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

NCT04122157 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2026-01-06

No results posted yet for this study

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.

Conditions

  • Primary Total Hip Arthroplasty

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Principal Investigators

  • Vinzenz v. Auersperg, Prim. Dr. · Orthopädie LKH Steyr

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-22
Primary Completion
2019-11-11
Completion
2019-11-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04122157 on ClinicalTrials.gov