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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
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.
Baseline Bone mineral density by DEXA
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).
Time frame: Measurements will be performed 7 days (baseline) after surgery
Change from baseline Bone mineral density by DEXA at 3 months
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).
Time frame: Measurements will be performed 3 months postoperatively
Change from baseline Bone mineral density by DEXA at 6 months
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).
Time frame: Measurements will be performed 6 months postoperatively
Change from baseline Bone mineral density by DEXA at 12 months
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).
Time frame: Measurements will be performed 12 months postoperatively
Change from baseline Bone mineral density by DEXA at 24 months
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).
Time frame: Measurements will be performed 24 months postoperatively
Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months
Assessment of radiographs for radiolucent lines (RLs) around the stem.
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Time frame: Measurements will be performed at 12 months postoperatively.
Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months
Assessment of radiographs for radiolucent lines (RLs) around the stem.
Time frame: Measurements will be performed at 24 months postoperatively.
Rate of osteolysis on hip radiographs (AP and axial) at 12 months
Assessment of radiographs for osteolysis around the stem.
Time frame: Measurements will be performed at 12 months postoperatively.
Rate of osteolysis on hip radiographs (AP and axial) at 24 months
Assessment of radiographs for osteolysis around the stem.
Time frame: Measurements will be performed at 24 months postoperatively.
Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months
Assessment of radiographs for hypertrophies and atrophies around the stem.
Time frame: Measurements will be performed at 12 months postoperatively.
Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months.
Assessment of radiographs for hypertrophies and atrophies around the stem.
Time frame: Measurements will be performed at 24 months postoperatively.
Baseline WOMAC
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Time frame: Measurements will be performed 1 month preoperatively.
Change in WOMAC at 12 months
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Time frame: Measurements will be performed 12 months postoperatively
Change in WOMAC at 24 months
For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed.
Time frame: Measurements will be performed 24 months postoperatively
Baseline HHS
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Time frame: Measurements will be performed 1 month preoperatively.
Change in HHS at 12 months
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Time frame: Measurements will be performed 12 months postoperatively
Change in HHS at 24 months
For clinical scoring, the Harris Hip Score (HHS) will be assessed.
Time frame: Measurements will be performed 24 months postoperatively
Survival rates
THA survival rates and adverse events will be documented up to 24 months postoperatively.
Time frame: Up to 24 months postoperatively.