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Sécurité et efficacité du HIT Reverse HRS

16 septembre 2026 mis à jour par: Hip Innovation Technology

Sécurité et efficacité du système de remplacement inversé de la hanche de la technologie Hip Innovation dans l'arthroplastie totale primaire de la hanche : une étude pivotale

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

288

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Florida
      • Miami, Florida, États-Unis, 33186
        • Recrutement
        • Miami Institute for Joint Reconstruction
        • Chercheur principal:
          • Arturo Corces
        • Contact:
      • Tampa, Florida, États-Unis, 33614
        • Recrutement
        • Advent Health Hospital, Carrollwood
        • Contact:
        • Chercheur principal:
          • Steven Lyons
      • Tampa, Florida, États-Unis, 33615
        • Recrutement
        • Tampa General Health / Florida Orthopedic Institute
        • Contact:
        • Chercheur principal:
          • Michael Miranda, DO
    • Maryland
      • Baltimore, Maryland, États-Unis, 21215
        • Résilié
        • LifeBridge Health Rubin Institute for Advanced Orthopedics
    • New Jersey
      • Somers Point, New Jersey, États-Unis, 08244
        • Recrutement
        • Division of Orthopaedic Surgery
        • Contact:
        • Contact:
    • Ohio
      • New Albany, Ohio, États-Unis, 43054

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Dispositif: 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.

Autres noms:
  • HIT Reverse HRS
Comparateur actif: 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.
Dispositif: 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
Autres noms:
  • DePuy Synthes Corail® ou DePuy Synthes ACTI ™ Total Hip System en combinaison avec DePuy Synthes Pinnacle ™ Système complet de la hanche acétabulaire
  • Zimmer Biomet Taperloc® ou Zimmer Biomet Avenir® Système de hanche complet en combinaison avec le système acétabulaire Zimmer Biomet G7®
  • Stryker Accolade® II STEME fémorale en combinaison avec la tasse acétabulaire Stryker Trident® II
  • Smith & Nephew Anthology® Total Hip System en combinaison avec Smith & Nephew R3® Système acétabulaire
  • Système de tige de hanche fémorale sans ciment Zimmer Z1 ™

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
OHS of 36 or more at the 2-year follow-up visit
Délai: 24 months

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.
Délai: 24 months

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
Délai: 24 months

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
Délai: 24 months

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in OHS compared to baseline at all follow-up visits.
Délai: 24 months

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 HHS compared to baseline at all follow-up visits.
Délai: 24 months

The Harris Hip Score (HHS) is a clinician-based 10-item questionnaire used to evaluate the results of hip surgery. It is comprised of 4 sub-sections yielding a maximum possible score of 100 points collectively, including pain (44 points), function (47 points), absence of deformity (4 points), and range of motion (5 points).

Measured as Cohen's effect size, the improvements of THA are in the range of 3 and higher (Singh et al., 2016). The traditional categorization of HHS is: < 70, poor; 70-79, fair; 80-89, good; and 90-100, excellent.
24 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Exploratory Endpoints: OHS at all follow-up visits
Délai: 10 year

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).
10 year
Exploratory Endpoints: HHS sub-scores (Pain, Function, Absence of Deformity, Range of Motion) at all follow-up visits.
Délai: 10 year

The Harris Hip Score (HHS) is a clinician-based 10-item questionnaire used to evaluate the results of hip surgery. It is comprised of 4 sub-sections yielding a maximum possible score of 100 points collectively, including pain (44 points), function (47 points), absence of deformity (4 points), and range of motion (5 points).

Measured as Cohen's effect size, the improvements of THA are in the range of 3 and higher (Singh et al., 2016). The traditional categorization of HHS is: < 70, poor; 70-79, fair; 80-89, good; and 90-100, excellent.
10 year
Exploratory Endpoints: Device survivorship
Délai: 10 year

Device survivorship is measured as a cardinal event. Any reoperation in which the entire device or part of the device has been removed or replaced will be defined as a device revision.
10 year
Exploratory Endpoints: Radiographic evaluation of linear penetration of the femoral head at the 2-year follow-up visit.
Délai: 10 year

This study requires anteroposterior (AP)-pelvis and lateral (frog-leg or Lauenstein position) views obtained in the supine position on all subjects. An additional AP-hip image will be needed only if the AP-pelvis cannot provide a complete implant image. Radiographs will be obtained at the immediate postoperative follow-up (AP-pelvis only), and at the 6-week, 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, and 10-year follow-up visits. Radiographs will be transferred to the Central Radiology Lab for processing and evaluation by an independent radiologist.
10 year
Exploratory Endpoints: Metal ion level assessment of titanium, cobalt, and chromium.
Délai: 10 year

All subjects will have baseline metal ion level (Ti, Co, and Cr) identified before study THA. Further, all subjects will be monitored for metal ions (Ti, Co, and Cr) at 1-, 2-, 3-, 4-, 5-, 7-, and 10-year follow-up visits.
10 year
Exploratory Endpoints: Subject Satisfaction with Outcome.
Délai: 10 year

Subject Satisfaction with Outcome will be evaluated at the 1, 2-, 3-, 4- 5-, 7- and 10-year follow-up visits using a 4-point ordinal scale. The questionnaire will ask subjects how satisfied they are with the outcome of the surgery. The available answers will include: Very Satisfied (4); Somewhat Satisfied (3); Somewhat Dissatisfied (2); and Very Dissatisfied (1).
10 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hip Innovation Technology

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 juillet 2022

Achèvement primaire (Estimé)

16 septembre 2030

Achèvement de l'étude (Estimé)

16 septembre 2038

Dates d'inscription aux études

Première soumission

20 avril 2022

Première soumission répondant aux critères de contrôle qualité

27 avril 2022

Première publication (Réel)

2 mai 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HIT-002

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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