A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

August 29, 2016 updated by: Olof Skoldenberg, Danderyd Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18288
        • Orthopaedic department, Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary or secondary osteoarthritis of the shoulder
  • Age 40-75 years
  • Patient capable of giving informed consent
  • Patient agrees to comply with the study plan

Exclusion Criteria:

  • Destruction of the proximal humerus
  • Insufficient bone stock
  • Deficient rotator cuff or earlier failed surgery of the rotator cuff
  • Large muscle defects or insufficient blood supply in the affected arm
  • Neuromuscular disorders
  • Infection, untreated malignancy or transmittable disease preventing the patient from fulfilling the study
  • Patient unwilling to comply with study regulations
  • Patient with earlier allergic reaction to pyrocarbon
  • Patient with known metastatic disease
  • Patient who has been treated with more than 10 mg corticosteroids (e.g. Prednisone) daily within 3 months from surgery.
  • Patient participating in other clinical study
  • Patient in need of glenoid replacement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pyrocarbon
Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)
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.
Other Names:
  • TITAN, Ascension Orthopedics, Inc.
Device: TITAN, Ascension Orthopedics, Inc.
Active Comparator: CoCr
Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)
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.
Other Names:
  • TITAN, Ascension Orthopedics, Inc.
Device: TITAN, Ascension Orthopedics, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fixation to bone as measured with radiostereometric analysis (RSA)
Time Frame: 24 months
Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical results after surgery as measured with EuroQol-5D(EQ-5D), American Shoulder and Elbow Surgeons Score(ASES), Constant score, and Western Ontario Osteoarthritis of the Shoulder index(WOOS)
Time Frame: 24-48 months
Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator.
24-48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Collaborators

Karolinska Institutet
Ascension Orthopedics, Inc.
Swedish Shoulder and Elbow Arthroplasty Register

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PyroTITAN DS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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