N/A
Completed N=40
Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position
Source: ClinicalTrials.gov NCT02664272 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: 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 — 7.78; 5.15; 2.63 mm
Summary
A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
7.78; 5.15; 2.63 | — |
| SECONDARY Number of Hips With Leg Length Discrepancy |
24; 1; 16; 36; 1; 4 | — |
| SECONDARY Number of Hips With Intraoperative Complications |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02664272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.