Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Bezpečnost a účinnost HIT Reverse HRS

16. září 2026 aktualizováno: Hip Innovation Technology

Bezpečnost a účinnost technologie inovace kyčle Reverzní systém náhrady kyčle u primární totální endoprotézy kyčle: stěžejní studie

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

288

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Florida
      • Miami, Florida, Spojené státy, 33186
        • Nábor
        • Miami Institute for Joint Reconstruction
        • Vrchní vyšetřovatel:
          • Arturo Corces
        • Kontakt:
      • Tampa, Florida, Spojené státy, 33614
        • Nábor
        • Advent Health Hospital, Carrollwood
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Steven Lyons
      • Tampa, Florida, Spojené státy, 33615
        • Nábor
        • Tampa General Health / Florida Orthopedic Institute
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Michael Miranda, DO
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21215
        • Ukončeno
        • LifeBridge Health Rubin Institute for Advanced Orthopedics
    • New Jersey
      • Somers Point, New Jersey, Spojené státy, 08244
    • Ohio
      • New Albany, Ohio, Spojené státy, 43054

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

50 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.

Ostatní jména:
  • HIT Reverzní HRS
Aktivní komparátor: 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.
Přístroj: 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
Ostatní jména:
  • DePuy Synthes Corail® nebo DePuy Synthes Actis ™ Total Hip System v kombinaci s DePuy Synthes Pinnacle ™ Kompletní acetabulární hip systém
  • Zimmer Biomet Taperloc® nebo Zimmer Biomet Avenir® Complete Hip System v kombinaci se Zimmer Biomet G7® Acetabular System
  • STRYKER Accolade® II FEMORAL STEM v kombinaci s acetabulárním šálkem Stryker Trident® II
  • Smith & Nephew Anthology® Celkový systém kyčle v kombinaci s acetabulárním systémem Smith & Nephew R3®
  • Zimmer Z1 ™ Cementless Femoral Hip Stonovy systém

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
OHS of 36 or more at the 2-year follow-up visit
Časové okno: 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.
Časové okno: 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
Časové okno: 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
Časové okno: 24 months

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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in OHS compared to baseline at all follow-up visits.
Časové okno: 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.
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Exploratory Endpoints: OHS at all follow-up visits
Časové okno: 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.
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hip Innovation Technology

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. července 2022

Primární dokončení (Odhadovaný)

16. září 2030

Dokončení studie (Odhadovaný)

16. září 2038

Termíny zápisu do studia

První předloženo

20. dubna 2022

První předloženo, které splnilo kritéria kontroly kvality

27. dubna 2022

První zveřejněno (Aktuální)

2. května 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • HIT-002

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit