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

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.

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Key information

Conditions

Primary Total Hip Arthroplasty

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Survival, Kaplan Meier

Time frame: up to 10 years after implantation

Survival rate: Rate of hip implants in situ after 10 years of follow-up.
Intra- und perioperative implant-related "Adverse Events" (AE) and complications until discharge

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

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
Postoperative AE up to 10 years after the surgery

Time frame: up to 10 years after implantation

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

Secondary outcomes

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

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

Time frame: up to 10 years after implantation

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.

Sponsors and collaborators

Lead sponsor

Smith & Nephew Orthopaedics AG

Industry

Registry information

Acronym: SL-PLUS MIA

Important dates

Study start: 2007
Primary completion: 2019
Study completion: 2019
First posted: Oct 10, 2019
Registry last updated: Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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