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OpenTrials
Completed

NCT Number: NCT07534904

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

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.

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Key information

Conditions

Femoral Shaft Fractures and Patellar Fractures Femoral Fractures Fractures, Bone Knee Fractures Knee Injuries Leg Injuries Wounds and Injuries

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hanzhong Central Hospital

Hanzhong, Shaanxi, 723000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Surgical time

    Time frame: "From enrollment to the end of treatment at 6 weeks"

  2. Intraoperative bleeding

    Time frame: "From enrollment to the end of treatment at 6 weeks

  3. Number of C arm fluoroscopies

    Time frame: From enrollment to the end of treatment at 6 weeks

  4. Needle insertion success

    Time frame: From enrollment to the end of treatment at 6 weeks

  5. Success

    Time frame: From enrollment to the end of treatment at 6 weeks

  6. Overall complication rate

    Time frame: "From enrollment to the end of treatment at 6 weeks

Sponsors and collaborators

Lead sponsor

Hanzhong Central Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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