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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Active Implants.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663468
First Posted: April 22, 2008
Last Update Posted: September 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Active Implants
  Purpose

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

Condition
Hip Fractures

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Active Implants:

Enrollment: 11
Study Start Date: April 2008

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Active Implants
ClinicalTrials.gov Identifier: NCT00663468     History of Changes
Other Study ID Numbers: TLV-0021-08
First Submitted: April 17, 2008
First Posted: April 22, 2008
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by Active Implants:
determine changes in patient pain level
determine changes in patient functionality
determine changes in patient life quality

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries