A Randomized Comparative Study to Evaluate the Performance and Confirm the Safety of the Diocom Hip Syhstem in Cementless Hip Arthroplasty
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 50
- Primary Endpoint
- short term bone remodeling
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
HA-Omnifit
Patients who receive a HA-Omnifit uncemented hip stem
Intervention: uncemented total hip arthroplasty (Procedure)
Symax hip stem
Patients with the Symax uncemented hip stem
Intervention: uncemented total hip arthroplasty (Procedure)
Outcomes
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(9 times within 5 years)
- Radiological evaluation(9 times within 5 years)