An observational study in Femoral Shaft Fractures and Patellar Fractures, Knee Fractures and Femoral Fractures, sponsored by Hanzhong Central Hospital. Completed at 1 site in China. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Hanzhong Central Hospital · Observational
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.
293 studies on the registry are indexed under Femoral Fractures; 47 are open to participants now.
This study's enrollment of 142 is above the median of 100 across 96 observational studies indexed under Femoral Fractures.
Browse Femoral Fractures studies →This is the only study on the registry with Hanzhong Central Hospital as lead sponsor.
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A total of 142 patients were included, with 71 patients in each group. Baseline characteristics, including age, sex, BMI, fracture type, injury mechanism, and time from injury to surgery, were well balanced between groups (P > 0.05).
Exclusion Criteria:
Surgical time
Time frame: "From enrollment to the end of treatment at 6 weeks"
Intraoperative bleeding
Time frame: "From enrollment to the end of treatment at 6 weeks
Number of C arm fluoroscopies
Time frame: From enrollment to the end of treatment at 6 weeks
Needle insertion success
Time frame: From enrollment to the end of treatment at 6 weeks
Success
Time frame: From enrollment to the end of treatment at 6 weeks
Overall complication rate
Time frame: "From enrollment to the end of treatment at 6 weeks
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Knee Fractures