NCT01797237

Brief Summary

The purpose of this study is to determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

2.9 years

First QC Date

February 20, 2013

Last Update Submit

February 4, 2015

Conditions

Intertrochanteric Fracture

Keywords

surgeryfixationintramedullary nail

Outcome Measures

Primary Outcomes (1)

  • 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).

    six months

Secondary Outcomes (1)

  • Bone healing condition

    Six months

Other Outcomes (1)

  • Complications

    Six months

Study Arms (2)

Stable intertrochanteric fracture

EXPERIMENTAL

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

Device: PFNADevice: InterTAN

Unstable intertrochanteric fracture

EXPERIMENTAL

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

Device: PFNADevice: InterTAN

Interventions

PFNADEVICE
Also known as: Proximal Femoral Nail Antirotation (Synthes)
Stable intertrochanteric fractureUnstable intertrochanteric fracture
InterTANDEVICE
Also known as: InterTAN Femoral Nail (Smith&Nephew)
Stable intertrochanteric fractureUnstable intertrochanteric fracture

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The General Hospital of the People's Liberation Army

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Peifu Tang, MD

    Chinese PLA General Hospital

    STUDY CHAIR

  • Lihai Zhang, MD

    Chinese PLA General Hospital

    STUDY DIRECTOR

  • Qi Yao, MD

    Beijing Shijitan Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

  • Wen Zhao, MD

    Beijing Aerospace General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peifu Tang, MD

CONTACT

861099638101pftang301@126.com

Lihai Zhang, MD

CONTACT

861068212342zhanglihai@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Professor

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 22, 2013

Study Start

October 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

CN(1)