A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

Study Overview
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Brief Summary
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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
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Osteoarthritis of the Shoulder

Intervention / Treatment
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* Device: PyroTITAN, Ascension Orthopedics, Inc.
* Device: TITAN, Ascension Orthopedics, Inc.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator. | 24-48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder, Arthroplasty, Pyrocarbon, Randomized controlled trial, Shoulder resurfacing