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Completed

NCT Number: NCT05053048

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

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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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SL-PLUS-Stem for total hip arthroplasty

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.

Primary outcomes

  1. Baseline Bone mineral density by DEXA

    Time frame: Measurements will be performed 7 days (baseline) after surgery

    Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).

  2. Change from baseline Bone mineral density by DEXA at 3 months

    Time frame: Measurements will be performed 3 months postoperatively

    Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).

  3. Change from baseline Bone mineral density by DEXA at 6 months

    Time frame: Measurements will be performed 6 months postoperatively

    Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).

  4. Change from baseline Bone mineral density by DEXA at 12 months

    Time frame: Measurements will be performed 12 months postoperatively

    Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).

  5. Change from baseline Bone mineral density by DEXA at 24 months

    Time frame: Measurements will be performed 24 months postoperatively

    Bone mineral density around the stem is measured as a surrogate for prosthesis in-growth by a dual-energy x-ray absorptiometry device (DEXA) (General Electric).

Secondary outcomes

  1. Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months

    Time frame: Measurements will be performed at 12 months postoperatively.

    Assessment of radiographs for radiolucent lines (RLs) around the stem.

  2. Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months

    Time frame: Measurements will be performed at 24 months postoperatively.

    Assessment of radiographs for radiolucent lines (RLs) around the stem.

  3. Rate of osteolysis on hip radiographs (AP and axial) at 12 months

    Time frame: Measurements will be performed at 12 months postoperatively.

    Assessment of radiographs for osteolysis around the stem.

  4. Rate of osteolysis on hip radiographs (AP and axial) at 24 months

    Time frame: Measurements will be performed at 24 months postoperatively.

    Assessment of radiographs for osteolysis around the stem.

  5. Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months

    Time frame: Measurements will be performed at 12 months postoperatively.

    Assessment of radiographs for hypertrophies and atrophies around the stem.

  6. Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.

    Time frame: Measurements will be performed at 24 months postoperatively.

    Assessment of radiographs for hypertrophies and atrophies around the stem.

  7. Baseline WOMAC

    Time frame: Measurements will be performed 1 month preoperatively.

    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.

  8. Change in WOMAC at 12 months

    Time frame: Measurements will be performed 12 months postoperatively

    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.

  9. Change in WOMAC at 24 months

    Time frame: Measurements will be performed 24 months postoperatively

    For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.

  10. Baseline HHS

    Time frame: Measurements will be performed 1 month preoperatively.

    For clinical scoring, the Harris Hip Score (HHS) will be assessed.

  11. Change in HHS at 12 months

    Time frame: Measurements will be performed 12 months postoperatively

    For clinical scoring, the Harris Hip Score (HHS) will be assessed.

  12. Change in HHS at 24 months

    Time frame: Measurements will be performed 24 months postoperatively

    For clinical scoring, the Harris Hip Score (HHS) will be assessed.

  13. Survival rates

    Time frame: Up to 24 months postoperatively.

    THA survival rates and adverse events will be documented up to 24 months postoperatively.

Sponsors and collaborators

Lead sponsor

Kantonsspital Baselland Bruderholz

Other

Collaborators

  • Smith & Nephew, Inc.

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2012
First posted
Sep 22, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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