NCT00663468

Brief Summary

The purpose of this study is to determine the performance and efficacy during 6 and 12 month post operation.

  1. 1.determine changes in patient pain level
  2. 2.determine changes in patient functionality
  3. 3.determine changes in patient life quality

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Status
terminated

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

April 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2009

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

April 17, 2008

Last Update Submit

February 11, 2020

Conditions

Keywords

determine changes in patient pain leveldetermine changes in patient functionalitydetermine changes in patient life quality

Study Arms (1)

A

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • Female or male that is not younger than 60 years old.
  • Patient suffers from hip fracture that will need hip arthroplasty.
  • Patient that weight less than 150Kg
  • Patient femur head diameter between 40mm - 50mm
  • Mentally normal
  • Patient that could walk before suffering from hip fracture
  • Patient that willing to cooperate with the doctor
  • Patient that signed on the acceptance form

You may not qualify if:

  • Patient that does not willing to cooperate with the doctor
  • Patient that is legally rejected
  • Patient that suffer from cancer
  • Patient that had passed amputation in is limbs
  • Patient that is paralysis
  • Patient that passed CVA or TIA
  • Patient that still recovering from hard wounds or surgery
  • Patient that suffer from infection in the hip joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 22, 2008

Study Start

April 1, 2008

Primary Completion

September 16, 2009

Study Completion

September 16, 2009

Last Updated

February 12, 2020

Record last verified: 2020-02