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NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty (NaviFast6D)

14 mei 2026 bijgewerkt door: Lodz University of Technology

Orthopedic Miniature Measuring Arm for Assessing Selected Parameters During Total Hip Arthroplasty

This multicenter clinical investigation evaluated the NaviFast 6D orthopedic miniature measuring arm during total hip arthroplasty. NaviFast 6D is an intraoperative measuring device intended to help orthopedic surgeons assess changes in lower limb length and hip offset during surgery.

The study was conducted in adult patients undergoing primary total hip arthroplasty. It included two phases. In the first phase, the device was used to verify functionality, usability, and measurement accuracy without influencing surgical decisions. In the second phase, surgeons could use the intraoperative measurements provided by NaviFast 6D when selecting trial and final implant components.

The main objectives were to compare NaviFast 6D measurements with radiographic measurements of limb length change and to compare postoperative leg length discrepancy between patients treated with NaviFast 6D and a control group treated using conventional clinical assessment. The study also assessed the impact of device use on surgical time and recorded device-related and procedure-related safety events.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This was a multicenter, controlled, open-label, non-randomized clinical investigation of the NaviFast 6D orthopedic miniature measuring arm in patients undergoing primary total hip arthroplasty.

NaviFast 6D is an active, invasive surgical medical device with a measuring function. The device consists of pelvic and femoral fixation elements, an articulated measuring arm with motion sensors, and a microprocessor unit with a display. It is intended for professional use by orthopedic surgeons during total hip arthroplasty to provide intraoperative information on changes in lower limb length and hip offset relative to the pre-implantation state.

During the procedure, fixation elements were attached to the pelvis and femur using cannulated screws. The measuring arm connected the two fixation elements and recorded relative displacement in six degrees of freedom. A baseline measurement was taken before implantation. After preparation of the acetabulum and femur and placement of trial components, the measuring arm was used again to assess the change in limb length and offset. The surgeon could then consider these measurements before final implantation.

The clinical investigation was conducted in two phases. Phase I focused on verification of device functionality, safety, usability, optimization of the measurement procedure, and comparison of NaviFast 6D measurements with reference radiographic measurements. During Phase I, surgical decisions were based on standard clinical assessment rather than on the device measurements. Phase II evaluated use of the final device configuration in clinical practice, with surgeons allowed to use NaviFast 6D measurements when selecting implant components, unless clinical assessment contradicted the measurement.

The primary objective of Phase I was to determine the accuracy of NaviFast 6D measurements of limb length change and hip offset compared with radiographic reference measurements. The primary objective of Phase II was to compare postoperative leg length discrepancy in patients treated with NaviFast 6D with a control group treated using conventional clinical assessment only.

Secondary objectives included assessment of the accuracy of the radiographic reference measurement method using the LLDcalc.com software, estimation of the additional operative time associated with use of NaviFast 6D, and identification and classification of adverse events or device deficiencies associated with use of the measuring arm.

The study population consisted of adult patients undergoing primary total hip arthroplasty. Patients were enrolled at participating clinical centers in Poland. The overall study period covered recruitment, surgical procedures, and postoperative observation from May 9, 2023 to August 30, 2024.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

84

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.

Studie Locaties

  • Polen
      • Zakopane, Polen
        • University Orthopaedic and Rehabilitation Hospital
    • Greater Poland Voivodeship
      • Kalisz, Greater Poland Voivodeship, Polen
        • Wojewódzki Szpital Zespolony im. L. Perzyny
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen
        • Military Clinical Hospital in Lublin
    • Łódź Voivodeship
      • Pabianice, Łódź Voivodeship, Polen
        • Pabianice Medical Center

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

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Patients scheduled for primary total hip arthroplasty.
  • Male or female patients.
  • Age 20 to 85 years.
  • No previous surgical procedures in the affected hip joint.
  • Ability and willingness to provide informed consent for participation in the clinical investigation.

Exclusion Criteria:

  • Lack of informed consent to participate in the clinical investigation.
  • Pregnancy.
  • Femoral neck fracture.
  • Pertrochanteric femoral fracture.
  • Pseudarthrosis of the femoral neck.
  • Traumatic or post-traumatic changes of the proximal femur or acetabular region.
  • Bone neoplasm.
  • Bone infection.
  • Advanced osteoporosis.

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: Ander
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: NaviFast 6D Measuring Arm
Patients undergoing primary total hip arthroplasty with intraoperative use of the NaviFast 6D orthopedic miniature measuring arm. The device was used to measure changes in lower limb length and hip offset during surgery. In Phase I, measurements were recorded but did not guide surgical decisions. In Phase II, surgeons could use NaviFast 6D measurements when selecting trial and final implant components.
Apparaat: NaviFast 6D Measuring Arm
NaviFast 6D is an orthopedic miniature measuring arm used intraoperatively during total hip arthroplasty to measure changes in lower limb length and hip offset relative to the pre-implantation state. The device includes pelvic and femoral fixation elements, an articulated measuring arm with motion sensors, and a microprocessor unit with a display.
Actieve vergelijker: Conventional Clinical Assessment
Patients undergoing primary total hip arthroplasty using conventional intraoperative clinical assessment only, without use of the NaviFast 6D measuring arm. This group served as the control group for comparison of postoperative leg length discrepancy.
Procedure: Conventional Clinical Assessment During Total Hip Arthroplasty
Standard intraoperative clinical assessment used during primary total hip arthroplasty without use of the NaviFast 6D measuring arm. Assessment of limb length and hip biomechanics was based on the surgeon's conventional visual, palpatory, and clinical judgment during the procedure.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Accuracy of NaviFast 6D Measurement of Lower Limb Length Change
Tijdsspanne: Preoperative pelvic radiograph, an average of 1 day before surgery; intraoperative NaviFast 6D measurement during surgery; and postoperative pelvic radiograph, an average of 1 day after surgery
Accuracy of intraoperative lower limb length change measurement performed with the NaviFast 6D measuring arm, assessed by comparing NaviFast 6D measurements with reference radiographic measurements obtained from preoperative and postoperative pelvic radiographs analyzed using LLDcalc.com software. The endpoint was expressed as the root mean square difference between NaviFast 6D and radiographic measurements in millimeters.
Preoperative pelvic radiograph, an average of 1 day before surgery; intraoperative NaviFast 6D measurement during surgery; and postoperative pelvic radiograph, an average of 1 day after surgery
Postoperative Leg Length Discrepancy Compared With Control Group
Tijdsspanne: At postoperative pelvic radiographic assessment, an average of 1 day after surgery
Postoperative leg length discrepancy was compared between patients undergoing total hip arthroplasty with intraoperative use of NaviFast 6D and patients undergoing total hip arthroplasty using conventional intraoperative clinical assessment only. Leg length discrepancy was assessed on postoperative radiographs and expressed in millimeters.
At postoperative pelvic radiographic assessment, an average of 1 day after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Accuracy of Radiographic Reference Measurement Using LLDcalc.com
Tijdsspanne: At radiographic image analysis of paired preoperative or paired postoperative pelvic radiographs obtained in the same clinical state within approximately 1 to 3 months
Accuracy of the radiographic reference method for assessing leg length discrepancy and hip offset was evaluated using LLDcalc.com software. The analysis assessed the repeatability of measurements performed on radiographs obtained in the same clinical state and expressed results as root mean square differences in millimeters.
At radiographic image analysis of paired preoperative or paired postoperative pelvic radiographs obtained in the same clinical state within approximately 1 to 3 months
Additional Operative Time Associated With NaviFast 6D Use
Tijdsspanne: During the surgical procedure
Additional operative time associated with use of the NaviFast 6D measuring arm was estimated based on the time required for device fixation, intraoperative measurement procedures, and potential implant component adjustment based on device readings.
During the surgical procedure
Adverse Events and Device Deficiencies Associated With NaviFast 6D
Tijdsspanne: From the start of the surgical procedure through postoperative Day 2
Adverse events, serious adverse events, device deficiencies, and corrective actions associated with intraoperative use of the NaviFast 6D measuring arm were recorded and classified throughout the clinical investigation.
From the start of the surgical procedure through postoperative Day 2

Medewerkers en onderzoekers

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

Sponsor

Lodz University of Technology

Onderzoekers

  • Hoofdonderzoeker: Ireneusz Urbaniak, MD, PhD, Wojewódzki Szpital Zespolony im. L. Perzyny

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)

9 mei 2023

Primaire voltooiing (Werkelijk)

30 augustus 2024

Studie voltooiing (Werkelijk)

30 augustus 2024

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

14 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PBK 1.3
  • POIR.01.01.01-00-0290/21 (Ander subsidie-/financieringsnummer: National Centre for Research and Development)

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

Beschrijving IPD-plan

Individual participant data will not be shared because the dataset contains sensitive clinical and radiographic information, and no formal individual participant data sharing plan or participant consent for such sharing was defined in the study protocol. Aggregate results will be reported in publications.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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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