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

Phase 4

Completed

• Conditions: Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis
• Interventions: Procedure: uncemented total hip arthroplasty

• Registration Number: NCT01695213
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Last Update Submitted: 2012-09-25
• Study First Posted: 2012-09-27
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA-Omnifit	uncemented total hip arthroplasty	Patients who receive a HA-Omnifit uncemented hip stem
Symax hip stem	uncemented total hip arthroplasty	Patients with the Symax uncemented hip stem

Primary Outcome Measures

Name	Time	Method
short term bone remodeling	6 times within 2 years	Bone remodeling is determined by measuring the Bone mineral density during time
complications and reoperations	during 5 years	Reporting all complications and reoperations of the two different hip prostheses

Secondary Outcome Measures

Name	Time	Method
clinical performance	9 times within 5 years	Comparison of the clinical performance of the two different hip prostheses
Radiological evaluation	9 times within 5 years	Evaluation of Xrays according to the engh classifications