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Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail

Primary Purpose

Intertrochanteric Fracture

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
new type of intramedullary nail
The intramedullary nail of PFNA
Sponsored by
Peifu Tang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intertrochanteric Fracture focused on measuring surgery, fixation, intramedullary nail

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedics department; The General Hospital of the People's Liberation ArmyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Unstable intertrochanteric fracture fixed with novel nail

unstable intertrochanteric fracture fixed with PFNA

Arm Description

AO/OTA A2 fracture fixed with novel nail

AO/OTA A2 fracture fixed with PFNA

Outcomes

Primary Outcome Measures

Postoperative quality of life score
SF-36 PCS

Secondary Outcome Measures

rate of fracture healing at three months
fracture healing condition was checked by radiological examination.
rate of femoral medialization
femoral medialization
collodiaphyseal angle
collodiaphyseal angle
weight bearing
time of weight bearing
rate of patient satisfaction with treatment
1-year VAS satisfaction
Hip function score
OHS
time of surgical during
The time from the beginning to the end of the surgery
fluoroscopy time
Duration of fluoroscopy
rate of complications related to implant
cut out, nonunion, implant breakage/failure, infection

Full Information

First Posted
September 1, 2011
Last Updated
September 17, 2022
Sponsor
Peifu Tang
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1. Study Identification

Unique Protocol Identification Number
NCT01437176
Brief Title
Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail
Official Title
Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2022 (Actual)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peifu Tang

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrochanteric Fracture
Keywords
surgery, fixation, intramedullary nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unstable intertrochanteric fracture fixed with novel nail
Arm Type
Experimental
Arm Description
AO/OTA A2 fracture fixed with novel nail
Arm Title
unstable intertrochanteric fracture fixed with PFNA
Arm Type
Experimental
Arm Description
AO/OTA A2 fracture fixed with PFNA
Intervention Type
Device
Intervention Name(s)
new type of intramedullary nail
Other Intervention Name(s)
WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL201020121021.6
Intervention Description
This is a new fixation treat for intertrochanteric fracture.
Intervention Type
Device
Intervention Name(s)
The intramedullary nail of PFNA
Other Intervention Name(s)
AO Foundation, PFNA(proximal femoral nail antirotation)
Intervention Description
It was used very common in treat with intertrochanteric fracture.
Primary Outcome Measure Information:
Title
Postoperative quality of life score
Description
SF-36 PCS
Time Frame
preoperative, six months and one year postoperative
Secondary Outcome Measure Information:
Title
rate of fracture healing at three months
Description
fracture healing condition was checked by radiological examination.
Time Frame
three months postoperative
Title
rate of femoral medialization
Description
femoral medialization
Time Frame
one year postoperative
Title
collodiaphyseal angle
Description
collodiaphyseal angle
Time Frame
one year postoperative
Title
weight bearing
Description
time of weight bearing
Time Frame
perioperation
Title
rate of patient satisfaction with treatment
Description
1-year VAS satisfaction
Time Frame
one year postoperative
Title
Hip function score
Description
OHS
Time Frame
preoperative, six months and one year postoperative
Title
time of surgical during
Description
The time from the beginning to the end of the surgery
Time Frame
Perioperative
Title
fluoroscopy time
Description
Duration of fluoroscopy
Time Frame
intraoperative
Title
rate of complications related to implant
Description
cut out, nonunion, implant breakage/failure, infection
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tang Peifu, Dr.
Phone
861099638101
Email
pftang301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shen Jing, Dr.
Phone
8613718623511
Email
orthjing@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tang Peifu
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedics department; The General Hospital of the People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang Peifu, Dr.
Phone
861099638101
Email
pftang301@126.com
First Name & Middle Initial & Last Name & Degree
Zhang li Hai, Dr.
First Name & Middle Initial & Last Name & Degree
Shen Jing, Dr.

12. IPD Sharing Statement

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Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail

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