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

This study has been completed.
Sponsor:
Collaborator:
Stryker EMEA
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01695213
First received: September 25, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • short term bone remodeling [ Time Frame: 6 times within 2 years ] [ Designated as safety issue: No ]
    Bone remodeling is determined by measuring the Bone mineral density during time

  • complications and reoperations [ Time Frame: during 5 years ] [ Designated as safety issue: Yes ]
    Reporting all complications and reoperations of the two different hip prostheses


Secondary Outcome Measures:
  • clinical performance [ Time Frame: 9 times within 5 years ] [ Designated as safety issue: No ]
    Comparison of the clinical performance of the two different hip prostheses

  • Radiological evaluation [ Time Frame: 9 times within 5 years ] [ Designated as safety issue: No ]
    Evaluation of Xrays according to the engh classifications


Other Outcome Measures:
  • patient satisfaction [ Time Frame: 9 times within 5 years ] [ Designated as safety issue: No ]
    comparison of patient satisfaction between the two different prostheses


Enrollment: 50
Study Start Date: April 2003
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695213

Sponsors and Collaborators
Maastricht University Medical Center
Stryker EMEA
Investigators
Study Director: Lodewijk van Rhijn azM
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01695213     History of Changes
Other Study ID Numbers: Symax DEXA study, MEC 02-072
Study First Received: September 25, 2012
Last Updated: September 25, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on May 19, 2013