Femoral Shaft Fractures and Patellar FracturesNCT07534904
Development and Clinical Evaluation of a Novel Hollow Cusp Fracture Reducer for Femoral Shaft and Patellar Fractures
An observational study of Femoral Shaft Fractures and Patellar Fractures and Knee Fractures, run by Hanzhong Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Femoral Shaft Fractures and Patellar Fractures, Knee Fractures, Femoral Fractures
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Aug 2025
- How long will I take part?
- 06 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Knee Fractures, Femoral Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
Measured: "From enrollment to the end of treatment at 6 weeks"
Intraoperative bleeding
Measured: "From enrollment to the end of treatment at 6 weeks
Number of C arm fluoroscopies
Measured: From enrollment to the end of treatment at 6 weeks
Needle insertion success
Measured: From enrollment to the end of treatment at 6 weeks
Success
Measured: From enrollment to the end of treatment at 6 weeks
Overall complication rate
Measured: "From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jan 2020
- Primary completion1 Jan 2023
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Shaft Fractures and Patellar FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 142 participants (actual)
- Target duration
- 06 Weeks
Sponsor and investigators
- Lead sponsor
- Hanzhong Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yadong Zhang, Hanzhong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534904
- Sponsor's protocol ID
- 2020-031
- Status last verified
- Oct 2025
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Evaluation of a Novel Hollow Cusp Fracture Reducer for Femoral Shaft and Patellar Fractures
- ClinicalTrials.gov ID
- NCT07534904
- Acronym / sponsor ID
- 2020-031
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hanzhong Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 06 Weeks
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Shaft Fractures and Patellar Fractures and Knee Fractures, run by Hanzhong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical time (time frame: "From enrollment to the end of treatment at 6 weeks"). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.