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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-12-31

Study Completion Date

2014-07-31

Brief Summary

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

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Detailed Description

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This study protocol will provide guidance to investigators wanting to perform 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.

Conditions

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Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary cohort

Primary cohort of subjects who receive the HRA device.

HRA

Intervention Type DEVICE

Humeral head resurfacing with the HRA device

Interventions

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HRA

Humeral head resurfacing with the HRA device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No