Study Stopped
PI left institution and site did not have resources to continue study
Ascension® Humeral Resurfacing Arthroplasty (HRA) Follow-Up Study
HRA
1 other identifier
observational
59
1 country
1
Brief Summary
This is a prospective study on the Ascension HRA device to collect data to assess the safety and effectiveness of the HRA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 4, 2014
CompletedFirst Posted
Study publicly available on registry
February 24, 2015
CompletedFebruary 24, 2015
February 1, 2015
6.6 years
November 4, 2014
February 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
American Shoulder and Elbow Surgeons (ASES) Score
The American Shoulder and Elbow Score is a functional outcome tool that has been validated for various shoulder conditions
2 years
Secondary Outcomes (4)
Range of Motion
2 years
Visual Analog Scale for pain
2 years
X-rays
2 years
Adverse events
Surgery; 3 month, 6 month, 1 year and 2 years post-op
Study Arms (1)
Primary cohort
Primary cohort of subjects who receive the HRA device.
Interventions
Eligibility Criteria
Patients with arthritis requiring humeral resurfacing arthroplasty
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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Candi Langmaid, MPH, CCRP
Integra LifeSciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2014
First Posted
February 24, 2015
Study Start
December 1, 2007
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
February 24, 2015
Record last verified: 2015-02