NCT04191733

Anterior Advantage With KINCISE

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: DePuy Orthopaedics · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Post Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	KINCISE(TM) Surgical Automated System	Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System

Timeline

• Start date: 2020-01-28
• Primary completion: 2022-07-13
• Completion: 2022-08-31
• First posted: 2019-12-10
• Last updated: 2023-09-15
• Results posted: 2023-09-15

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study