NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty

NCT07595510 | Completed

• 2 other identifiers: PBK 1.3POIR.01.01.01-00-0290/21
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

NaviFast 6D; Leg Length Discrepancy; Intraoperative Measurement; Total Hip Arthroplasty; Radiographic Measurement; Hip Offset

Outcome Measures

Primary Outcomes (2)

• Accuracy of NaviFast 6D Measurement of Lower Limb Length Change

  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

  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

Secondary Outcomes (3)

• Accuracy of Radiographic Reference Measurement Using LLDcalc.com

  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

  During the surgical procedure

• Adverse Events and Device Deficiencies Associated With NaviFast 6D

  From the start of the surgical procedure through postoperative Day 2

Study Arms (2)

NaviFast 6D Measuring Arm

EXPERIMENTAL

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.

Device: NaviFast 6D Measuring Arm

Conventional Clinical Assessment

ACTIVE COMPARATOR

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

Interventions

NaviFast 6D Measuring Arm DEVICE

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.

NaviFast 6D Measuring Arm

Conventional Clinical Assessment During Total Hip Arthroplasty PROCEDURE

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.

Conventional Clinical Assessment

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lodz University of Technology: lead

Study Sites (4)

Wojewódzki Szpital Zespolony im. L. Perzyny

Kalisz, Greater Poland Voivodeship, Poland

Location

Military Clinical Hospital in Lublin

Lublin, Lublin Voivodeship, Poland

Location

University Orthopaedic and Rehabilitation Hospital

Zakopane, Poland

Location

Pabianice Medical Center

Pabianice, Łódź Voivodeship, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Leg Length Inequality

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases, Developmental; Bone Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ireneusz Urbaniak, MD, PhD

  Wojewódzki Szpital Zespolony im. L. Perzyny

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking was used. Surgeons and study personnel were aware of whether NaviFast 6D was used during the procedure.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, controlled, open-label, non-randomized clinical investigation with two study groups: patients undergoing primary total hip arthroplasty with intraoperative use of the NaviFast 6D measuring arm and a control group undergoing total hip arthroplasty using conventional clinical assessment only. The device group included Phase I, in which device measurements did not guide surgical decisions, and Phase II, in which surgeons could use NaviFast 6D measurements when selecting implant components.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 19, 2026
• Study Start: May 9, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4)