures using only 1 metallic cerclage wire as an adjunct to primary fixation. Receives: 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. Receives: 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. Receives: Procedure: 3 metalic cerclage wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Evaluation of inflammatory kinetics through serum C-reactive protein (CRP) levels to detect delayed washout or secondary peaks.
Measured: Assessed at 14 days following the date of surgery
Operative Duration
Total surgical time in minutes as a measure of perioperative surgical burden.
Measured: From the start of the surgery until the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start10 Apr 2015
- Primary completion20 Jan 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Aksaray University Training and Research Hospital
- Responsible party
- Principal investigator, Yasar Samet Gokceoglu, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434258
- Sponsor's protocol ID
- ysrsmt123435
- Other IDs
- SAGETIK 2025-209
- Acronym
- C-INFECT
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 17699815Kim 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.
PubMed 25230266Apivatthakakul 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.
PubMed 23164676Baumgaertner 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.
PubMed 7608228Parvizi 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.
PubMed 21938532Parvizi 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.
PubMed 29551303Cichos 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(9 Suppl 2):S469-S475.e1. doi: 10.1016/j.arth.2024.04.042. Epub 2024 Apr 18.
PubMed 38642854Lenz 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.
PubMed 23142812Perren 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.
PubMed 26787178Almeida 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.
PubMed 34760287Moore 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.
PubMed 35336161Ziegenhain 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.
PubMed 40392364Kook 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.
PubMed 38098139Kim 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.
PubMed 35618854Hantouly 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.
PubMed 35377073
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Association Between Cerclage Construct Count and Deep Infection After Femoral and Periprosthetic Femoral Fracture Fixation: A Dual-Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07434258
- Acronym / sponsor ID
- C-INFECT / ysrsmt123435
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Aksaray University Training and Research Hospital
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Low Implant Burden) | – | Procedure: 1 Metallic Cerclage WiringPatients treated for femoral or periprosthetic fractures using only 1 metallic cerclage wire as an adjunct to primary fixation. |
| Group II (Moderate Implant Burden) | – | Procedure: 2 metalic cerclage wirePatients treated for femoral or periprosthetic fractures using 2 metallic cerclage wires as an adjunct to primary fixation. |
| Group III (High Implant Burden) | – | Procedure: 3 metalic cerclage wirePatients treated for femoral or periprosthetic fractures using 3 or more (≥3) metallic cerclage wires as an adjunct to primary fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Metallic Cerclage WiringApplication of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in complex femoral fractures | Procedure or surgery | Group I (Low Implant Burden) |
| 2 metalic cerclage wireApplication of circumferential metallic wires or braided cables to achieve anatomical reduction and neutralize shear forces in femoral shaft, subtrochanteric, or periprosthetic fractures | Procedure or surgery | Group II (Moderate Implant Burden) |
| 3 metalic cerclage wirePatients receiving three or more (≥3) metallic wire or cable loops. | Procedure or surgery | Group III (High Implant Burden) |
Primary outcome
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.
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
2 secondary outcomes
CRP Level at Postoperative Day 14
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 17699815Trampuz 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.
- Background: PubMed 25230266Kim 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.
- Background: PubMed 23164676Apivatthakakul 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.
- Background: PubMed 7608228Baumgaertner 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.
- Background: PubMed 21938532Parvizi 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.
- Background: PubMed 29551303Parvizi 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.
- Background: PubMed 38642854Cichos 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(9 Suppl 2):S469-S475.e1. doi: 10.1016/j.arth.2024.04.042. Epub 2024 Apr 18.
- Background: PubMed 23142812Lenz 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.
- Background: PubMed 26787178Perren 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.
- Background: PubMed 34760287Almeida 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.
- Background: PubMed 35336161Moore 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.
- Background: PubMed 40392364Ziegenhain 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture and Periprosthetic Fracture of Hip, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07434258, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.