Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-28 @ 7:14 AM
Study NCT ID:
NCT03189303
Status:
COMPLETED
Last Update Posted:
2022-02-15
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cup Position in THA With Standard Instruments
Sponsor:
DePuy Orthopaedics
Organization:
Study Overview
Official Title:
Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Standard Instrumentation and Technique
Status:
COMPLETED
Status Verified Date:
2022-02
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:
None
Brief Summary:
Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.
Detailed Description:
This is a global, prospective, multi-center study with a planned analysis of a minimum of 176 Subjects. Up to 15 study sites will participate in this study. The primary and secondary endpoints are as follows:
Primary endpoint:
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.
Secondary endpoints:
1. Inclination success (as defined for the primary endpoint)
2. Version success (as defined for the primary endpoint)
3. 90-day complication rates
4. Change from preoperative baseline for the Harris Hip Score
5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)
6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable)
7. Change from 6 week baseline for the Forgotten Joint Score
Primary endpoint:
The primary endpoint is acetabular cup position success at 6 weeks postoperatively. Success is defined as cup inclination and version within 10 degrees of the plan.
Secondary endpoints:
1. Inclination success (as defined for the primary endpoint)
2. Version success (as defined for the primary endpoint)
3. 90-day complication rates
4. Change from preoperative baseline for the Harris Hip Score
5. Radiographic Outcomes (based upon: AP Hip, AP Pelvis, and Modified Lauenstein Lateral)
6. Change from preoperative baseline for the EQ-5D-5L (health state, EQ-VAS, and index value, if applicable)
7. Change from 6 week baseline for the Forgotten Joint Score
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: