Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position

Study Overview
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Brief Summary
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A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.

Detailed Description
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The study objective was to evaluate if there was a difference between the femoral position of the last trial rasp and the final implant position of the SL-PLUS™ MIA Ti/HA femoral hip stem. The femoral position of rasp or stem was considered as the height of the implant / rasp in cranio-caudal direction.

Official Title
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Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient: requires primary THA with the SL-PLUS™ MIA Ti/HA femoral hip stem is at least 21 years of age at the time of surgery is skeletally mature in the PI's judgment has consented to participate in the study by signing the EC approved ICF Exclusion Criteria: Patient: requires the use of a ceramic-on-ceramic bearing has infections, acute or chronic, local or systemic has severe muscle, nerve or vascular diseases that endanger the respective limb has lack of bone substance or defective bone quality that jeopardizes the stable seating of the prosthesis has any concomitant disease that may jeopardize implant function has a known allergy to study device or one or more of its components requires a revision surgery and has extensive bone defects has diagnosis of an immunosuppressive disorder is pregnant

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total Hip Arthroplasty|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement | Difference D was measured using standardized fluoroscopic images taken during surgery. Investigators also reported any stem position corrections made as well as type of rasping instrument used. The difference D is given in millimeters (mm) and is defined as D = x1 - x2 with x1 being the distance between the shoulder of the trial rasp and the tip of the greater trochanter and x2 being the distance between the shoulder of the implant and the tip of the greater trochanter. | Intraoperative examination only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hips With Leg Length Discrepancy | Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem. | Preoperative, directly postoperative (approximately 3 months) | 
| Number of Hips With Intraoperative Complications | Intraoperative complications were collected as a secondary outcome. | Intraoperative examination only |