Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Active Implants
ClinicalTrials.gov Identifier:
NCT00663468
First received: April 17, 2008
Last updated: September 21, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Active Implants:

Enrollment: 11
Study Start Date: April 2008

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Active Implants
ClinicalTrials.gov Identifier: NCT00663468     History of Changes
Other Study ID Numbers: TLV-0021-08
Study First Received: April 17, 2008
Last Updated: September 21, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 23, 2013