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A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

Primary Purpose

Osteoarthritis of the Shoulder

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PyroTITAN, Ascension Orthopedics, Inc.
TITAN, Ascension Orthopedics, Inc.
Sponsored by
Danderyd Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Shoulder focused on measuring Shoulder, Arthroplasty, Pyrocarbon, Randomized controlled trial, Shoulder resurfacing

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopaedic department, Danderyd Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pyrocarbon

CoCr

Arm Description

Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)

Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator.

Full Information

First Posted
February 17, 2012
Last Updated
August 29, 2016
Sponsor
Danderyd Hospital
Collaborators
Ascension Orthopedics, Inc., Swedish Shoulder and Elbow Arthroplasty Register, Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01587560
Brief Title
A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
Ascension Orthopedics, Inc., Swedish Shoulder and Elbow Arthroplasty Register, Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Shoulder
Keywords
Shoulder, Arthroplasty, Pyrocarbon, Randomized controlled trial, Shoulder resurfacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pyrocarbon
Arm Type
Active Comparator
Arm Description
Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)
Arm Title
CoCr
Arm Type
Active Comparator
Arm Description
Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)
Intervention Type
Device
Intervention Name(s)
PyroTITAN, Ascension Orthopedics, Inc.
Other Intervention Name(s)
TITAN, Ascension Orthopedics, Inc.
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TITAN, Ascension Orthopedics, Inc.
Primary Outcome Measure Information:
Title
Fixation to bone as measured with radiostereometric analysis (RSA)
Description
Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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)
Description
Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator.
Time Frame
24-48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Orthopaedic department, Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden

12. IPD Sharing Statement

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A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

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