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

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 4

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

Treatments: Procedure: uncemented total hip arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01695213

Symax DEXA study

MEC 02-072 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

HA-Omnifit

Active Comparator group

Description:

Patients who receive a HA-Omnifit uncemented hip stem

Treatment:

Procedure: uncemented total hip arthroplasty

Symax hip stem

Active Comparator group

Description:

Patients with the Symax uncemented hip stem

Treatment:

Procedure: uncemented total hip arthroplasty