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NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty
Sponsor: Lodz University of Technology
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.
Official title: Orthopedic Miniature Measuring Arm for Assessing Selected Parameters During Total Hip Arthroplasty
Key Details
Gender
All
Age Range
20 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2023-05-09
Completion Date
2024-08-30
Last Updated
2026-05-19
Healthy Volunteers
No
Interventions
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.
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.
Locations (4)
Wojewódzki Szpital Zespolony im. L. Perzyny
Kalisz, Greater Poland Voivodeship, Poland
Military Clinical Hospital in Lublin
Lublin, Lublin Voivodeship, Poland
University Orthopaedic and Rehabilitation Hospital
Zakopane, Poland
Pabianice Medical Center
Pabianice, Łódź Voivodeship, Poland