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Safety and Effectiveness of the Hip Innovation Technology Reverse Hip Replacement System in Primary Total Hip Arthroplasty: A Pivotal Study
The purpose of this study is to determine if the use of the HIT Reverse Hip Replacement System is safe and effective in patients undergoing total hip replacement. We will determine whether it is safe and effective by comparing it to the control devices.
This is a randomized, controlled, multi-center clinical trial. Subjects meeting inclusion and exclusion criteria will be recruited from patients undergoing primary THA at up to 20 investigational sites. Subjects in the Experimental Arm will receive the Investigational Device. Subjects in the Control Arm will receive one of the already-marketed semi constrained uncemented hip systems using a metal on highly cross-linked polyethylene (XLPE) or ceramic-on-XLPE bearing combination. The following hip systems will be eligible for subjects in the Control Arm: * DePuy Synthes CORAIL® or DePuy Synthes ACTIS™ Total Hip System in combination with DePuy Synthes PINNACLE™ Complete Acetabular Hip System; * Zimmer Biomet Taperloc®, Zimmer Z1™ Cementless Femoral Hip Stem System or Zimmer Biomet AVENIR® Complete Hip System in combination with Zimmer Biomet G7® Acetabular System; * Stryker Accolade® II femoral stem in combination with Stryker Trident® II acetabular cup; * Smith \& Nephew ANTHOLOGY® Total Hip System in combination with Smith \& Nephew R3® Acetabular System. Surgery, post-surgical care, and rehabilitation will be per standard of care (SOC) for both arms.
Age
50 - 75 years
Sex
ALL
Healthy Volunteers
No
Miami Institute for Joint Reconstruction
Miami, Florida, United States
Advent Health Hospital, Carrollwood
Tampa, Florida, United States
Tampa General Health / Florida Orthopedic Institute
Tampa, Florida, United States
LifeBridge Health Rubin Institute for Advanced Orthopedics
Baltimore, Maryland, United States
Division of Orthopaedic Surgery
Somers Point, New Jersey, United States
JIS Orthopedics
New Albany, Ohio, United States
Start Date
July 15, 2022
Primary Completion Date
July 15, 2026
Completion Date
July 15, 2035
Last Updated
December 8, 2025
288
ESTIMATED participants
Hip Innovation Technology Reverse Hip Replacement System
DEVICE
Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
DEVICE
Lead Sponsor
Hip Innovation Technology
NCT07267793
NCT06792539
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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