Hip Fracture Clinical Trial
Official title:
A Single Arm, Uni-Center, Prospective Clinical Investigation to Evaluate Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation
Verified date | February 2008 |
Source | OrthoMediTec |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.
Status | Suspended |
Enrollment | 20 |
Est. completion date | December 2009 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Male/Female with Intracapsular femoral fracture type Garden I-II and several III. 2. Age 50 to 75. 3. Subject able to comprehend and give informed consent for participation in this study. Exclusion Criteria: 1. Known active infectious disease. 2. Terminal diseases 3. Patients in high risk and/or acute cardio-vascular disease. 4. Known cognitive disorder, psychiatric and/or neurological disease 5. Physician objection. 6. Age under 50 or above 75. 7. Concurrent participation in any other clinical study 8. Patients cannot understand or not willing to sign the informed consent. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
OrthoMediTec |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety endpoint is measure by paucity incidence of treatment related major complications. | Study duration | Yes | |
Secondary | Efficacy endpoint is measure by the following: 1. A subject is scored a success if he had no revision surgery, hemi- arthroplasty or total hip replacement surgery by 12 months; 2. Time to functional recovery | Study duration | Yes |
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