Safety and Effectiveness of the HIT Reverse HRS

NCT05357378 | Recruiting DMC FDA Device

• 1 other identifier: HIT-002
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

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

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (4)

• OHS of 36 or more at the 2-year follow-up visit

  The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).

  24 months

• Change in OHS of 12 or more at the 2-year follow-up visit compared to baseline.

  The Oxford Hip Score (OHS) is a 12-item patient-reported outcome measure designed and developed to assess function and pain in patients undergoing hip replacement surgery. It ranges from 0 (poor) to 48 (best).

  24 months

• Radiologic success at the 2-year follow-up

  Defined as * No radiolucencies greater than 2 mm in 50% or more of the cup or stem zones; * No femoral or acetabular subsidence greater than or equal to 5 mm from baseline; * No acetabular cup inclination change greater than 4 degrees from baseline.

  24 months

• Absence of revision at the 2-year follow-up visit

  No reoperations that led to removal or replacement of any of the acetabular or femoral components.

  24 months

Secondary Outcomes (2)

• Change in OHS compared to baseline at all follow-up visits.

  24 months

• Change in HHS compared to baseline at all follow-up visits.

  24 months

Other Outcomes (6)

• Exploratory Endpoints: OHS at all follow-up visits

  10 year

• Exploratory Endpoints: HHS sub-scores (Pain, Function, Absence of Deformity, Range of Motion) at all follow-up visits.

  10 year

• Exploratory Endpoints: Device survivorship

  10 year

Study Arms (2)

Experimental Arm - HIT Reverse HRS

EXPERIMENTAL

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.

Device: Hip Innovation Technology Reverse Hip Replacement System

Control Arm

ACTIVE COMPARATOR

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.

Device: Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.

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.

Also known as: HIT Reverse HRS

Experimental Arm - HIT Reverse HRS

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

Also known as: DePuy Synthes CORAIL® or DePuy Synthes ACTIS™ Total Hip System in combination with DePuy Synthes PINNACLE™ Complete Acetabular Hip System, Zimmer Biomet Taperloc® 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, Zimmer Z1™ Cementless Femoral Hip Stem System

Control Arm

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requires primary THA due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, posttraumatic arthritis, slipped capital epiphysis, fracture of the pelvis, and diastrophic variant requiring unilateral primary THA.
• Patient is between 50 (inclusive) and 75 (inclusive) years of age at the time of enrollment.
• Patient has preoperative medical clearance and is free from or treated for medical conditions that would pose excessive operative risk.
• Patient has a signed and dated Informed Consent Form (ICF).
• Patient is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures and questionnaires.

You may not qualify if:

• Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip in the last 24 months.
• Patient has received earlier THA, hemi-arthroplasty, or fusion in the contralateral hip more than 24 months ago and has a contralateral hip-specific pain rating of ≥2 on a Numeric Rating Scale 0-10.
• Patient needs bilateral hip replacement or has a planned THA on the contralateral hip joint in the next 24 months.
• Patient needs knee arthroplasty or has a planned total knee arthroplasty in the next 24 months.
• Patient has a known allergy to titanium and/or XLPE.
• Patient has known metal sensitivities to cobalt chromium (CoCr).
• Patient has a history of septic arthritis in the index joint.
• Patient has insufficient acetabular or femoral bone stock in which good anchorage of the implants is unlikely or impossible.
• Patient has total or partial absence of the muscular or ligamentous apparatus.
• Patient has known moderate to severe renal insufficiency.
• Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease in either leg (based on the Investigator's judgment).
• Patient has a deformity of the affected limb or significant anatomic variance of the affected hip.
• Patient has an active malignancy or history of invasive malignancy within the last 5 years, except for superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix definitively treated more than 1 year prior to enrollment may enter the study.
• Patient has Paget's disease, Charcot-Marie-Tooth disease, or osteomalacia.
• Patient has an inflammatory DJD including any of its composite diagnoses: rheumatoid arthritis, systemic lupus erythematosus, pigmented villonodular synovitis, juvenile rheumatoid arthritis, and other arthritic processes of inflammatory or autoimmune etiology.

Sponsors & Collaborators

• Hip Innovation Technology: lead

Study Sites (6)

Miami Institute for Joint Reconstruction

Miami, Florida, 33186, United States

RECRUITING

Advent Health Hospital, Carrollwood

Tampa, Florida, 33614, United States

RECRUITING

Tampa General Health / Florida Orthopedic Institute

Tampa, Florida, 33615, United States

RECRUITING

LifeBridge Health Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, 21215, United States

RECRUITING

Division of Orthopaedic Surgery

Somers Point, New Jersey, 08244, United States

RECRUITING

JIS Orthopedics

New Albany, Ohio, 43054, United States

RECRUITING

Related Publications (1)

• Singh JA, Schleck C, Harmsen S, Lewallen D. Clinically important improvement thresholds for Harris Hip Score and its ability to predict revision risk after primary total hip arthroplasty. BMC Musculoskelet Disord. 2016 Jun 10;17:256. doi: 10.1186/s12891-016-1106-8.

  PMID: 27286675 BACKGROUND

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Osteoarthritis; Arthritis; Rheumatic Diseases

Central Study Contacts

George Diamantoni

CONTACT

1-866-832-4471; g.diamantoni@hit-irh.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2035
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)