Effect of an Alumina Free Device Surface on BMD in Patients Implanted With an SL-PLUS™ Femoral Stem for THA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-01

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlles trial, double-blind. Block randomization with block size 10.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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STD-SL-PLUS stem

Rectangular SL straight stems made of titanium alloy (Ti-6Al-7Nb). The control stem (STD-SL-PLUS stem) underwent alumina grit blasting to reach the adequate roughness of 4-6 micron.

Group Type EXPERIMENTAL

SL-PLUS-Stem for total hip arthroplasty

Intervention Type DEVICE

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.

NT-SL-PLUS Stem

Rectangular SL straight stems made of titanium alloy (Ti-6Al-7Nb). The experimental stem (NT SL-PLUS) underwent alumina grit blasting to reach the adequate roughness of 4-6 micron. The surface of the NT SL-PLUS stem was thereafter additionally treated chemically by short-acid etching with HF and mechanically by dry ice blasting in order to loosen and remove the residual alumina particles up to 96% without changing the existing surface microtopography.

Group Type ACTIVE_COMPARATOR

SL-PLUS-Stem for total hip arthroplasty

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE