Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
288 participants
INTERVENTIONAL
2022-07-15
2035-07-15
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Hip Innovation Technology Reverse Hip Replacement System
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.
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.
Already-marketed semi-constrained uncemented hip systems using a metal-on-XLPE or ceramic-on-XLPE bearing combination.
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
Interventions
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Hip Innovation Technology Reverse Hip Replacement System
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Patient has any condition that would interfere with self-assessment of pain, function, or quality of life (QoL) required for patient-reported outcomes during the study (based on the Investigator's judgment).
* Patient has a Body Mass Index (BMI) of 40 or higher.
* Patient has an active infection (e.g., hepatitis, Acquired Immune Deficiency Syndrome (AIDS), AIDS-related Complex (ARC)) that is systemic or at the site of the intended surgery.
* Patient is currently participating in any investigational study not related to this study's preoperative or postoperative care.
* Patient is currently pregnant or is planning to become pregnant during the study.
* Patient is a competitive or professional athlete.
50 Years
75 Years
ALL
No
Sponsors
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Hip Innovation Technology
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Anne Meredith Baldy
Role: primary
Anne Meredith Baldy
Role: primary
Taj-Jamal Andrews
Role: primary
Stephen Zabinski
Role: primary
Valerie Paul
Role: backup
David A Crawford, MD
Role: primary
Michael Sneller
Role: backup
References
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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.
Other Identifiers
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HIT-002
Identifier Type: -
Identifier Source: org_study_id