Intraoperative Case Series Study: Trial Rasp Position Versus SL-PLUS™ MIA Ti/HA Femoral Hip Stem Position
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
Brief Summary
A prospective, multicenter, observational study using the SL-PLUS™ MIA Ti/HA femoral hip stem with the appropriate set of instruments.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
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
Time Frame: Intraoperative examination only
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.
Secondary Outcomes
- Number of Hips With Intraoperative Complications(Intraoperative examination only)
- Number of Hips With Leg Length Discrepancy(Preoperative, directly postoperative (approximately 3 months))