Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study

Stopped early · Not applicable

Conditions studied: Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder, Acquired Deformity of Head, Post-traumatic Arthrosis of Other Joints, Shoulder Region

In brief

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.

Key facts

Study ID

NCT02029469

Run by

Ascension Orthopedics, Inc.

People needed

59

Starts

2007-10-01

Expected to finish

2014-07-01

Last updated by the study team

2014-08-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Bay Pines VA Healthcare System — Bay Pines, Florida, United States

Full record on ClinicalTrials.gov

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