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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STD-SL-PLUS stem | Experimental | 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. |
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| NT-SL-PLUS Stem | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 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). | 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). | Measurements will be performed 24 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of radiolucent lines on hip radiographs (AP and axial) at 12 months | Assessment of radiographs for radiolucent lines (RLs) around the stem. | Measurements will be performed at 12 months postoperatively. |
| Rate of radiolucent lines on hip radiographs (AP and axial) at 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niklaus F. Friederich, MD, Prof. | Kantonsspital Baselland Bruderholz | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38430413 | Derived | Moret CS, Masri SE, Schelker BL, Friederich NF, Hirschmann MT. Unexpected early loosening of rectangular straight femoral Zweymuller stems with an alumina-reduced surface after total hip arthroplasty-a prospective, double-blind, randomized controlled trial. J Orthop Traumatol. 2024 Mar 2;25(1):12. doi: 10.1186/s10195-023-00743-1. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Randomised controlles trial, double-blind. Block randomization with block size 10.
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Assessment of radiographs for radiolucent lines (RLs) around the stem. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Measurements will be performed 24 months postoperatively |
| Baseline HHS | For clinical scoring, the Harris Hip Score (HHS) will be assessed. | Measurements will be performed 1 month preoperatively. |
| Change in HHS at 12 months | For clinical scoring, the Harris Hip Score (HHS) will be assessed. | Measurements will be performed 12 months postoperatively |
| Change in HHS at 24 months | For clinical scoring, the Harris Hip Score (HHS) will be assessed. | Measurements will be performed 24 months postoperatively |
| Survival rates | THA survival rates and adverse events will be documented up to 24 months postoperatively. | Up to 24 months postoperatively. |
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |