Intertrochanteric FractureNCT01437176
Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail
A study testing new type of intramedullary nail and The intramedullary nail of PFNA in people with Intertrochanteric Fracture, run by Peifu Tang at 1 site in China.
Trial summary
The purpose of this study is to determine whether this new intramedullary fixation is effective in the treatment of intertrochanteric fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intertrochanteric Fracture
- What is being tested?
- new type of intramedullary nail and The intramedullary nail of PFNA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women aged 18 years and older (with no upper age limit).
- Fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Operative treatment of fractures within 14 days of presenting to the emergency room.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- Anticipated medical optimalization for operative fixation of the hip.
- Provision of informed consent by patient or legal guardian.
- No other major trauma.
Who cannot join
- Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected hip.
- Infection around the hip (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
- Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
- Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Orthopedics department; The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853
Tang Peifu, Dr., 861099638101, pftang301@126.com
Zhang li Hai, Dr.
About this study
The purpose of this study is to determine whether this new intramedullary fixation is effective in the treatment of intertrochanteric fracture.
Read the detailed description
With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.
This new type of intramedullary fixation of intertrochanteric fractures of devices, including a proximal femoral anatomy and adapt to proximal femoral nail, proximal femoral nail through the femoral head and distal femur compression screw locking screw, its main features are:
- The proximal femoral nail was made from titanium, its proximal part is narrow inside and wide outside structure. It looks like a trapezoidal in cross-section. This device was matched with the anatomy of proximal femur and its mechanical reliability.
- The tip of compression screw was designed thread. It can come through the intramedullary nail, produce slide and sustained pressure.
- The femoral support screw was made in cylindrical, had a blunt rounded tip. The tip of the femoral support screw was tabling with the groove of compression screw. This design can support interior mechanical stability. At the same time, the support screw from the femoral head and neck compression screw can slide fine-tuning, so it has a direct offset against varus and femoral neck rotating shift to prevent secondary loss of fracture reduction. The screw in the femoral head also can prevent cutting occurs.
- This device can be used in minimally invasive approach of percutaneous and implanted in body. Reduce reduction time, fracture interference and help the natural healing of fractures.
- Conditions
- Intertrochanteric Fracture
- Being tested
- new type of intramedullary nail, The intramedullary nail of PFNA
- Keywords
- surgery, fixation, intramedullary nail
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new type of intramedullary nailDevice
Also called WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL201020121021.6
This is a new fixation treat for intertrochanteric fracture.
The intramedullary nail of PFNADevice
Also called AO Foundation, PFNA(proximal femoral nail antirotation)
It was used very common in treat with intertrochanteric fracture.
| Study group | Role | What they receive |
|---|---|---|
| Unstable intertrochanteric fracture fixed with novel nail | Experimental | AO/OTA A2 fracture fixed with novel nail Receives: Device: new type of intramedullary nail |
| unstable intertrochanteric fracture fixed with PFNA | Experimental | AO/OTA A2 fracture fixed with PFNA Receives: Device: The intramedullary nail of PFNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative quality of life score
SF-36 PCS
Measured: preoperative, six months and one year postoperative
Secondary outcomes (9)
rate of fracture healing at three months
fracture healing condition was checked by radiological examination.
Measured: three months postoperative
rate of femoral medialization
femoral medialization
Measured: one year postoperative
collodiaphyseal angle
collodiaphyseal angle
Measured: one year postoperative
weight bearing
time of weight bearing
Measured: perioperation
rate of patient satisfaction with treatment
1-year VAS satisfaction
Measured: one year postoperative
Hip function score
OHS
Measured: preoperative, six months and one year postoperative
time of surgical during
The time from the beginning to the end of the surgery
Measured: Perioperative
fluoroscopy time
Duration of fluoroscopy
Measured: intraoperative
rate of complications related to implant
cut out, nonunion, implant breakage/failure, infection
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2022
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intertrochanteric FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peifu Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peifu Tang, Chinese PLA General Hospital
- Investigators
- Tang Peifu, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437176
- Sponsor's protocol ID
- PLAGH OD 12
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2011
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Nie S, Li J, Liu X, Liu J, Wu X, Tang P, Zhao Y, Li M, Zhang L. The clinical efficacy of Medial Sustain Nail(MSN) and Proximal femoral nail anti-rotation(PFNA) for fixation of medial comminuted trochanteric fractures: a prospective randomized controlled trial. Int Orthop. 2024 Aug;48(8):2189-2200. doi: 10.1007/s00264-024-06220-6. Epub 2024 May 21.
PubMed 38772935
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail
- ClinicalTrials.gov ID
- NCT01437176
- Acronym / sponsor ID
- PLAGH OD 12
- Conditions
- Intertrochanteric Fracture
- Keywords
- surgery, fixation, intramedullary nail
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peifu TangUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2022 (actual)
- Study completion
- Aug 2024 (estimated)
- First posted
- 20 Sep 2011 (estimated)
- 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.
The purpose of this study is to determine whether this new intramedullary fixation is effective in the treatment of intertrochanteric fracture.
Detailed description
With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.
This new type of intramedullary fixation of intertrochanteric fractures of devices, including a proximal femoral anatomy and adapt to proximal femoral nail, proximal femoral nail through the femoral head and distal femur compression screw locking screw, its main features are:
- The proximal femoral nail was made from titanium, its proximal part is narrow inside and wide outside structure. It looks like a trapezoidal in cross-section. This device was matched with the anatomy of proximal femur and its mechanical reliability.
- The tip of compression screw was designed thread. It can come through the intramedullary nail, produce slide and sustained pressure.
- The femoral support screw was made in cylindrical, had a blunt rounded tip. The tip of the femoral support screw was tabling with the groove of compression screw. This design can support interior mechanical stability. At the same time, the support screw from the femoral head and neck compression screw can slide fine-tuning, so it has a direct offset against varus and femoral neck rotating shift to prevent secondary loss of fracture reduction. The screw in the femoral head also can prevent cutting occurs.
- This device can be used in minimally invasive approach of percutaneous and implanted in body. Reduce reduction time, fracture interference and help the natural healing of fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unstable intertrochanteric fracture fixed with novel nail | Experimental | Device: new type of intramedullary nailAO/OTA A2 fracture fixed with novel nail |
| unstable intertrochanteric fracture fixed with PFNA | Experimental | Device: The intramedullary nail of PFNAAO/OTA A2 fracture fixed with PFNA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men or women aged 18 years and older (with no upper age limit).
- Fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Operative treatment of fractures within 14 days of presenting to the emergency room.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- Anticipated medical optimalization for operative fixation of the hip.
Key exclusion criteria (8 listed)
- Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected hip.
- Infection around the hip (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
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 |
|---|---|---|
| new type of intramedullary nailAlso: WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL201020121021.6This is a new fixation treat for intertrochanteric fracture. | Device | Unstable intertrochanteric fracture fixed with novel nail |
| The intramedullary nail of PFNAAlso: AO Foundation, PFNA(proximal femoral nail antirotation)It was used very common in treat with intertrochanteric fracture. | Device | unstable intertrochanteric fracture fixed with PFNA |
Primary outcome
Postoperative quality of life score
Time frame: preoperative, six months and one year postoperative
SF-36 PCS
9 secondary outcomes
rate of fracture healing at three months
Time frame: three months postoperative
rate of femoral medialization
Time frame: one year postoperative
collodiaphyseal angle
Time frame: one year postoperative
weight bearing
Time frame: perioperation
rate of patient satisfaction with treatment
Time frame: one year postoperative
Hip function score
Time frame: preoperative, six months and one year postoperative
time of surgical during
Time frame: Perioperative
fluoroscopy time
Time frame: intraoperative
rate of complications related to implant
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 38772935Nie S, Li J, Liu X, Liu J, Wu X, Tang P, Zhao Y, Li M, Zhang L. The clinical efficacy of Medial Sustain Nail(MSN) and Proximal femoral nail anti-rotation(PFNA) for fixation of medial comminuted trochanteric fractures: a prospective randomized controlled trial. Int Orthop. 2024 Aug;48(8):2189-2200. doi: 10.1007/s00264-024-06220-6. Epub 2024 May 21.
Related trials for Intertrochanteric Fracture
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
RecruitingObservational study
Cohort Study on the Prognosis and Influencing Factors in Elderly Patients With Hip Fractures in Multicenter of China
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Recruiting
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Hip Fracture of Intertrochanteric Type
Not yet recruiting
FICB for Hip Fracture Pain in Elderly
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures
Intertrochanteric Fractures, Intertrochanteric Fractures of the Hip
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.
Tang Peifu study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new type of intramedullary nail and The intramedullary nail of PFNA in people with Intertrochanteric Fracture, run by Peifu Tang 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 8 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 21 Sep 2022. 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 Tang Peifu, Dr. (861099638101, pftang301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative quality of life score (time frame: preoperative, six months and one year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01437176, which also lists 1 linked publication.
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 21 Sep 2022.