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

2019-10-16 10:39:35 | BioPortfolio

Summary

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 Design

Conditions

Primary Total Hip Arthroplasty

Status

Active, not recruiting

Source

Smith & Nephew, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-16T10:39:35-0400

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Medical and Biotech [MESH] Definitions

Partial or total replacement of a joint.

Partial or total replacement of one or more FINGERS, or a FINGER JOINT.

Distention of KIDNEY with the presence of PUS and suppurative destruction of the renal parenchyma. It is often associated with renal obstruction and can lead to total or nearly total loss of renal function.

Surgical reconstruction of a joint to relieve pain or restore motion.

A subtype of von Willebrand disease that results from a total or near total deficiency of VON WILLEBRAND FACTOR.

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