Clinical trial NCT05053048: Effect of an Alumina Free Device Surface on BMD in Patients Implanted With an SL-PLUS™ Femoral Stem for THA
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2021-09-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlles trial, double-blind. Block randomization with block size 10.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Baseline Bone mineral density by DEXA
timeFrame: Measurements will be performed 7 days (baseline) after surgery
measure: Change from baseline Bone mineral density by DEXA at 3 months
timeFrame: Measurements will be performed 3 months postoperatively
measure: Change from baseline Bone mineral density by DEXA at 6 months
timeFrame: Measurements will be performed 6 months postoperatively
measure: Change from baseline Bone mineral density by DEXA at 12 months
timeFrame: Measurements will be performed 12 months postoperatively
measure: Change from baseline Bone mineral density by DEXA at 24 months
timeFrame: Measurements will be performed 24 months postoperatively
Secondary outcomes:
measure: Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months
timeFrame: Measurements will be performed at 12 months postoperatively.
measure: Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months
timeFrame: Measurements will be performed at 24 months postoperatively.
measure: Rate of osteolysis on hip radiographs (AP and axial) at 12 months
timeFrame: Measurements will be performed at 12 months postoperatively.
measure: Rate of osteolysis on hip radiographs (AP and axial) at 24 months
timeFrame: Measurements will be performed at 24 months postoperatively.
measure: Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months
timeFrame: Measurements will be performed at 12 months postoperatively.
measure: Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.
timeFrame: Measurements will be performed at 24 months postoperatively.
measure: Baseline WOMAC
timeFrame: Measurements will be performed 1 month preoperatively.
measure: Change in WOMAC at 12 months
timeFrame: Measurements will be performed 12 months postoperatively
measure: Change in WOMAC at 24 months
timeFrame: Measurements will be performed 24 months postoperatively
measure: Baseline HHS
timeFrame: Measurements will be performed 1 month preoperatively.
measure: Change in HHS at 12 months
timeFrame: Measurements will be performed 12 months postoperatively
measure: Change in HHS at 24 months
timeFrame: Measurements will be performed 24 months postoperatively
measure: Survival rates
timeFrame: Up to 24 months postoperatively.
Other outcomes:
Locations:
Study officials:
affiliation: Kantonsspital Baselland Bruderholz
name: Niklaus F. Friederich, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: