Femoral Intertrochanteric FracturesNCT06277622
A Prospective Multicenter Cohort Study About Internal Fixation Using PFUN Versus PFNA for Femoral Intertrochanteric Fracture
A study testing PFUN and PFNA in people with Femoral Intertrochanteric Fractures, run by Peking University Third Hospital at 1 site in China.
Trial summary
This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Femoral Intertrochanteric Fractures
- What is being tested?
- PFUN and PFNA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients with unilateral femoral intertrochanteric fractures that will be treated with internal fixation
- According to AO fracture classification, subjects with the fracture type (31-A)
- Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
- Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor.
- The investigator believes that the subject can understand the clinical study, is willing and able to complete all research procedures and followup visits and can cooperate with the research procedures.
- In-label use of the PFUN and PFNA.
Who cannot join
- Subject does not provide voluntary consent to participate in the study.
- The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.)
- The subjects were pregnant or lactating women.
- The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
- Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).
- Concurrent hip osteoarthritis.
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- Fractures where the operative treatment will occur more than three weeks after the primary injury
- Patients combined with other bone fractures.
- Pathological fracture (e.g., primary or metastatic tumor)
- Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined open fractures, vascular injury, and combined osteofascial compartment syndrome
- Multiple systemic injuries judged by researchers not suitable for enrollment.
- Revision surgeries (for example, due to malunion, nonunion or infection)
- Concurrent medical conditions judged by researchers not suitable for enrollment, such as: metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc
- Patients with anaesthetic and surgical contraindications
- Patients known to be allergic to implant components
- Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months)
- Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
- Subjects participated in other clinical studies in the past 3 months, which may affect the outcome and follow-up according to the judgment of researchers.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yuan Cao, MD, +86-01082266699, cy6415@126.com
Fang Zhou, MD, +86010-82267010, zhouf@bjmu.edu.cn
About this study
Official title: A Prospective Multicenter Cohort Study About Internal Fixation Using Proximal Femoral Universal Nail (PFUN) Versus Proximal Femoral Nail Antirotation (PFNA) for Femoral Intertrochanteric Fracture
This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture.
Read the detailed description
This is a prospective multicenter cohort study. The team leader is Peking University Third Hospital. All patients are divided into 2 groups according to the internal fixation they choose. Investigators use PFUN for internal fixation in Group 1 and PFNA in Group 2. The relevant parameters of the sample calculation are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample size was 130. The PFUN group and the PFNA group each included 65 patients. See the text for detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but do not meet any exclusion criteria, and who have signed the informed consent will be recruited, and each patient will be assigned a unique patient identification number, which will be used throughout the study identify the patient. Investigators will perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. Investigators only plan to include cases that can successfully conduct closed reduction, therefore investigators will exclude cases that require open reduction. After the operation, the patients will be managed according to the standard nursing and rehabilitation procedures of the experimental site and the results of laboratory tests will be recorded. Regular follow-up evaluation will be performed after the operation until the end of the 21-month follow-up or the primary end point of the study. In this study, the internal fixation failure rate (IFFR) is used as the primary end point of the study, which is defined as the total incidence of internal plant cut-out and fracture. The results of the radiographic examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an independent radiologist to determine whether there are cut-out or fracture of the internal plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, it is defined as nonunion if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months. 2. Garden classification proportion, and Garden index for reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The times of intraoperative fluoroscopy, average 25 milliseconds per Xray shot, record the number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening. In this study, it is difficult to blind anyone . Investigators will try their best to reduce human-induced bias in experimental results. Investigators will use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value <0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL, USA) will be used to analyze the results
- Conditions
- Femoral Intertrochanteric Fractures
- Being tested
- PFUN, PFNA
- Keywords
- Femoral Intertrochanteric Fractures, internal fixation, PFUN and PFNA, multicenter randomized controlled clinical trial, internal fixation failure rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFUNDevice
perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.
PFNADevice
perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging.
| Study group | Role | What they receive |
|---|---|---|
| Proximal Femoral Universal Nail (PFUN) | Experimental | Not described Receives: Device: PFUN |
| Proximal Femoral Nail Antirotation (PFNA) | Active comparator | Not described Receives: Device: PFNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal fixation failure rate
defined as the total incidence of internal plant cut-out and fracture.
Measured: from operation to 21-month follow-up after the surgery
Secondary outcomes (5)
Number of Participants with Bone nonunion
evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months, it is defined as nonunion.
Measured: from operation to 21-month follow-up after the surgery
Harris hip score
the score value is from 0 to 100, and a higher score means a better outcome
Measured: from operation to 21-month follow-up after the surgery
operation time
from the incision to internal fixation implanted.
Measured: intraoperative
The times of intraoperative fluoroscopy
average 25 milliseconds per X-ray shot, record the number of X-ray shot
Measured: intraoperative
Number of Participants with Postoperative adverse events
including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening
Measured: from operation to 21-month follow-up after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jan 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Intertrochanteric 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up.The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Yanqing Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277622
- Sponsor's protocol ID
- PekingUTH ZFCY PFUN
- Status last verified
- Jan 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study About Internal Fixation Using Proximal Femoral Universal Nail (PFUN) Versus Proximal Femoral Nail Antirotation (PFNA) for Femoral Intertrochanteric Fracture
- ClinicalTrials.gov ID
- NCT06277622
- Acronym / sponsor ID
- PekingUTH ZFCY PFUN
- Conditions
- Femoral Intertrochanteric Fractures
- Keywords
- Femoral Intertrochanteric Fractures, internal fixation, PFUN and PFNA, multicenter randomized controlled clinical trial, internal fixation failure rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Yanqing Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Feb 2024 (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 prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up. The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose. The internal fixation failure rate (IFFR) and differences in fracture prognosis of the two groups will be compared. Obtain clinical data of PFUN in the Chinese population, and verify the safety and efficacy of PFUN for patients with femoral intertrochanteric fracture.
