NCT07534904

Development and Clinical Evaluation of a Novel Hollow Cusp Fracture Reducer for Femoral Shaft and Patellar Fractures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 142 (actual)
• Sponsor: Hanzhong Central Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoral Shaft Fractures and Patellar Fractures
• Knee Fractures
• Femoral Fractures

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-01-01
• Completion: 2025-08-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: China