Osteoarthritis of the Shoulder
Conditions
Keywords
Shoulder, Arthroplasty, Pyrocarbon, Randomized controlled trial, Shoulder resurfacing
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.
Interventions
DEVICEPyroTITAN, 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.
DEVICETITAN, Ascension Orthopedics, Inc.
Sponsors
Ascension Orthopedics, Inc.
Swedish Shoulder and Elbow Arthroplasty Register
Karolinska Institutet
Danderyd Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fixation to bone as measured with radiostereometric analysis (RSA) | 24 months | Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 24-48 months | Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator. |
Countries
Sweden
Outcome results
None listed