No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 55
- Primary Endpoint
- Early and intermediate periprosthetic bone remodeling
Study Overview
Brief Summary
The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.
Detailed Description
60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants
Exclusion Criteria
- •infection, revision surgery, severe morbidity and obvious bone loss
Arms & Interventions
Bonemaster
Cement-less femoral stems with electrochemical deposition of hydroxyapatite
Intervention: Taperloc (Device)
Hydroxyapatite
Cement-less femoral stems with plasmasprayed hydroxyapatite
Intervention: Taperloc (Device)
Outcomes
Primary Outcomes
Early and intermediate periprosthetic bone remodeling
Time Frame: 5 years
Bone densitometry measured by DXA
Early and intermediate femoral stem stability
Time Frame: 5 years
Radiostereometric analysis of femoral stem movements relative to bone
Secondary Outcomes
- Clinical function(5 years)
- Radiographic signs of loosening(5 years)
Investigators
Lars Nordsletten
Professor Lars Nordsletten
Oslo University Hospital