Total Hip Arthroplasty (THA)NaviFast6DNCT07595510
NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty
A study testing NaviFast 6D Measuring Arm and Conventional Clinical Assessment During Total Hip Arthroplasty in people with Total Hip Arthroplasty (THA) and Hip Osteoarthritis, run by Lodz University of Technology at 4 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Total Hip Arthroplasty (THA), Hip Osteoarthritis
- What is being tested?
- NaviFast 6D Measuring Arm and Conventional Clinical Assessment During Total Hip Arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 4 sitesPoland
- Study dates
- 9 May 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Bone neoplasm.
- Bone infection.
- Advanced osteoporosis.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Wojewódzki Szpital Zespolony im. L. Perzyny
Kalisz, Greater Poland Voivodeship
Military Clinical Hospital in Lublin
Lublin, Lublin Voivodeship
Pabianice Medical Center
Pabianice, Łódź Voivodeship
University Orthopaedic and Rehabilitation Hospital
Zakopane
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Total Hip Arthroplasty (THA), Hip Osteoarthritis
- Being tested
- NaviFast 6D Measuring Arm, Conventional Clinical Assessment During Total Hip Arthroplasty
- Keywords
- NaviFast 6D, Leg Length Discrepancy, Intraoperative Measurement, Total Hip Arthroplasty, Radiographic Measurement, Hip Offset
- Medical subject headings
- Osteoarthritis, Hip, Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviFast 6D Measuring ArmDevice
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 ArthroplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Clinical Assessment During Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At postoperative pelvic radiographic assessment, an average of 1 day after surgery
Secondary outcomes (3)
Accuracy of Radiographic Reference Measurement Using LLDcalc.com
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.
Measured: 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
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.
Measured: During the surgical procedure
Adverse Events and Device Deficiencies Associated With NaviFast 6D
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.
Measured: From the start of the surgical procedure through postoperative Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start9 May 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lodz University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ireneusz Urbaniak, MD, PhD, Principal investigator, Wojewódzki Szpital Zespolony im. L. Perzyny
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595510
- Sponsor's protocol ID
- PBK 1.3
- Other IDs
- POIR.01.01.01-00-0290/21
- Acronym
- NaviFast6D
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthopedic Miniature Measuring Arm for Assessing Selected Parameters During Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07595510
- Acronym / sponsor ID
- NaviFast6D / PBK 1.3
- Conditions
- Total Hip Arthroplasty (THA), Hip Osteoarthritis
- Keywords
- NaviFast 6D, Leg Length Discrepancy, Intraoperative Measurement, Total Hip Arthroplasty, Radiographic Measurement, Hip Offset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Lodz University of TechnologyUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| NaviFast 6D Measuring Arm | Experimental | Device: NaviFast 6D Measuring ArmPatients 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. |
| Conventional Clinical Assessment | Active comparator | Procedure: Conventional Clinical Assessment During Total Hip ArthroplastyPatients 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Lack of informed consent to participate in the clinical investigation.
- Pregnancy.
- Femoral neck fracture.
- Pertrochanteric femoral fracture.
- Pseudarthrosis of the femoral neck.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaviFast 6D Measuring ArmNaviFast 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. | Device | NaviFast 6D Measuring Arm |
| Conventional Clinical Assessment During Total Hip ArthroplastyStandard 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. | Procedure or surgery | Conventional Clinical Assessment |
Primary outcome
Accuracy of NaviFast 6D Measurement of Lower Limb Length Change
Time frame: 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.
Postoperative Leg Length Discrepancy Compared With Control Group
Time frame: 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.
3 secondary outcomes
Accuracy of Radiographic Reference Measurement Using LLDcalc.com
Time frame: 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
Time frame: During the surgical procedure
Adverse Events and Device Deficiencies Associated With NaviFast 6D
Time frame: From the start of the surgical procedure through postoperative Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Total Hip Arthroplasty (THA)
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Enrolling by invitationPhase 2
Efficacy of Intravenous Oxytocin to Speed Recovery After THA
Total Hip Arthroplasty
Enrolling by invitationPhase 3
A Clinical Trial Evaluating the Efficacy and Safety of Local Infiltration of RF16001 for Injection for Analgesia After Total Hip Arthroplasty in China
Pain After Abdominal Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ireneusz Urbaniak, MD, PhD principal investigator
Wojewódzki Szpital Zespolony im. L. Perzyny
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NaviFast 6D Measuring Arm and Conventional Clinical Assessment During Total Hip Arthroplasty in people with Total Hip Arthroplasty (THA) and Hip Osteoarthritis, run by Lodz University of Technology at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of NaviFast 6D Measurement of Lower Limb Length Change (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.