Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Chinese PLA General Hospital
Sponsor:
Information provided by (Responsible Party):
Peifu Tang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01437176
First received: September 1, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Intertrochanteric Fracture
Device: new type of intramedullary nail
Device: The intramedullary nail of PFNA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Bone healing condition [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    Bone healing condition was checked by radiological examination.


Secondary Outcome Measures:
  • Rates of revision Rates of revision surgery [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Patient quality of life [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    SF-36, ADL, Patient quality of life (SF-36, ADL, FIM)

  • Complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    mortality, nonunion, implant breakage/failure, infection, DVT


Estimated Enrollment: 36
Study Start Date: September 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stable intertrochanteric fracture
The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.
Device: new type of intramedullary nail
This is a new fixation treat for intertrochanteric fracture.
Other Names:
  • WEIGAO ORTHOPAEDIC DEVICE CO.LTD.
  • ZL201020121021.6
Device: The intramedullary nail of PFNA
It was used very common in treat with intertrochanteric fracture.
Other Names:
  • AO Foundation
  • PFNA(proximal femoral nail antirotation)
Experimental: Unstable intertrochanteric fracture
The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.
Device: new type of intramedullary nail
This is a new fixation treat for intertrochanteric fracture.
Other Names:
  • WEIGAO ORTHOPAEDIC DEVICE CO.LTD.
  • ZL201020121021.6
Device: The intramedullary nail of PFNA
It was used very common in treat with intertrochanteric fracture.
Other Names:
  • AO Foundation
  • PFNA(proximal femoral nail antirotation)

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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437176

Contacts
Contact: Tang Peifu, Dr. 861099638101 pftang301@126.com
Contact: Shen Jing, Dr. 8613718623511 orthjing@yahoo.com

Locations
China, Beijing
Orthopedics department; The General Hospital of the People's Liberation Army Recruiting
Beijing, Beijing, China, 100853
Contact: Tang Peifu, Dr.    861099638101    pftang301@126.com   
Principal Investigator: Zhang li Hai, Dr.         
Sub-Investigator: Shen Jing, Dr.         
Sponsors and Collaborators
Peifu Tang
Investigators
Study Chair: Tang Peifu Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Peifu Tang, Chief, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01437176     History of Changes
Other Study ID Numbers: PLAGH OD 12
Study First Received: September 1, 2011
Last Updated: February 19, 2013
Health Authority: China: Ethics Committee

Keywords provided by Chinese PLA General Hospital:
surgery
fixation
intramedullary nail

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries

ClinicalTrials.gov processed this record on October 16, 2014