Efficacy and Safety of NAVIO

NCT04230616 | Recruiting FDA Device

• 1 other identifier: S63149
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (20)

• Difference in planned and achieved alignment in degrees based on CT scan pre- and postoperatively (first 52 participants)

  Difference in preoperatively planned and postoperatively achieved alignment of both the femoral and tibial component of the prosthesis in the frontal, sagittal and coronal plane. Deviations (in degrees varus/valgus, flexion extension, and internal/external rotation) from calculated positions (of both components) to bony anatomic landmarks, used by NAVIO to align the prosthesis, will be obtained.

  within 6 weeks pre-surgery and 6 weeks post-surgery

• Difference in planned and achieved mechanical axis in degrees based on CT scan pre- and postoperatively (first 52 participants)

  Preoperatively planned and postoperatively achieved mechanical axis of the operated leg. The mechanical axis is defined as the angle between a line from the centre of rotation of the hip to the centre of the femoral component and a line from the centre of the tibial plateau to the centre of the ankle.

  within 6 weeks pre-surgery and 6 weeks post-surgery

• Difference in percentage of outliers of alignment on CT scan pre- and postoperatively (first 52 participants)

  Percentage of outliers in alignment (defined as \> 3 degrees deviation from positions calculated by software) of the femoral and tibial components in frontal, sagittal and transverse plane.

  within 6 weeks pre-surgery and 6 weeks post-surgery

• Difference in percentage of outliers of mechanical axis based on CT scan pre- and postoperatively (first 52 participants)

  Percentage of outliers (defined as \> 3 degrees deviation from neutral) in mechanical axis of the of the operated leg. The mechanical axis is defined as the angle between a line from the centre of rotation of the hip to the centre of the femoral component and a line from the centre of the tibial plateau to the centre of the ankle.

  within 6 weeks pre-surgery and 6 weeks post-surgery

• Mean change in the visual analogue scale scores

  Comparison is made between the two study arms, a higher visual analogue pain score means a worse outcome

  within 6 weeks preoperative, 24 hours post-surgery, day of discharge, 6 weeks post-surgery, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery

• Mean change in the American Knee Society Score

  in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points . Comparison is made between the two study arms. A higher American Knee Society Score means a better outcome

  within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery

• Mean change in the Oxford Knee Score

  Comparison is made between the two study arms, score between 0 and 48. Better score means better outcome

  within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery

• Mean change in the Lower Extremities Activity scale

  Comparison is made between the two study arms, score between 0 and 80. The minimal clinically important difference is 9 scale points. The lower the score the greater the disability.

  within 6 weeks preoperative, day of discharge, 6 weeks post-surgery, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery

• Mean change in the The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Comparison is made between the two study arms. Five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). The higher the score, the poorer the function

  within 6 weeks preoperative, 3 months post-surgery, 1 year post-surgery, 2 years post-surgery, 5 years post-surgery, 10 years post-surgery

• Difference in mechanical axis of the prosthesis between the two study arms based on Long-leg X-rays

  Post-operative (at 6 week visit) the baseline mechanical axis will be measured as the angle between a line connecting the center of the femoral head with the center of the knee and the line connecting the center of the knee with the center of the ankle.

  within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery

• Difference in positioning of the prosthesis between the two study arms based on Long-leg X-rays

  In order to measure positioning of the prosthesis (coronal alignment), long-leg, weight-bearing, standing anteroposterior and lateral X-rays will be made

  within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery

• Difference in wear between the two study arms based on Long-leg X-rays

  In the long term, wear can be roughly measured by measuring again the mechanical axis of the leg and comparing this with baseline mechanical axis and by measuring the distance between medial and lateral femoral condyles and medial and lateral tibial platform respectively.

  within 6 weeks preoperative, 6 weeks post-surgery, 1 year post-surgery, 5 years post-surgery, 10 years post-surgery

• Significant difference in length of hospital stay between the two study arms

  Length of hospital stay (in days) will be registered for both groups.

  1 day of discharge from the hospital

• Operation Time

  Compare the duration of surgery between the two study arms

  intraoperative (Time will be recorded from the moment of incision until bandage is being placed)

• Significant difference in blood loss between study arms

  Blood loss will be measured intra-operatively and up to 24 hours post-operatively. The amount of rinsing liquid will be subtracted from the total amount collected in the suction device to obtain the amount (ml) of intra-operative blood loss. The weight of grids and compresses will be measured post-operatively and dry weight will be subtracted from this value to obtain blood loss not collected in the suction device (1mg = 1ml). On day 2 post-operative, Hb and Ht will obtained.

  Intra-operatively until 24 hours post-surgery. .

• Difference in adverse events

  Complication registration will be done throughout the entire study period

  through study completion, an average of 10 years

• Difference in frequency of infection

  When infection is present, this will be noted on the complication registry form and appropriate action will be taken. Distinction will be made between superficial infections and deep infections.

  through study completion, an average of 10 years

• Difference in frequency of trombo-embolic complications

  Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism.

  through study completion, an average of 10 years

• Difference in frequency of wound problems

  Persistent wound leakage will be registered. Persistent leakage is defined as leakage lasting 5 days after surgery.

  From day of surgery until 5 days post-surgery

• Difference in frequency of loosening

  Loosening of tibial or femoral components of the prosthesis as seen on X-ray.

  through study completion, an average of 10 years.

Study Arms (2)

Conventional total knee arthroplasty

ACTIVE COMPARATOR

conventional total knee arthroplasty with standard intramedullary alignment guide

Procedure: total knee arthroplasty; Radiation: CT scan

NAVIO total knee arthroplasty

ACTIVE COMPARATOR

NAVIO assisted total knee arthroplasty

Procedure: total knee arthroplasty; Radiation: CT scan

Interventions

total knee arthroplasty PROCEDURE

total knee arthroplasty

Conventional total knee arthroplasty; NAVIO total knee arthroplasty

CT scan RADIATION

The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.

Conventional total knee arthroplasty; NAVIO total knee arthroplasty

Eligibility Criteria

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

You may qualify if:

• Painful and disabled knee joint resulting from osteoarthritis where one or more compartments are involved, as assessed by X-ray
• High need to obtain pain relief and improve function
• Above 18 years old
• Able and willing to follow instructions
• Informed consent

You may not qualify if:

• Active infection in knee
• General infection
• Failure of previous joint replacement
• Post-operative or post traumatic malalignment of the knee/leg
• Pregnancy
• Not able or willing to undergo CT-scan

Sponsors & Collaborators

• Sint-Trudo Hospital: lead

Study Sites (1)

Orthopaedic Association Sint-Trudo Hospital

Sint-Truiden, Limburg, 3800, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Peter Bollars, Dr.

  Orthopedic Association Sint-Trudo Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Bollars, Dr.

CONTACT

+3211 33 42 86; peter.bollars@stzh.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2022
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 18, 2021

Record last verified: 2020-10

Locations

BE (1)