Treatment of Sub-capital Fractures of Hip Joint by Using TriboFit™ Acetabular Buffer

February 11, 2020 updated by: Active Implants

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

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

11

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
A

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Active Implants

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 16, 2009

Study Completion (Actual)

September 16, 2009

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLV-0021-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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