Anterior Advantage With KINCISE
NCT04191733 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2023-09-15
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.
Conditions
- Rheumatoid Arthritis
- Osteoarthritis
- Post Traumatic Arthritis
Interventions
- DEVICE
-
KINCISE(TM) Surgical Automated System
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System
Sponsors & Collaborators
-
DePuy Orthopaedics
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-28
- Primary Completion
- 2022-07-13
- Completion
- 2022-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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