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

NCT07534904 | Completed

• 1 other identifier: 2020-031
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Shaft Fractures and Patellar Fractures; Knee Fractures; Femoral Fractures

Outcome Measures

Primary Outcomes (6)

• 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

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanzhong Central Hospital: lead

Study Sites (1)

Hanzhong Central Hospital

Hanzhong, Shaanxi, 723000, China

Location

MeSH Terms

Conditions

Knee Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Knee Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 06 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: August 1, 2025
• Last Updated: April 16, 2026

Record last verified: 2025-10

Locations

CN (1)