Detailed description
This is a prospective multicenter cohort study. The team leader is Peking University Third Hospital. All patients are divided into 2 groups according to the internal fixation they choose. Investigators use PFUN for internal fixation in Group 1 and PFNA in Group 2. The relevant parameters of the sample calculation are α = 0.05 (one-sided) and β = 0.2. PASS 15 was used for calculation, and the final sample size was 130. The PFUN group and the PFNA group each included 65 patients. See the text for detailed inclusion and exclusion criteria. Patients that meet all the inclusion criteria but do not meet any exclusion criteria, and who have signed the informed consent will be recruited, and each patient will be assigned a unique patient identification number, which will be used throughout the study identify the patient. Investigators will perform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. Investigators only plan to include cases that can successfully conduct closed reduction, therefore investigators will exclude cases that require open reduction. After the operation, the patients will be managed according to the standard nursing and rehabilitation procedures of the experimental site and the results of laboratory tests will be recorded. Regular follow-up evaluation will be performed after the operation until the end of the 21-month follow-up or the primary end point of the study. In this study, the internal fixation failure rate (IFFR) is used as the primary end point of the study, which is defined as the total incidence of internal plant cut-out and fracture. The results of the radiographic examination, the lateral X-ray film and computed tomography(CT), will be evaluated by an independent radiologist to determine whether there are cut-out or fracture of the internal plant. Secondary endpoints include: 1. Bone nonunion after 36 weeks: evaluate bone healing according to the lateral X-ray examination. According to the regulations of Food and Drug Administration of the US, it is defined as nonunion if there are no obvious signs of fracture healing 9 months after the fracture, or if there is no obvious difference in fracture space after three consecutive months. 2. Garden classification proportion, and Garden index for reduction assessment. 3. Clinical prognosis: o A 12-Item Short-Form Health Survey (SF-12) o Harris hip score. 4. Operation time, from the incision to internal fixation implanted. 5. The times of intraoperative fluoroscopy, average 25 milliseconds per Xray shot, record the number of X-ray shot. 6. Postoperative adverse events within 2 years, including ipsilateral femoral head avascular necrosis, infection, wound hematoma, ipsilateral coxa vara, and ipsilateral limb shortening. In this study, it is difficult to blind anyone . Investigators will try their best to reduce human-induced bias in experimental results. Investigators will use one-sided α = 0.05 for statistical tests and confidence interval calculations. P value <0.05 is considered statistically significant. SPSS (latest version: SPSS Inc., Chicago, IL, USA) will be used to analyze the results
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective multicenter cohort study is to compare the post-operative implant failure rate between the patients with femoral intertrochanteric fracture (AO classification 31-A) using Proximal Femoral Universal Nail (PFUN) versus Proximal Femoral Nail Antirotation (PFNA) at 21-month follow up.The patients are divided into the PFUN group and the PFNA group according to the internal fixation they choose.
| Arm | Type | Receives |
|---|---|---|
| Proximal Femoral Universal Nail (PFUN) | Experimental | Device: PFUN |
| Proximal Femoral Nail Antirotation (PFNA) | Active comparator | Device: PFNA |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Patients with unilateral femoral intertrochanteric fractures that will be treated with internal fixation
- According to AO fracture classification, subjects with the fracture type (31-A)
- Subjects (with the help of relatives) can understand the informed documents and patient questionnaires.
- Subjects (with the help of relatives) voluntarily provide written informed consent to participate in the clinical study and authorize the transfer of their information to the sponsor.
Key exclusion criteria (18 listed)
- Subject does not provide voluntary consent to participate in the study.
- The researcher believes that the subjects have conditions that affect the participation and follow-up of this study. (for example, the patient lives in a remote area or has difficulty in going back to the hospital for follow-up or does not cooperate with the medical guidance and suggestions of the surgeon.)
- The subjects were pregnant or lactating women.
- The researchers believe that the subjects have psychological disorders, which may affect the treatment outcome.
- Subjects have significant neurological or musculoskeletal disorders or may have adverse effects on gait or weight-bearing (e.g., muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot arthropathy, avascular necrosis of the femoral head).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFUNperform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. | Device | Proximal Femoral Universal Nail (PFUN) |
| PFNAperform preoperative preparation, intraoperative operation and internal fixation implantation according to the instructions provided in the product packaging. | Device | Proximal Femoral Nail Antirotation (PFNA) |
Primary outcome
Internal fixation failure rate
Time frame: from operation to 21-month follow-up after the surgery
defined as the total incidence of internal plant cut-out and fracture.
5 secondary outcomes
Number of Participants with Bone nonunion
Time frame: from operation to 21-month follow-up after the surgery
Harris hip score
Time frame: from operation to 21-month follow-up after the surgery
operation time
Time frame: intraoperative
The times of intraoperative fluoroscopy
Time frame: intraoperative
Number of Participants with Postoperative adverse events
Time frame: from operation to 21-month follow-up after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFUN and PFNA in people with Femoral Intertrochanteric Fractures, run by Peking University Third 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 7 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Cao, MD (+86010-82266699, cy6415@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal fixation failure rate (time frame: from operation to 21-month follow-up after the surgery). 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 26 Feb 2024.