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Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft

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

Summary

Summary from initial protocol

Goal: Validation of the HA (hydroxylapatite) coated SL-PLUS™ stem within an observation study

Study design: prospective, multicenter, observational, non-comparative study

Study population: 240 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, implant-related complications, revisions; patient questionnaires HOOS and EQ-5D

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

Intervention

Total Hip Arthroplasty

Location

Orthopädie LKH Steyr
Steyr
Austria
4400

Status

Active, not recruiting

Source

Smith & Nephew, Inc.

Results (where available)

View Results

Links

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

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