Patients With Osteoarthritis of the Hip Joint Elligable for a Uncemented Hipprosthesis
Conditions
Keywords
uncemented hip, bone remodeling, DEXA, clinical evaluation
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.
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.
Interventions
PROCEDUREuncemented total hip arthroplasty
Sponsors
Stryker Orthopaedics
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| short term bone remodeling | 6 times within 2 years | Bone remodeling is determined by measuring the Bone mineral density during time |
| complications and reoperations | during 5 years | Reporting all complications and reoperations of the two different hip prostheses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical performance | 9 times within 5 years | Comparison of the clinical performance of the two different hip prostheses |
| Radiological evaluation | 9 times within 5 years | Evaluation of Xrays according to the engh classifications |
Other
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction | 9 times within 5 years | comparison of patient satisfaction between the two different prostheses |
Outcome results
None listed