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

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Total Hip Arthroplasty

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria
    • Universitätsklinik für Orthopädie, PMU Salzburg
• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin Centrum für Muskuloskeletale Chirurgie Klinik für Orthopädie
  • Munich, Germany
    • Orthopädische Chirurgie München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in this multicenter clinical observation had at least one of the indications listed below and met all of the inclusion criteria. Patients who met any of the exclusion criteria were not eligible for this study.

Indications:

• Advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis
• Fracture or avascular necrosis of the femoral head
• Follow-on conditions after previous surgery such as osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Study Director: Andy Weymann, MD, MBA, Smith & Nephew Orthopaedics AG

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2016
• Primary Completion (Actual): June 7, 2017
• Study Completion (Actual): June 7, 2017

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SL MIA rasp 15-4567-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO