Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail

NCT ID: NCT01437176

Last Updated: 2022-09-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2024-08-31

Brief Summary

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The purpose of this study is to determine whether this new intramedullary fixation is effective in the treatment of intertrochanteric fracture.

Detailed Description

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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:

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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Intertrochanteric Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Unstable intertrochanteric fracture fixed with novel nail

AO/OTA A2 fracture fixed with novel nail

Group Type EXPERIMENTAL

new type of intramedullary nail

Intervention Type DEVICE

This is a new fixation treat for intertrochanteric fracture.

unstable intertrochanteric fracture fixed with PFNA

AO/OTA A2 fracture fixed with PFNA

Group Type EXPERIMENTAL

The intramedullary nail of PFNA

Intervention Type DEVICE

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.

Intervention Type DEVICE

The intramedullary nail of PFNA

It was used very common in treat with intertrochanteric fracture.

Intervention Type DEVICE

Other Intervention Names

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WEIGAO ORTHOPAEDIC DEVICE CO.LTD. ZL201020121021.6 AO Foundation PFNA(proximal femoral nail antirotation)

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peifu Tang

OTHER

Sponsor Role lead

Responsible Party

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Peifu Tang

Chief, Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Tang Peifu, Dr.

Role: CONTACT

861099638101

Shen Jing, Dr.

Role: CONTACT

8613718623511

Facility Contacts

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Tang Peifu, Dr.

Role: primary

861099638101

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.

Reference Type DERIVED
PMID: 38772935 (View on PubMed)

Other Identifiers

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PLAGH OD 12

Identifier Type: -

Identifier Source: org_study_id

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