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

NCT ID: NCT00663468

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-09-16

Brief Summary

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

Conditions

Hip Fractures

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

A

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Active Implants

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TLV-0021-08

Identifier Type: -

Identifier Source: org_study_id