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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695213
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : September 27, 2012
Stryker European Operations BV
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis Procedure: uncemented total hip arthroplasty Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty
Study Start Date : April 2003
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: HA-Omnifit
Patients who receive a HA-Omnifit uncemented hip stem
Procedure: uncemented total hip arthroplasty
Active Comparator: Symax hip stem
Patients with the Symax uncemented hip stem
Procedure: uncemented total hip arthroplasty

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. patient satisfaction [ Time Frame: 9 times within 5 years ]
    comparison of patient satisfaction between the two different prostheses

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695213

Sponsors and Collaborators
Maastricht University Medical Center
Stryker European Operations BV
Study Director: Lodewijk van Rhijn azM

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center Identifier: NCT01695213     History of Changes
Other Study ID Numbers: Symax DEXA study
MEC 02-072 ( Other Identifier: METC MUMC Maastricht )
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012

Keywords provided by Maastricht University Medical Center:
uncemented hip
bone remodeling
clinical evaluation

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases