Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-28 @ 12:54 PM
Study NCT ID:
NCT01427361
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2010-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcome of Birmingham Hip Resurfacing (BHR) Using VISIONAIRE Femoral Alignment Guide
Sponsor:
Smith & Nephew, Inc.
Organization:
Study Overview
Official Title:
Prospective, Multi- Site, Clinical Study of Clinical Outcomes Following Hip Resurfacing Using VISIONAIRE Femoral Alignment Guide
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
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:
BHR
Brief Summary:
The primary objective of this study is to investigate the accuracy of the femoral implant placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing (BHR) surgery postoperatively after total hip resurfacing using the BHR System.
Detailed Description:
This is a prospective, multi- site, clinical study of clinical outcomes following hip resurfacing using VISIONAIRE Femoral Alignment Guide. The objective of this study is to evaluate the safety and efficacy of the blocks and to assess alignment of the BHR system when using VISIONAIRE Femoral Alignment Guide. This study will also document any device-related surgical complications or adverse radiographic observations.
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?: