Total Hip Arthroplasty
Conditions
Keywords
Total hip arthroplasty, Cemented acetabular cup, Vitamin-E, Radiostereometry, Fixation of cemented acetabular component in total hip arthroplasty
Brief summary
In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have superior wear resistance and improved mechanical properties as compared to that of standard highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE although several trials are ongoing. All of these trials use uncemented acetabular cups intended for biological fixation. In many countries the standard fixation method for the acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation when used in acetabular components. The aim of the study is to compare migration, linear wear and clinical results between two types of cemented acetabular cups.
Interventions
DEVICEVitamin-E diffused polyethylene acetabular component
Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
DEVICEStandard polyethylene acetabular component
Patients will undergo total hip arthroplasty using a standard cemented acetabular component
Sponsors
Zimmer Biomet
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Primary osteoarthritis of the hip * Willingness and ability to follow study-protocol
Exclusion criteria
* Inflammatory arthritis or secondary osteoarthritis. * Type C (stove pipe) femur * Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation of components * Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery * Ongoing oestrogen treatment * Not suited for the study for other reason (surgeons preference)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cup migration | 2 years | The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linear wear | 2 years | Linear head penetration measured with RSA at 2 years |
| Osteolysis | 10 years | Development of radiolucent lines between bone and cement around the cup. |
| Functional outcome | 2 years | Hip function measured with Harris hip score |
| Complication rate | 10 years | All hip-related complications and revision of implants |
| Cup migration total | 2 years | Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM). |
Countries
Sweden
Outcome results
None listed