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

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 Overview

• Status: Completed
• Conditions: Primary Total Hip Arthroplasty

• Study Type: Observational
• Enrollment (Actual): 135

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival, Kaplan Meier	Survival rate: Rate of hip implants in situ after 10 years of follow-up.	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	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	up to 10 years after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to 10 years after implantation
WOMAC Osteoarthritis Index	The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on I off toilet, heavy domestic duties, light domestic duties. The scale ranges from 0 - 100 whereas, a higher score indicates a favorable outcome.	up to 10 years after implantation

Collaborators and Investigators

• Sponsor: Smith & Nephew Orthopaedics AG
• Investigators: Principal Investigator: Vinzenz v. Auersperg, Prim. Dr., Orthopädie LKH Steyr

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2007
• Primary Completion (ACTUAL): November 11, 2019
• Study Completion (ACTUAL): November 11, 2019

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (ACTUAL): October 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Uncoated SL PLUS® MIA stem
• Other Study ID Numbers: D10055-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No