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

Kantonsspital Baselland Bruderholz

Status: Completed

Conditions: Hip Osteoarthritis

Treatments: Device: SL-PLUS-Stem for total hip arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05053048

20052021

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years and older undergoing primary THA for primary or secondary osteoarthritis will be enrolled.

Exclusion criteria

• Exclusion criteria were ongoing therapy with cortisone or medications influencing bone metabolism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

STD-SL-PLUS stem

Experimental group

Description:

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.

Treatment:

Device: SL-PLUS-Stem for total hip arthroplasty

NT-SL-PLUS Stem

Active Comparator group

Description:

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.

Treatment:

Device: SL-PLUS-Stem for total hip arthroplasty