Cerclage Fixation of Third Fragment in Femoral Shaft Fracture is That Necessary
Femoral Shaft Fracture
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 42 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
The aim of this study is to compare closed reduction and intramedullary nailing with open reduction, cerclage fixation of the third fragment and intramedullary nailing in femoral shaft fractures with a third fragment, regarding radiographic healing, operative time, intraoperative blood loss and postoperative complications, and to explore third-fragment characteristics associated with impaired healing.
Read the full description
The aim of this study is to compare closed reduction and intramedullary nailing with open reduction, cerclage fixation of the third fragment and intramedullary nailing in skeletally mature patients with femoral shaft fractures containing a third (wedge or butterfly) fragment. Written informed consent was obtained from every patient before enrolment.
Patients were randomly allocated in a 1:1 ratio using a computer-generated sequence with permuted blocks, concealed in sequentially numbered sealed opaque envelopes opened in the operating theatre after enrolment and anaesthesia. Blinding of surgeons was not possible because the two techniques differ visibly.
Group 1 (Closed group) (21 cases): reduction was performed without opening the fracture site, followed by antegrade or retrograde intramedullary nailing.
Group 2 (Open group) (21 cases): the fracture site was exposed, the third fragment was reduced with a bone clamp and stabilized with cerclage wiring, followed by antegrade or retrograde intramedullary nailing.
Preoperative radiographs and, when available, computed tomography were used to measure third-fragment length, width, projected area and displacement. Follow-up radiographs were obtained at approximately six weeks, three months, six months and nine months. Healing was assessed using the Radiographic Union Score for Femur (RUSF) by two independent reviewers. Union was defined as bridging callus across at least three of four cortices with painless full weight bearing, delayed union as failure to achieve union by six months, and nonunion as failure to achieve union by nine months. Operative time, intraoperative blood loss, infection and other postoperative complications were recorded.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Skeletally mature patients
- Recent femoral shaft fracture (within six weeks of injury) without radiographic signs of established union
- Femoral shaft fracture (from 5 cm distal to the lesser trochanter to 9 cm proximal to the knee joint line) with a separate wedge (third) fragment of at least 1 cm(Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association \[AO/OTA\] type 32-B)
- Fractures with subtrochanteric or supracondylar extension were eligible
Exclusion Criteria:
- Simple fractures
- Skeletal immaturity
- Revision procedures
- Peri-implant fractures
- Gustilo type III open fractures
- Pathological fractures
- Inability or unwillingness to attend follow-up at the study centre
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Closed reduction group
Procedure: closed reduction and intramedullary nailing. The fracture is reduced without opening the fracture site, followed by antegrade or retrograde intramedullary nailing; the third fragment is not directly fixed.
Procedure: Closed reduction and intramedullary nailing
Open reduction and cerclage group
Procedure: open reduction, cerclage fixation and intramedullary nailing. The fracture site is exposed, the third fragment is reduced with a bone clamp and stabilized with cerclage wiring, followed by antegrade or retrograde intramedullary nailing.
Procedure: Open reduction, cerclage fixation and intramedullary nailing
Closed reduction and intramedullary nailing PROCEDURE
Closed reduction without exposure of the fracture site, followed by antegrade or retrograde intramedullary nailing.
Open reduction, cerclage fixation and intramedullary nailing PROCEDURE
Open exposure of the fracture site with reduction and cerclage wiring of the third fragment, followed by antegrade or retrograde intramedullary nailing.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Radiographic union rate at six months
Time frame: 6 months postoperatively
Proportion of patients with radiographic union, defined as bridging callus across at least three of four cortices on anteroposterior and lateral radiographs with painless full weight bearing, assessed using the Radiographic Union Score for Femur (RUSF) by two independent reviewers.
Secondary measures
Delayed union rate
Time frame: 6 months postoperatively
Proportion of patients who failed to achieve radiographic union by six months.
Nonunion rate
Time frame: 9 months postoperatively
Proportion of patients who failed to achieve radiographic union by nine months
Operative time
Time frame: Intraoperative
Duration of surgery from skin incision to wound closure, in minutes.
Intraoperative blood loss
Time frame: Intraoperative
Estimated intraoperative blood loss, in millilitres.
Postoperative complications
Time frame: Up to 9 months postoperatively
Number of patients with postoperative complications, including surgical site infection.
Discriminative ability of third-fragment projected area for delayed union
Time frame: 9 months postoperatively
Third-fragment projected area (cm²), measured on preoperative imaging, evaluated for its ability to discriminate delayed union using receiver-operating-characteristic analysis, reported as the area under the curve (AUC).
Discriminative ability of third-fragment length for nonunion
Time frame: 9 months postoperatively
Third-fragment length (cm), measured on preoperative imaging, evaluated for its ability to discriminate nonunion using receiver-operating-characteristic analysis, reported as the area under the curve (AUC).
Discriminative ability of third-fragment displacement for nonunion
Time frame: 9 months postoperatively
Third-fragment displacement (mm), measured on preoperative imaging, evaluated for its ability to discriminate nonunion using receiver-operating-characteristic analysis, reported as the area under the curve (AUC).
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Ain Shams University
- Study start
- Dec 1, 2022 Actual
- Primary completion
- Dec 1, 2025 Actual
- Study completion
- Dec 1, 2025 Actual
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Cerclage Fixation of Third Fragment in Femoral Shaft Fracture is That Necessary
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026