Femoral Fractures, Femoral Shaft Fractures and Patellar Fractures, Knee Fractures
Conditions
Brief summary
This study aimed to develop and clinically evaluate a novel hollow cusp fracture reducer for enhancing the precision and efficiency of closed reduction and internal fixation in patients with femoral shaft fractures and patellar fractures. A prospective randomized controlled trial was conducted at Hanzhong Central Hospital between January 2020 and January 2023. A total of 142 patients were randomly assigned to either the experimental group treated with the novel reduction device or the control group undergoing conventional manual reduction. Primary outcome measures included operative time, number of fluoroscopic images, and K-wire insertion success rate. Secondary outcomes consisted of intraoperative blood loss, length of hospital stay, fracture healing time, and postoperative complication rate. Compared with the conventional technique, the novel hollow cusp fracture reducer significantly shortened operative time and reduced the frequency of intraoperative fluoroscopy, while markedly improving the accuracy of K-wire placement. Fracture healing was also accelerated in the device group. Complication rates were comparable or lower in the experimental group. The novel hollow cusp fracture reducer is safe and effective. It improves the accuracy and efficiency of fracture reduction, lowers radiation exposure, and facilitates earlier postoperative recovery. This device demonstrates high clinical value for the minimally invasive treatment of femoral shaft and patellar fractures.
Interventions
None listed
Sponsors
Hanzhong Central Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age \< 60 years. * Acute traumatic femoral shaft fracture or patellar fracture (AO/OTA classification) * Underwent closed reduction and internal fixation within 7 days of injury * Complete clinical and radiological follow-up data.
Exclusion criteria
* Pathological, infected, or tuberculous fracture. * Severe osteoporosis or metabolic bone disease. * Open fractures, multiple fractures, or severe combined injuries. * Severe cardiac, hepatic, renal, or hematological comorbidities. * Patients who declined participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical time | "From enrollment to the end of treatment at 6 weeks" |
| Intraoperative bleeding | "From enrollment to the end of treatment at 6 weeks |
| Number of C arm fluoroscopies | From enrollment to the end of treatment at 6 weeks |
| Needle insertion success | From enrollment to the end of treatment at 6 weeks |
| Success | From enrollment to the end of treatment at 6 weeks |
| Overall complication rate | "From enrollment to the end of treatment at 6 weeks |
Countries
China
Outcome results
None listed