An interventional study of Ascension HRA device in Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder and Acquired Deformity of Head, sponsored by Ascension Orthopedics, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-18.
Sponsored by Ascension Orthopedics, Inc. · Not applicable, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 59 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →This is the only study on the registry with Ascension Orthopedics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The following patient will be included in the study - Patient who:
Exclusion Criteria:
The following patients will be excluded from the study - Patients who:
Patients who will be treated with Ascension HRA device.
Device: Ascension HRA device
Patients who are treated with the Ascension® HRA for resurfacing of humeral head.
Also known as: Ascension Metal HRA device
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
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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