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Clinical Observation Study of the Hydroxylapatite-coated SLPLUS™MIA Hip Shaft

NCT04036071 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 165

Last updated 2023-06-01

No results posted yet for this study

Summary

Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SLPLUS

™ MIA stem within an observation study Study design: prospective, multicenter, observational, noncomparative study Study population: 300 consecutive cases (HA-coated implants), 60 cases per study site. 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, HOOS Score, EQ-5D, implant-related complications, revisions 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. In addition, study patients are asked to provide information on their general state of health and the condition of their hip in two questionnaires. These clinical and radiological follow-up exams will then be quantitatively evaluated within the scope of the study in accordance with a standardized protocol. Accordingly, the direct benefit for the patients from the participation in the study is currently not yet foreseeable.

Conditions

  • Primary Total Hip Arthroplasty

Interventions

DEVICE

Total Hip Arthroplasty

Total Hip Arthroplasty using the SL-PLUS™ MIA cement free hip stem

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Principal Investigators

  • K Zweymuller · Orthopädisches Krankenhaus Gersthof

  • Vinzenz v. Auersperg · Orthopädie LKH Steyr

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-05-15
Primary Completion
2020-10-27
Completion
2020-10-27

Countries

  • Austria

Study Locations

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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 NCT04036071 on ClinicalTrials.gov