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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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.
Orthopaedic department, Danderyd Hospital
Stockholm, Stockholm County, Sweden
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.
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)
Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator.
Time frame: 24-48 months
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