Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-08 @ 2:50 AM
Study NCT ID:
NCT00477360
Status:
UNKNOWN
Last Update Posted:
2011-08-11
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Humeral Resurfacing Hemiarthroplasty
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Humeral Resurfacing Hemiarthroplasty. Phase 2: Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2011-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP
Brief Summary:
The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.
Detailed Description:
Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: