NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty (NCT07595510) | Clinical Trial Compass
CompletedNot Applicable
NaviFast 6D for Limb Length Measurement During Total Hip Arthroplasty
Poland84 participantsStarted 2023-05-09
Plain-language 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.
Who can participate
Age range
20 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a device called NaviFast 6D to measure leg length during hip replacement surgery — can you explain how this technology compares to what you currently use to check leg length balance during my procedure?
2Since the trial is already completed and was measuring accuracy of leg length discrepancy after hip replacement, has the data been published yet, and does it suggest this device performs better than standard methods?
3Leg length discrepancy after total hip replacement can affect walking and cause pain — how do you currently ensure my legs will be the same length after surgery, and is the approach used in this trial something your team has adopted?
4This was listed as a device accuracy study rather than a drug or surgical technique trial — does that mean the main risk I'd be evaluating is whether leg length is measured correctly, and how significant a concern is leg length difference in my specific case?
5Given that this trial has finished, would its findings change anything about my surgical plan, or is standard hip replacement at this point still the most straightforward option worth discussing first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of NaviFast 6D Measurement of Lower Limb Length Change
Timeframe: 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
2
Postoperative Leg Length Discrepancy Compared With Control Group
Timeframe: At postoperative pelvic radiographic assessment, an average of 1 day after surgery