Arthritis, DegenerativeNavioRCTNCT04525950
Robotized Navigation Compared to Conventional Technique in Total Knee Replacement
A study testing Navio and Conventional in people with Arthritis, Degenerative and Osteo Arthritis Knee, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
Navio is a new generation of computer navigation systems allowing intraoperative navigation of the bone cuts relative to both ligaments and skeletal axes, prior to bone removal. An improved accuracy is incorporated by the use of robotics in a burr for bone removal. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Arthritis, Degenerative, Osteo Arthritis Knee
- What is being tested?
- Navio and Conventional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 2 sitesNorway
- Study dates
- 7 Sep 2020to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Degenerative knee in need of a total knee arthroplasty
- Recruited from the hospital's waiting list
- Informed consent
Who cannot join
- Severe systemic illness
- Infections
- Severe neurological dysfunction
- Severe cancer disease
- Severe incompensated heart failure
- Severe incompensated lung disease
- Dementia
- Previous fracture or deformity of the limb, making the use of an intramedullary rod impossible (same side hip or ankle implant is not to be excluded if the rod unaffectedly reaches more than the first half of the femoral canal)
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland university hospital
Bergen, 5021
Haugesund sanitetsforenings revmatismesykehus
Haugesund, Haugesund, 5504
About this study
Official title: Robotized Computer Navigation Versus Conventional Technique in Total Knee Replacement. A Randomized, Clinical and Radiostereometric Trial.
Navio is a new generation of computer navigation systems allowing intraoperative navigation of the bone cuts relative to both ligaments and skeletal axes, prior to bone removal. An improved accuracy is incorporated by the use of robotics in a burr for bone removal.
This study investigates whether this advanced technology leads to better clinical or radiostereometric results, by comparing one group operated with Navio to another group operated with conventional technique.
Read the detailed description
Background:
The scientific foundation of total knee replacement (TKR) surgery is incomplete. As a national governor of joint replacements, the Norwegian Arthroplasty Register is obligated to strict regulations, demanding high levels of evidence for implants and instruments utilized by Norwegian surgeons. It is well known that 15-20% of patients with a TKR, are dissatisfied. Nevertheless, only a small proportion of these patients have revision surgery.
In this randomized, clinical trial we will use the Journey II BCS total knee system, with a more native anatomical design, intended to improve the kinematics and functional outcomes by mimicking a native knee, with respect to geometry and its interplay with the ligaments and soft tissue envelope of the knee (i.e. the biomechanics; stability, joint line, off-set, sizing etc.). To achieve an optimal placement of the implant, the surgeon needs to assess a lot of information (experience) during the surgical procedure. To secure this process, and to make sure all aspects are taken into account, with respect to an optimal positioning and ligament balancing, the computer navigation technique may offer valuable input, with further enhancement of the accuracy and precision using precision tools like the Navio from Smith \& Nephew. The Navio system combines robotics and computer navigation, and represents the newest technology within surgical robotics and haptics. This trial is important in the mandatory evaluation process needed, before introducing new technology into orthopaedic surgery, on a larger scale.
Methods:
The surgeons involved have been trained at a wet lab, and on saw bones, before utilizing this tool in a live setting. After the introduction period, the training will continue in a clinical setting until the surgeons have operated at least 20 Navio assisted cases each, followed by a pilot study of 10 patients. All patients will be randomized to either Navio or Conventional technique.
Surgical method: A tourniquet is used. All implant components are cemented (Palacos R+G bone cement is utilized 10 minutes after retrieval from a 4 degrees Celsius refrigerator). Standard para-patellar approach. ACL and PCL are removed. Closing of the wound and capsule in mid-flexion position, Quill for the capsule, Vicryl for the subcutaneous tissue, continuous overlapping mattress with Ethilon suture for the skin. No drainage. Wrapping of the entire limb with elastic dressings for the first 48 hours. Prophylactic antibiotics and anticoagulants are given. Tranexamic acid to reduce bleeding. Postop pain medication: gabapentin, acetaminophen, naproxen, femoral triangle nerve block (repeated next day if needed).
For the conventional group: The rotational alignment is set according to Whiteside's line, and intramedullary rods with 5, 6 or 7 degrees valgus, are selected for the distal femoral cut (dependent on pre-operatively measured angles on long radiographs (hip-knee-ankle). The entry hole of the rod is plugged with bone from the femur to reduce bleeding from the intramedullary canal. The tibial component (metal) is positioned with a 3 degrees posterior slope.
For the Navio group: The cuts are navigated to optimize ligament balance in flexion and extension, and adjusted for mid-flexion instability when needed. A difference of less than 4 mm between lateral and medial gaps is accepted when the laxity is on the lateral side, preferably in flexion. However, if the gap balancing technique suggests a deviation from mechanical alignment of more than 2 degrees of valgus or 4 degrees of varus, the suggestion is overruled by the mechanical alignment (maximum 2 degrees valgus, less than 4 degrees varus).
