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

NCT02664272 | Completed Results

• 1 other identifier: SL MIA rasp 15-4567-03
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Hips With Leg Length Discrepancy

  Preoperative, directly postoperative (approximately 3 months)

• Number of Hips With Intraoperative Complications

  Intraoperative examination only

Interventions

Total Hip Arthroplasty PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Smith & Nephew Orthopaedics AG: lead

Study Sites (3)

Universitätsklinik für Orthopädie, PMU Salzburg

Salzburg, Austria

Location

Charité Universitätsmedizin Berlin Centrum für Muskuloskeletale Chirurgie Klinik für Orthopädie

Berlin, Germany

Location

Orthopädische Chirurgie München

Munich, Germany

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

Basic fluoroscopic image analysis (intrinsic: resolution/technique and extrinsic: alignment/orientation to landmarks). The Guide to the Expression of Uncertainty in Measurement (GUM) was followed to estimate the combined uncertainty of the method.

Results Point of Contact

• Title: Vice President of Medical Affairs
• Organization: Smith & Nephew, Inc.

luca.orlandini@smith-nephew.com

+41 41 7662222

Study Officials

• Andy Weymann, MD, MBA

  Smith & Nephew Orthopaedics AG

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: April 6, 2016
• Primary Completion: June 7, 2017
• Study Completion: June 7, 2017
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); AU (1)