NCT01437176

Brief Summary

The purpose of this study is to determine whether this new intramedullary fixation is effective 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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

September 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

11 years

First QC Date

September 1, 2011

Last Update Submit

September 17, 2022

Conditions

Intertrochanteric Fracture

Keywords

surgeryfixationintramedullary nail

Outcome Measures

Primary Outcomes (1)

  • Postoperative quality of life score

    SF-36 PCS

    preoperative, six months and one year postoperative

Secondary Outcomes (9)

  • rate of fracture healing at three months

    three months postoperative

  • rate of femoral medialization

    one year postoperative

  • collodiaphyseal angle

    one year postoperative

  • weight bearing

    perioperation

  • rate of patient satisfaction with treatment

    one year postoperative

  • +4 more secondary outcomes

Study Arms (2)

Unstable intertrochanteric fracture fixed with novel nail

EXPERIMENTAL

AO/OTA A2 fracture fixed with novel nail

Device: new type of intramedullary nail

unstable intertrochanteric fracture fixed with PFNA

EXPERIMENTAL

AO/OTA A2 fracture fixed with PFNA

Device: The intramedullary nail of PFNA

Interventions

new type of intramedullary nailDEVICE

This is a new fixation treat for intertrochanteric fracture.

Also known as: WEIGAO ORTHOPAEDIC DEVICE CO.LTD., ZL201020121021.6
Unstable intertrochanteric fracture fixed with novel nail
The intramedullary nail of PFNADEVICE

It was used very common in treat with intertrochanteric fracture.

Also known as: AO Foundation, PFNA(proximal femoral nail antirotation)
unstable intertrochanteric fracture fixed with PFNA

Eligibility Criteria

Age18 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)

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

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38772935DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Tang Peifu

    Chinese PLA General Hospital

    STUDY CHAIR

Central Study Contacts

Tang Peifu, Dr.

CONTACT

861099638101pftang301@126.com

Shen Jing, Dr.

CONTACT

8613718623511orthjing@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Professor

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 20, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2022

Study Completion

August 1, 2024

Last Updated

September 21, 2022

Record last verified: 2022-09

Locations

CN(1)