Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

Conditions:Arthritis, Osteoarthritis (OA), Orthopedic, Women's Studies
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry, Reproductive
Age Range:18 - 75
Start Date:October 2007
End Date:December 2022

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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

Inclusion Criteria:

- The following patient will be included in the study - Patient who:

- Is treated with the Ascension HRA;

- Is disabled by either non-inflammatory or inflammatory arthritis (i.e.
rheumatoid arthritis, osteoarthritis and avascular necrosis;

- Has mild or moderate humeral head deformity and /or limited motion;

- Has post-traumatic arthritis;

- Has an intact or reparable rotator cuff;

- Has the means and ability to return for all required study visits

- Is willing to participate in the study;

- Has signed an Informed Consent Form;

- Is at least 18 years of age and skeletally mature at the time of surgery;

- Is less than 75 years of age at the time of surgery

Exclusion Criteria:

The following patients will be excluded from the study - Patients who:

- Infection, sepsis, and osteomyelitis;

- Osteoporosis;

- Metabolic disorders which may impair bone formation;

- Osteomalacia;

- Rapid joint destruction, marked bone loss or bone resorption apparent on X-ray;

- Revision procedures where other devices or treatments have failed

- Refuses to be in the study; or does not have the means and ability to return for all
required study visits;

- Currently participating in another clinical study.
We found this trial at
Bay Pines, Florida 33744
Bay Pines, FL
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