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

Smith & Nephew Orthopaedics AG135 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Primary Total Hip Arthroplasty

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Survival, Kaplan Meier

Survival rate: Rate of hip implants in situ after 10 years of follow-up.

Time frame: up to 10 years after implantation

Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge

Rate of hip implant experiencing intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge. Rate of hip implants with Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects

Time frame: up to patient's discharge from the hospital/clinic (from surgery up to 7 days after surgery)

Postoperative AE up to 10 years after the surgery

Rate of hip implants experiencing Postoperative AE up to 10 years after the surgery Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects

Time frame: up to 10 years after implantation

Secondary Outcomes

Radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.

Rate of hip implants with radiographic changes defined as radiolucent lines, osteolysis, hypo- and hypertrophy of the cortex, loosening of the implant or migration.

Time frame: up to 10 years after implantation

Harris Hip Score

The Harris Hip Score (HHS) is a clinician-based outcome measure frequently used for the evaluation of patients following a total hip arthroplasty.The score considers information on pain, function and range of motion. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.

Time frame: up to 10 years after implantation