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

NCT04121585 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-06-01

No results posted yet for this study

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.

Conditions

  • Primary Total Hip Arthroplasty

Interventions

DEVICE

Total Hip Arthroplasty

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

Sponsors & Collaborators

  • Smith & Nephew Orthopaedics AG

    lead INDUSTRY

Principal Investigators

  • K Zweymüller, Univ. Prof. Dr · Orthopädisches Krankenhaus Gersthof

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

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-12
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 NCT04121585 on ClinicalTrials.gov