Sample size calculations: To detect a clinically important difference of 0.17 in the rate of "high responders" and "non-responders" (OMERACT-OARSI criteria) to the Navio, with a standard deviation of 20, power 80% and a 0.05 significance level, a total of 194 patients must be included in the trial (97 patients in each group). The calculations are based on data from a previous study, by Petursson et al, JBJS Am 2018. When 10% eventual drop-outs are taken into account, the total number of patients to be included is 214 (107 patients in each group).
A large number of patients is important, as the expected difference between the groups is small. A small difference may be less clinically relevant, however, may contribute to an overall better outcome for the patients in total. A small improvement of the tools combined with other small improvements may add up to be clinically important in the end. Small trials with no significant differences may disqualify important small improvements, thus stopping any further development in the field. Consequently, large clinical trials will be valuable.
A radiostereometric analysis constitutes a separate study of the trial. A clinically relevant difference of 0.1 mm between the groups will be detected with a standard deviation of 0.1, power 80% and significance level 0.05, if 17 patients are included in each group. Including eventual drop-outs and an expectation of some failures due to the technically challenging investigation method (the RSA), a total of 30 patients will be included in each group. RSA radiographs will be collected within the first week after the operation, at 3 months, 1 year, 2 years and 5 years follow-ups.
The trial is approved by the regional ethics committee and the data inspectorate of Norway.
- Conditions
- Arthritis, Degenerative, Osteo Arthritis Knee
- Being tested
- Navio, Conventional
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavioProcedure or surgery
New generation computer navigation with haptics and robotics
ConventionalProcedure or surgery
Total knee arthroplasty using conventional instruments
| Study group | Role | What they receive |
|---|---|---|
| Navio | Experimental | Using the new technology during surgery Receives: Procedure: Navio |
| Conventional | Active comparator | Using the conventional surgical instruments Receives: Procedure: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) high responders
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
Measured: 3 months
WOMAC high responders
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
Measured: 1 year
WOMAC high responders
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
Measured: 2 years
WOMAC high responders
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
Measured: 5 years
Radiostereometric migration
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
Measured: 1 year
Radiostereometric migration
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
Measured: 2 years
Radiostereometric migration
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
Measured: 5 years
Secondary outcomes (25)
Knee injury and osteoarthritis outcome score (KOOS)
Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0(worse)-100(better))
Measured: 3 months
Knee injury and osteoarthritis outcome score (KOOS)
Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)
Measured: 1 year
Knee injury and osteoarthritis outcome score (KOOS)
Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)
Measured: 2 years
Knee injury and osteoarthritis outcome score (KOOS)
Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)
Measured: 5 years
Knee society score (KSS)
Knee society score, knee score (0(worse)-100(better)) and function score (0(worse)-100(better))
Measured: 3 months
Knee society score (KSS)
Knee society score, knee score (0-100) and function score (0-100)
Measured: 1 year
Knee society score (KSS)
Knee society score, knee score (0-100) and function score (0-100)
Measured: 2 years
Knee society score (KSS)
Knee society score, knee score (0-100) and function score (0-100)
Measured: 5 years
EQ-5D
Euroqol, quality of life (0(worse)-100(better))
Measured: 3 months
EQ-5D
Euroqol, quality of life (0-100)
Measured: 1 year
EQ-5D
Euroqol, quality of life (0-100)
Measured: 2 years
EQ-5D
Euroqol, quality of life (0-100)
Measured: 5 years
Visual analogue scale (VAS)
Visual Analogue Scale pain (0(worse)-100(better))
Measured: pre-op, 3 months, 1 year, 2 years, 5 years
Forgotten Joint Score (FJS)
Forgotten Joint Score (0(worse)-100(better))
Measured: 3 months
Forgotten Joint Score (FJS)
Forgotten Joint Score (0-100)
Measured: 1 year
Forgotten Joint Score (FJS)
Forgotten Joint Score (0-100)
Measured: 2 years
Forgotten Joint Score (FJS)
Forgotten Joint Score (0-100)
Measured: 5 years
Maximum climb-up test
Height (cm) of one stair climbed with affected/operated limb (no pulling by hands)
Measured: 3 months
Maximum climb-up test
Height (cm) of one stair climbed with affected/operated limb (no pulling by hands)
Measured: 1 year
Anchor questions
Are you satisfied with the outcome? Would you do it again?
Measured: 2 years
Anchor questions
Are you satisfied with the outcome? Would you do it again?
Measured: 5 years
Timed 40 meters walking test
Time spent walking 40 meters
Measured: 3 months
Timed 40 meters walking test
Time spent (in seconds) walking 40 meters
Measured: 1 year
Chair test 30 seconds
number of repetitions from sitting to standing position during 30 seconds
Measured: 3 months
Chair test 30 seconds
number of repetitions from sitting to standing position during 30 seconds
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start7 Sep 2020
- Primary completion1 May 2023
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Arthritis, DegenerativeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, blinded (patient and outcomes assessor), clinical and radiostereometric trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Haugesund Rheumatism Hospital
- Responsible party
- Sponsor
- Investigators
- Ove Furnes, MD/PhD, Study chair, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525950
- Sponsor's protocol ID
- 2020/68448
- Acronym
- NavioRCT
- Status last verified
- Oct 2024
- First submitted
- 17 Aug 2020
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batailler C, White N, Ranaldi FM, Neyret P, Servien E, Lustig S. Improved implant position and lower revision rate with robotic-assisted unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1232-1240. doi: 10.1007/s00167-018-5081-5. Epub 2018 Jul 31.
