Prospective Single-center Long-term Observation of the SL-PLUS® MIA Stem (SL-PLUS MIA)

Smith & Nephew

Status: Completed

Conditions: Primary Total Hip Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT04122157

D10055-2

Details and patient eligibility

About

Summary from initial protocol

Goal: Validation of the uncoated SL-PLUS® MIA stem within an observation study

Study design: prospective, single-center, observational, non-comparative study

Study population: 135 consecutive cases (uncoated SL-PLUS® MIA implants)

Intervention (if applicable): Implantation of a total hip endoprosthesis

Main goals/endpoints: Radiological: radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration; clinical: Harris Hip Score, implant-related complications, revisions; patient questionnaire (WOMAC)

Type and extent of the risks associated with the study participation as well as benefits for the patient: All patients will benefit from the hip prostheses without exception. There are no increased risks for the patients participating in the study compared to patients who do not participate. Normal, necessary follow-up exams will be performed over the course of 10 years. These follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the benefit for the patients from the participation in the study is currently not yet foreseeable.

Enrollment: 135 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with primary or secondary hip osteoarthritis
• Patients scheduled for a first implantation
• Age at the time of surgery 40-80 years

Exclusion criteria

• Destruction of the acetabulum
• Deformation of the hip joint
• Deformation of the proximal femur
• Revision of failed hip endoprostheses
• Acute or recent infection of the joint or its surrounding region
• Acute or chronic systemic infections
• Marked atrophy or deformation of the upper femur
• Muscle atrophy or a neuromuscular disease
• Pathological fractures
• Per- to subtrochanteric fractures
• Conditions that would prevent secure anchoring of the hip prosthesis
• Obese patients with a BMI >35
• Patients not expected to have a successful rehabilitation