Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up Study

Stopped early

Conditions studied: Arthritis

In brief

This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.

Key facts

Study ID

NCT02369497

Run by

Integra LifeSciences Corporation

People needed

59

Starts

2007-12-01

Expected to finish

2014-07-01

Last updated by the study team

2015-02-24

Who can join

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

You may qualify if…

• Any patient who is to be treated with the Ascension HRA is eligible for inclusion in this study. Therefore, Principal Investigators should attempt to recruit all patients at the study site who are treated with the Ascension HRA
• 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…

• 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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