It is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA prosthesis. Patients will be periodically assessed to collect data related to safety and effectiveness endpoints at the following intervals: preoperative, surgery/immediate post-op, 3 months, 6 months, 1 year, 2 year, 5 year, and 10 years.
At each assessment interval, information on complications and adverse events will be collected. In addition, shoulder joint range of motion will be collected, and implants will be evaluated radiographically to determine joint position and assess implant with regards to radiolucencies, subsidence and subluxation (migration). Patient satisfaction with regard to the effect of the implant on shoulder function, joint pain, and overall satisfaction will be assessed using a visual analog scale (VAS). Furthermore, if there are any implant revisions during the 10-year follow-up for any of the patients enrolled in the study, the implant and/or surrounding tissue will be harvested if possible and submitted for histopathological examination.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Patients who are treated with the Ascension® HRA for resurfacing of humeral head.
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
American Shoulder and Elbow Surgeon Score
The ASES score will be evaluated at 2 years and compared to baseline.
Time frame: Outcome data will be evaluated at 2 years
Range of Motion
Shoulder range of motion will be measured compared to baseline.
Time frame: 2 years
VAS scale for pain
VAS score for pain will be evaluated at 2 years and compared to baseline.
Time frame: 2 years
AP and axillary radiographs
Radiographs will be evaluated at 2 years for subsidence, lucent lines and evidence of movement or pending failure.
Time frame: 2 years
Adverse events
AEs will be assessed at each study timepoint
Time frame: 2 years and during entire trial
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