Safety and Effectiveness of the HIT Reverse HRS

Conditions

• Avascular Necrosis of Hip
• Degenerative Joint Disease
• Osteoarthritis, Hip
• Traumatic Arthropathy-Hip

Eligibility Criteria

Sex

ALL

Age

50 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Hip Innovation Technology Reverse Hip Replacement System — DEVICE
  Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
• Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. — DEVICE
  Control Arm subjects will receive one of the already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination. * 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

Study Details

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.

Key Dates

Start date

Jul 15, 2022

Status verified

May 2026

Primary completion

Jul 15, 2026

Completion

Jul 15, 2035

Study Design

Enrollment

288 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm - HIT Reverse HRS
  Subjects in the Experimental Arm will receive the HIT Reverse HRS Investigational Device. Implantation of the Investigational Device is performed using standard surgical procedures for THA, as described in the Instructions for Use (IFU). The control hip systems will be implanted in accordance with their respective IFU, which are also in line with standard surgical approaches for THA.
• Active Comparator: Control Arm
  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.

Primary Outcome Measure

OHS of 36 or more at the 2-year follow-up visit [ Time Frame: 24 months ]

Central Contacts

• George Diamantoni
  1-866-832-4471
  [email protected]

Locations (6)

Find similar trials in Miami, FL

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