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| Name | Class |
|---|---|
| Symbios Orthopedie SA | INDUSTRY |
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In this prospective randomized four-armed study the investigators aim to compare wheter 3-D planning, which necessitates preoperative CT acquisition and sophisticated planning together with engineers, results in measurable benefits in terms of objective and subjective outcome values in a collective of patients undergoing primary total hip replacement.
Hypothesis:
Patients sent to our outpatient clinic for eventual primary THR are informed about this study and written patient information given to them. When patients decide to undergo primary total hip replacement, patient's questions with respect to this study are discussed in the outpatient clinic and patients willing to participate included.
Block randomization using closed envelopes for age categories 40-50, 50-60, 60-70 years will be conducted to assign the participant to one of the four study arms.
Patients will be blinded for the type of stem and method of planning. Investigators are blined in terms of methods of planning. In terms of stem design, investigators can not be blinded since their visibility on x-ray does not allow it.
The preoperative investigation includes routine investigation and an additional CT scan plus evaluation of the "University of California at Los Angeles" (UCLA) activity level and "Short Form Health 36" (SF-36) score. The same applies for the postoperative investigation and 3 months. The follow-up visits at 1, 5 and 10 years are routine investigations with additional UCLA and SF-36 Scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D anatomical stem | Experimental | 3-D-Planing with anatomical stem (SPS monoblock stem, Symbios) |
|
| 3D non-anatomical stem | Experimental | 3-D-Planing with non anatomical stem (Quadra-H, Medacta) |
|
| 2D anatomical stem | Experimental | 2-D-Planing with anatomical stem (SPS monoblock stem, Symbios) |
|
| 2D non anatomical stem | Experimental | 2-D-Planning with non anatomical Stem (Quadra-H, Medacta) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPS monoblock stem, Symbios | Device | hip prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients, including pain, stiffness, and physical functioning of the hip. A difference in WOMAC of 2.5 points is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year WOMAC significantly differs by 2.5. | Change from basline to one year |
| Change in subjective hip value (SHV) | The subjective hip value (SHV) is as a patient-reported outcome measurement (PROM) which is reported by the patient. It is easily and quickly performed and interpreted. The SHV is defined as a patient's subjective hip satisfaction expressed as a percentage of 100%, which is the score that an entirely normal hip joint would reach. A difference in subj. hip value of 25% is considered relevant. 3-D-planing and/or anatomical stems will be considered superior to 2-D-planing and /or non-anatomical stems if the one year subjective hip value significantly differs by 25%. | Change from basline to one year |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Quadra-H, Medacta | Device | hip prosthesis |
|
| 3D planning of THR | Procedure | primary total-hip replacement (THR) planned on 3-dimensional images (computer tomography) |
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| 2D planning of THR | Procedure | primary total-hip replacement (THR) planned on 2-dimensional images (anteroposteiros pelciv x-ray) |
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