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Outcome Comparison Between PFNA and InterTAN

Primary Purpose

Intertrochanteric Fracture

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
PFNA
InterTAN
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

60 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

  • The General Hospital of the People's Liberation ArmyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stable intertrochanteric fracture

Unstable intertrochanteric fracture

Arm Description

The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.

The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.

Outcomes

Primary Outcome Measures

Quality of life
Assessment the quality of life by SF-36 (The Short Form Health Survey), ADL (Activities of Daily Living), FIM (Functional Independence Measure).

Secondary Outcome Measures

Bone healing condition
Bone healing condition was checked by radiological examination.

Full Information

First Posted
February 20, 2013
Last Updated
February 4, 2015
Sponsor
Peifu Tang
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1. Study Identification

Unique Protocol Identification Number
NCT01797237
Brief Title
Outcome Comparison Between PFNA and InterTAN
Official Title
Outcome Comparison Between PFNA and InterTAN in Intertrochanteric Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (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 two intramedullary fixations are effectively 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.

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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stable intertrochanteric fracture
Arm Type
Experimental
Arm Description
The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification.
Arm Title
Unstable intertrochanteric fracture
Arm Type
Experimental
Arm Description
The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification.
Intervention Type
Device
Intervention Name(s)
PFNA
Other Intervention Name(s)
Proximal Femoral Nail Antirotation (Synthes)
Intervention Type
Device
Intervention Name(s)
InterTAN
Other Intervention Name(s)
InterTAN Femoral Nail (Smith&Nephew)
Primary Outcome Measure Information:
Title
Quality of life
Description
Assessment the quality of life by SF-36 (The Short Form Health Survey), ADL (Activities of Daily Living), FIM (Functional Independence Measure).
Time Frame
six months
Secondary Outcome Measure Information:
Title
Bone healing condition
Description
Bone healing condition was checked by radiological examination.
Time Frame
Six months
Other Pre-specified Outcome Measures:
Title
Complications
Description
Death, implant breakage/failure, secondary fracture, infection and VTE (Venous Thromboembolism).
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 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
Peifu Tang, MD
Phone
861099638101
Email
pftang301@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lihai Zhang, MD
Phone
861068212342
Email
zhanglihai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peifu Tang, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lihai Zhang, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qi Yao, MD
Organizational Affiliation
Beijing Shijitan Hospital, Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wen Zhao, MD
Organizational Affiliation
Beijing Aerospace General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
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
Peifu Tang, MD
Phone
861099638101
Email
pftang301@126.com
First Name & Middle Initial & Last Name & Degree
Lihai Zhang, MD

12. IPD Sharing Statement

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Outcome Comparison Between PFNA and InterTAN

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