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NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty

NCT07595510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

  • Total Hip Arthroplasty (THA)
  • Hip Osteoarthritis

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Lodz University of Technology

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07595510 on ClinicalTrials.gov