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

April 10, 2026 updated by: Yadong Zhang, Hanzhong Central Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Hanzhong, Shaanxi, China, 723000
        • Hanzhong Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical time
Time Frame: "From enrollment to the end of treatment at 6 weeks"
"From enrollment to the end of treatment at 6 weeks"
Intraoperative bleeding
Time Frame: "From enrollment to the end of treatment at 6 weeks
"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
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
From enrollment to the end of treatment at 6 weeks
Success
Time Frame: From enrollment to the end of treatment at 6 weeks
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
"From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanzhong Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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