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Completed

NCT Number: NCT01695213

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

uncemented total hip arthroplasty

Procedure

Primary outcomes

  1. short term bone remodeling

    Time frame: 6 times within 2 years

    Bone remodeling is determined by measuring the Bone mineral density during time

  2. complications and reoperations

    Time frame: during 5 years

    Reporting all complications and reoperations of the two different hip prostheses

Secondary outcomes

  1. clinical performance

    Time frame: 9 times within 5 years

    Comparison of the clinical performance of the two different hip prostheses

  2. Radiological evaluation

    Time frame: 9 times within 5 years

    Evaluation of Xrays according to the engh classifications

Other outcomes

  1. patient satisfaction

    Time frame: 9 times within 5 years

    comparison of patient satisfaction between the two different prostheses

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Stryker Orthopaedics

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 27, 2012
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.