Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT04191733
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)
Study:
NCT04191733
Study Brief:
Protocol Section:
NCT04191733