Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail
NCT ID: NCT01437176
Last Updated: 2022-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2011-09-30
2024-08-31
Brief Summary
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Detailed Description
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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:
1. 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.
2. The tip of compression screw was designed thread. It can come through the intramedullary nail, produce slide and sustained pressure.
3. 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.
4. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Unstable intertrochanteric fracture fixed with novel nail
AO/OTA A2 fracture fixed with novel nail
new type of intramedullary nail
This is a new fixation treat for intertrochanteric fracture.
unstable intertrochanteric fracture fixed with PFNA
AO/OTA A2 fracture fixed with PFNA
The intramedullary nail of PFNA
It was used very common in treat with intertrochanteric fracture.
Interventions
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new type of intramedullary nail
This is a new fixation treat for intertrochanteric fracture.
The intramedullary nail of PFNA
It was used very common in treat with intertrochanteric fracture.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Peifu Tang
OTHER
Responsible Party
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Peifu Tang
Chief, Professor
Principal Investigators
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Tang Peifu
Role: STUDY_CHAIR
Chinese PLA General Hospital
Locations
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Orthopedics department; The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PLAGH OD 12
Identifier Type: -
Identifier Source: org_study_id
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