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

Smith & Nephew

Status: Completed

Conditions: Osteoarthritis

Treatments: Procedure: Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT02664272

SL MIA rasp 15-4567-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design