RCT Comparing the DEXA Results of the HA-Omnifit Versus the Symax Uncemented Hip Stem

Study Overview
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Brief Summary
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Thr purpose of this study is to compare the clinical and radiological results, as well as the femur bone density measurements of two uncemented total hip prostheses during 5 years of follow up.

Detailed Description
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It is of great importance for the function of uncemented total hip arthroplasty that the anchorage of the prosthesis in the bone of the femur is sufficient. This is of great importance in the prevention of stress shielding of the bone and to insure tranfer of forces from the prosthesis to the femur. The symax hip stem is developed to optimize stress tranfer to bone and insure mechanical stability. In this study the symax hip stem is compared to the HA_Omnifit hip stem (a frequently used and long term evaluated uncemented hip prosthesis) During the fist two years of follow up DEXA mesurments of bone mineral density are performed. Also patient satisfaction, patient fuction score and radiological evaluation measurements are done during 5 years of follow up. Our primary objective is: comparison of the short term bone remodelling surrounding the Symax hip stem to the short term remodeling surrounding the Stryker Omnifit HA hip stem measured by bone densitometry, clinical and radiographic evaluation.

Official Title
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A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty

Conditions
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Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis

Intervention / Treatment
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* Procedure: uncemented total hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Male or non pregnant female patients >18 years Patient with degenerative or traumatic changes to hip requiring hip replacement Patient with BMI<35 Patient signed informed consent Exclusion Criteria: chronic anti-inflammatory medication use> 3 months revision surgery to the affected femur Cancer therapy including immunosuppression, chemotherapy and radiation Pathological fractures, delayed ossification or non-union is likely to occur

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HA-Omnifit<br>Patients who receive a HA-Omnifit uncemented hip stem | Procedure: uncemented total hip arthroplasty<br> <br> |
| Active Comparator: Symax hip stem<br>Patients with the Symax uncemented hip stem | Procedure: uncemented total hip arthroplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short term bone remodeling | Bone remodeling is determined by measuring the Bone mineral density during time | 6 times within 2 years | 
| complications and reoperations | Reporting all complications and reoperations of the two different hip prostheses | during 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical performance | Comparison of the clinical performance of the two different hip prostheses | 9 times within 5 years | 
| Radiological evaluation | Evaluation of Xrays according to the engh classifications | 9 times within 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uncemented hip, bone remodeling, DEXA, clinical evaluation