Hip Osteoarthritis
Conditions
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.
Interventions
DEVICESL-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.
Sponsors
Smith & Nephew, Inc.
Kantonsspital Baselland Bruderholz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomised controlles trial, double-blind. Block randomization with block size 10.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years and older undergoing primary THA for primary or secondary osteoarthritis will be enrolled.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Bone mineral density by DEXA | 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). |
| Change from baseline Bone mineral density by DEXA at 3 months | 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). |
| Change from baseline Bone mineral density by DEXA at 6 months | 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). |
| Change from baseline Bone mineral density by DEXA at 12 months | 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). |
| Change from baseline Bone mineral density by DEXA at 24 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 24 months. | Measurements will be performed at 24 months postoperatively. | Assessment of radiographs for hypertrophies and atrophies around the stem. |
| Baseline WOMAC | Measurements will be performed 1 month preoperatively. | For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed. |
| Change in WOMAC at 12 months | Measurements will be performed 12 months postoperatively | For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed. |
| Change in WOMAC at 24 months | Measurements will be performed 24 months postoperatively | For clinical scoring, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be assessed. |
| Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months | Measurements will be performed at 12 months postoperatively. | Assessment of radiographs for radiolucent lines (RLs) around the stem. |
| Change in HHS at 12 months | Measurements will be performed 12 months postoperatively | For clinical scoring, the Harris Hip Score (HHS) will be assessed. |
| Change in HHS at 24 months | Measurements will be performed 24 months postoperatively | For clinical scoring, the Harris Hip Score (HHS) will be assessed. |
| Survival rates | Up to 24 months postoperatively. | THA survival rates and adverse events will be documented up to 24 months postoperatively. |
| Baseline HHS | Measurements will be performed 1 month preoperatively. | For clinical scoring, the Harris Hip Score (HHS) will be assessed. |
| Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months | Measurements will be performed at 24 months postoperatively. | Assessment of radiographs for radiolucent lines (RLs) around the stem. |
| Rate of osteolysis on hip radiographs (AP and axial) at 12 months | Measurements will be performed at 12 months postoperatively. | Assessment of radiographs for osteolysis around the stem. |
| Rate of osteolysis on hip radiographs (AP and axial) at 24 months | Measurements will be performed at 24 months postoperatively. | Assessment of radiographs for osteolysis around the stem. |
| Rate of hypertrophies and atrophies on hip radiographs (AP and axial) at 12 months | Measurements will be performed at 12 months postoperatively. | Assessment of radiographs for hypertrophies and atrophies around the stem. |
Outcome results
None listed