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Veiligheid en effectiviteit van de HIT Reverse HRS

16 september 2026 bijgewerkt door: Hip Innovation Technology

Veiligheid en effectiviteit van het Hip Innovation Technology Reverse Hip Replacement System bij primaire totale heupartroplastiek: een cruciale 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

288

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Florida
      • Miami, Florida, Verenigde Staten, 33186
        • Werving
        • Miami Institute for Joint Reconstruction
        • Hoofdonderzoeker:
          • Arturo Corces
        • Contact:
      • Tampa, Florida, Verenigde Staten, 33614
        • Werving
        • Advent Health Hospital, Carrollwood
        • Contact:
        • Hoofdonderzoeker:
          • Steven Lyons
      • Tampa, Florida, Verenigde Staten, 33615
        • Werving
        • Tampa General Health / Florida Orthopedic Institute
        • Contact:
        • Hoofdonderzoeker:
          • Michael Miranda, DO
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21215
        • Beëindigd
        • LifeBridge Health Rubin Institute for Advanced Orthopedics
    • New Jersey
      • Somers Point, New Jersey, Verenigde Staten, 08244
    • Ohio
      • New Albany, Ohio, Verenigde Staten, 43054

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.

Andere namen:
  • HIT Omgekeerde HRS
Actieve vergelijker: 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.
Apparaat: 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
Andere namen:
  • Depuy Synthes Corail® of Depuy Synthes Actis ™ Totaal heupsysteem in combinatie met Depuy Synthes Pinnacle ™ compleet acetabulair heupsysteem
  • Zimmer Biomet TaperLoc® of Zimmer Biomet Avenir® compleet heupsysteem in combinatie met Zimmer Biomet G7® Acetabulair systeem
  • Stryker Acolade® II Femorale stengel in combinatie met Stryker Trident® II Acetabular Cup
  • Smith & neef Anthology® Totaal heupsysteem in combinatie met Smith & Nephew R3® Acetabular System
  • Zimmer Z1 ™ Cementless femorale heupstamsysteem

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
OHS of 36 or more at the 2-year follow-up visit
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 24 months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in OHS compared to baseline at all follow-up visits.
Tijdsspanne: 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.
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Exploratory Endpoints: OHS at all follow-up visits
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hip Innovation Technology

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 juli 2022

Primaire voltooiing (Geschat)

16 september 2030

Studie voltooiing (Geschat)

16 september 2038

Studieregistratiedata

Eerst ingediend

20 april 2022

Eerst ingediend dat voldeed aan de QC-criteria

27 april 2022

Eerst geplaatst (Werkelijk)

2 mei 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 september 2026

Laatste update ingediend die voldeed aan QC-criteria

16 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HIT-002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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