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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Notify MeKey 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
Primary outcomes
-
short term bone remodeling
Time frame: 6 times within 2 years
Bone remodeling is determined by measuring the Bone mineral density during time
-
complications and reoperations
Time frame: during 5 years
Reporting all complications and reoperations of the two different hip prostheses
Secondary outcomes
-
clinical performance
Time frame: 9 times within 5 years
Comparison of the clinical performance of the two different hip prostheses
-
Radiological evaluation
Time frame: 9 times within 5 years
Evaluation of Xrays according to the engh classifications
Other outcomes
-
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.