Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-31 @ 1:23 PM
Study NCT ID:
NCT04191733
Status:
TERMINATED
Last Update Posted:
2023-09-15
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anterior Advantage With KINCISE
Sponsor:
DePuy Orthopaedics
Organization:
Study Overview
Official Title:
Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor terminated study early. Data collection was sufficient to adequately assess primary endpoint.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a post-market prospective, 1:1 randomized, multicenter non-inferiority study to compare the femoral broaching time for THA with the Anterior Advantage approach with KINCISE vs. without KINCISE. Follow-up will continue through 24 weeks post-op.
Detailed Description:
The primary endpoint is femoral broaching time (in minutes), which is collected intraoperatively. The primary objective is to demonstrate that femoral broaching time with KINCISE is non-inferior to femoral broaching time with manual instruments (not using KINCISE) when used in THA with Anterior Advantage.
Note: If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of femoral broaching time will be conducted.
If the primary endpoint analysis successfully demonstrates non-inferiority of femoral broaching time, then the following three secondary objectives will be assessed with formal hypotheses, in order, under a gatekeeping strategy:
* Non-inferiority of skin-to-skin OR time when KINCISE is used vs. when KINCISE is not used.
* Non-inferiority of the percent of subjects with optimal acetabular cup abduction angle when KINCISE is used vs. when KINCISE is not used.
* Non-inferiority of the percent of subjects with optimal acetabular cup version angle when KINCISE is used vs. when KINCISE is not used.
In addition, the following secondary endpoints do not have prospectively planned hypotheses; these will be summarized for both treatment groups:
* Harris Hip Score (HHS) and HHS change from preoperative baseline
* Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline
* EQ-5D-5L and changes in these assessments from preoperative baseline
* Pain (Groin, Thigh, and Buttock)
* Patient Satisfaction
* Post-op time when functional activities can be accomplished (return to work, self-care, etc.)
* Radiographic Outcomes (based upon AP Hip, AP Pelvis, and Lateral)
* Length of hospital stay after index THA
* Re-hospitalizations during the study (including a specific summary of re-hospitalizations within 90 days)
* Narcotic drug usage throughout the study (participant reported)
* Complications (including a specific summary of complications within 90 days post-surgery)
Note: If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of femoral broaching time will be conducted.
If the primary endpoint analysis successfully demonstrates non-inferiority of femoral broaching time, then the following three secondary objectives will be assessed with formal hypotheses, in order, under a gatekeeping strategy:
* Non-inferiority of skin-to-skin OR time when KINCISE is used vs. when KINCISE is not used.
* Non-inferiority of the percent of subjects with optimal acetabular cup abduction angle when KINCISE is used vs. when KINCISE is not used.
* Non-inferiority of the percent of subjects with optimal acetabular cup version angle when KINCISE is used vs. when KINCISE is not used.
In addition, the following secondary endpoints do not have prospectively planned hypotheses; these will be summarized for both treatment groups:
* Harris Hip Score (HHS) and HHS change from preoperative baseline
* Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline
* EQ-5D-5L and changes in these assessments from preoperative baseline
* Pain (Groin, Thigh, and Buttock)
* Patient Satisfaction
* Post-op time when functional activities can be accomplished (return to work, self-care, etc.)
* Radiographic Outcomes (based upon AP Hip, AP Pelvis, and Lateral)
* Length of hospital stay after index THA
* Re-hospitalizations during the study (including a specific summary of re-hospitalizations within 90 days)
* Narcotic drug usage throughout the study (participant reported)
* Complications (including a specific summary of complications within 90 days post-surgery)
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?:
False
Is an FDA AA801 Violation?: