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Symax International Study

NCT03469687 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-03-19

No results posted yet for this study

Summary

The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.

Conditions

  • Hip Osteoarthritis
  • Prosthesis Durability

Interventions

DEVICE

Symax uncemented hip stem

Sponsors & Collaborators

  • Vejle Hospital

    collaborator OTHER

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2004-11-02
Primary Completion
2010-10-11
Completion
2010-10-11

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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 NCT03469687 on ClinicalTrials.gov