osteoarthritis shoulderprosthesis
Conditions
Interventions
None listed
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: · Patient presents with shoulder osteoarthritis and requires a TSP. · Patient reports moderate to severe pain in affected shoulder. · Patient is 18 to 80 years of age. · Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
Exclusion criteria
Exclusion criteria: · Patient diagnosed with posttraumatic osteoarthritis of the shoulder. · Patient has an active, local infection or systemic infection. · Patient has a BMI >35. · Patient has physical, emotional or neurological conditions that would compromise the patient*s compliance with postoperative rehabilitation protocol follow-up (e.g.: drug or alcohol abuse, serious mental illness, or general neurological conditions such as Parkinson, Multiple sclerosis, etc.). · Patient is pregnant or plans to become pregnant during the course of the RSA study. · Patient suffering postoperative complications such as infections, recurrent luxations, non compliance with normal postoperative care / rehabilitation program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is stability as measured with Radio Stereometric Analysis (RSA) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are: radiographic evaluation radiolucency, scored through a modification for pegged components of the Franklin system, grading radiolucent lines bordering keeled components grade of glenoid component seating pain, scored through 10-cm Visual Analog Scale (VAS) functional outcome, scored through Constant-Murley Score, Nederlandse Schouder Test, DASHscore | — |
Countries
Netherlands
Outcome results
None listed