Trials / Completed
CompletedNCT05053048
Effect of an Alumina Free Device Surface on BMD in Patients Implanted With an SL-PLUS™ Femoral Stem for THA
A Market Surveillance Study Assessing the Effect of an Alumina Free Device Surface on Bone Mineral Density in Patients Implanted With an SL-PLUS™ Femoral Stem for Total Hip Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Kantonsspital Baselland Bruderholz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Alumina particles from the grit blasting of Ti-alloy stems for hip arthroplasty are suspected to contribute to aseptic loosening. An alumina-reduced stem surface was hypothesized to improve osseointegration and show comparable short-term outcomes to those of a standard stem.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SL-PLUS-Stem for total hip arthroplasty | Patients undergoing primary total hip arthroplasty are randomly assigned (1:1) to receive either an uncemented NT-SL-PLUS Stem (Smith\&Nephew Orthopaedics AG, Aarau, Switzerland) or a matching uncemented STD-SL-PLUS stem (Smith\&Nephew Orthopaedics AG, Aarau, Switzerland) in a blinded fashion. |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2008-09-30
- Completion
- 2012-05-31
- First posted
- 2021-09-22
- Last updated
- 2021-09-22
Source: ClinicalTrials.gov record NCT05053048. Inclusion in this directory is not an endorsement.