A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant
This trial is active, not recruiting.
|Condition||osteoarthritis of the shoulder|
|Treatments||pyrotitan, ascension orthopedics, inc., titan, ascension orthopedics, inc.|
|Collaborator||Ascension Orthopedics, Inc.|
|Start date||January 2012|
|End date||January 2017|
|Trial size||80 participants|
|Trial identifier||NCT01587560, PyroTITAN DS|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Fixation to bone as measured with radiostereometric analysis (RSA)
time frame: 24 months
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
Male or female participants from 40 years up to 75 years old.
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
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