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A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

NCT01587560 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-08-30

No results posted yet for this study

Summary

The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.

Conditions

  • Osteoarthritis of the Shoulder

Interventions

DEVICE

PyroTITAN, Ascension Orthopedics, Inc.

All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design.

DEVICE

TITAN, Ascension Orthopedics, Inc.

Sponsors & Collaborators

  • Ascension Orthopedics, Inc.

    collaborator INDUSTRY

  • Swedish Shoulder and Elbow Arthroplasty Register

    collaborator UNKNOWN

  • Karolinska Institutet

    collaborator OTHER

  • Danderyd Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-01-31
Completion
2018-01-31

Countries

  • Sweden

Study Locations

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Entities

Companies

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 NCT01587560 on ClinicalTrials.gov