MedTrace Logo

RSA Study of Sirius Stem and Exceed Cup

NCT02307331 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-09-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of the Sirius Cemented Stem used in conjunction with the Exceed ABT Cemented Acetabular Cup, either with E1 or Arcom polyethylene, and OptiPac/OptiVac bone cement mixing systems.

Conditions

Interventions

DEVICE

Optivac

A vacuum mixing system for cement with mixing and collection under vacuum but open initial mixture of powder and monomer. Has been used since 1993 with excellent results

DEVICE

Optipac

A vacuum mixing system for cement with mixing and collection under vacuum but with a pre-packed mixing system allowing for an all closed system minimizing exposure for monomer fumes. This is a relatively new mixing system

DEVICE

Arcom (Exceed cup)

The Exceed cup is available in two type of advanced bearing polyethylene material: The first is the 'classic', long term proven ArCom, a conventional polyethylene

DEVICE

E1 (Exceed cup)

The Exceed cup is available in two type of advanced bearing polyethylene material: The new is a highly cross linked polyethylene with infusion of vitamin E1 to remove free radicals in order to reduce wear.

DEVICE

Sirius stem

A polished tapered stem

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Region Skane

    lead OTHER

Principal Investigators

  • Gunnar Flivik, Md PhD · Dept of Orthopedics, Skane University Hospital, Lund University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2020-08-31
Completion
2023-09-02

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT02307331 on ClinicalTrials.gov