NCT00521716

Brief Summary

The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

August 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 12, 2009

Status Verified

February 1, 2008

Enrollment Period

6 months

First QC Date

August 26, 2007

Last Update Submit

January 9, 2009

Conditions

Hip Fracture

Keywords

Hip Prosthesis Implantation

Outcome Measures

Primary Outcomes (1)

  • The safety endpoint is measure by paucity incidence of treatment related major complications.

    Study duration

Secondary Outcomes (1)

  • Efficacy endpoint is measure by the following: 1. A subject is scored a success if he had no revision surgery, hemi- arthroplasty or total hip replacement surgery by 12 months; 2. Time to functional recovery

    Study duration

Study Arms (1)

A

EXPERIMENTAL
Device: Intracapsular Femoral Fracture FixationDevice: WaisFix100i for Intracapsular Femoral Fracture Fixation

Interventions

Intracapsular Femoral Fracture FixationDEVICE

The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.

Also known as: WaisFix100i
A
WaisFix100i for Intracapsular Femoral Fracture FixationDEVICE

The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.

A

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/Female with Intracapsular femoral fracture type Garden I-II and several III.
  • Age 50 to 75.
  • Subject able to comprehend and give informed consent for participation in this study.

You may not qualify if:

  • Known active infectious disease.
  • Terminal diseases
  • Patients in high risk and/or acute cardio-vascular disease.
  • Known cognitive disorder, psychiatric and/or neurological disease
  • Physician objection.
  • Age under 50 or above 75.
  • Concurrent participation in any other clinical study
  • Patients cannot understand or not willing to sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

carmel Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Marc Waisman, Dr.

    Carmel medical Center, Haifa Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 26, 2007

First Posted

August 28, 2007

Study Start

September 1, 2007

Primary Completion

March 1, 2008

Study Completion

December 1, 2009

Last Updated

January 12, 2009

Record last verified: 2008-02

Locations

IL(1)