PubMed 30066017Petursson G, Fenstad AM, Gothesen O, Dyrhovden GS, Hallan G, Rohrl SM, Aamodt A, Furnes O. Computer-Assisted Compared with Conventional Total Knee Replacement: A Multicenter Parallel-Group Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 1;100(15):1265-1274. doi: 10.2106/JBJS.17.01338.
PubMed 30063588Robinson PG, Clement ND, Hamilton D, Blyth MJG, Haddad FS, Patton JT. A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported. Bone Joint J. 2019 Jul;101-B(7):838-847. doi: 10.1302/0301-620X.101B7.BJJ-2018-1317.R1.
PubMed 31256672Bollars P, Boeckxstaens A, Mievis J, Kalaai S, Schotanus MGM, Janssen D. Preliminary experience with an image-free handheld robot for total knee arthroplasty: 77 cases compared with a matched control group. Eur J Orthop Surg Traumatol. 2020 May;30(4):723-729. doi: 10.1007/s00590-020-02624-3. Epub 2020 Jan 16.
PubMed 31950265Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
PubMed 9699158Roos EM, Roos HP, Ekdahl C, Lohmander LS. Knee injury and Osteoarthritis Outcome Score (KOOS)--validation of a Swedish version. Scand J Med Sci Sports. 1998 Dec;8(6):439-48. doi: 10.1111/j.1600-0838.1998.tb00465.x.
PubMed 9863983Heijbel S, Naili JE, Hedin A, W-Dahl A, Nilsson KG, Hedstrom M. The Forgotten Joint Score-12 in Swedish patients undergoing knee arthroplasty: a validation study with the Knee Injury and Osteoarthritis Outcome Score (KOOS) as comparator. Acta Orthop. 2020 Feb;91(1):88-93. doi: 10.1080/17453674.2019.1689327. Epub 2019 Nov 12.
PubMed 31711349Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013 Apr 24;14:145. doi: 10.1186/1471-2474-14-145.
PubMed 23617377Unver B, Kalkan S, Yuksel E, Kahraman T, Karatosun V. Reliability of the 50-foot walk test and 30-sec chair stand test in total knee arthroplasty. Acta Ortop Bras. 2015 Jul-Aug;23(4):184-7. doi: 10.1590/1413-78522015230401018.
PubMed 26327798Nyberg LA, Hellenius ML, Wandell P, Kowalski J, Sundberg CJ. Maximal step-up height as a simple and relevant health indicator: a study of leg muscle strength and the associations to age, anthropometric variables, aerobic fitness and physical function. Br J Sports Med. 2013 Oct;47(15):992-7. doi: 10.1136/bjsports-2013-092577. Epub 2013 Aug 21.
PubMed 23966416Gothesen O, Espehaug B, Havelin LI, Petursson G, Hallan G, Strom E, Dyrhovden G, Furnes O. Functional outcome and alignment in computer-assisted and conventionally operated total knee replacements: a multicentre parallel-group randomised controlled trial. Bone Joint J. 2014 May;96-B(5):609-18. doi: 10.1302/0301-620X.96B5.32516.
PubMed 24788494Inui H, Taketomi S, Yamagami R, Shirakawa N, Kawaguchi K, Tanaka S. The Relationship between Soft-Tissue Balance and Intraoperative Kinematics of Guided Motion Total Knee Arthroplasty. J Knee Surg. 2019 Jan;32(1):91-96. doi: 10.1055/s-0038-1636545. Epub 2018 Mar 7.
PubMed 29514366Iriuchishima T, Ryu K. Bicruciate Substituting Total Knee Arthroplasty Improves Stair Climbing Ability When Compared with Cruciate-Retain or Posterior Stabilizing Total Knee Arthroplasty. Indian J Orthop. 2019 Sep-Oct;53(5):641-645. doi: 10.4103/ortho.IJOrtho_392_18.
PubMed 31488934Harris AI, Christen B, Malcorps JJ, O'Grady CP, Kopjar B, Sensiba PR, Vandenneucker H, Huang BK, Cates HE, Hur J, Marra DA. Midterm Performance of a Guided-Motion Bicruciate-Stabilized Total Knee System: Results From the International Study of Over 2000 Consecutive Primary Total Knee Arthroplasties. J Arthroplasty. 2019 Jul;34(7S):S201-S208. doi: 10.1016/j.arth.2019.02.011. Epub 2019 Feb 14.
PubMed 31031156Kono K, Inui H, Tomita T, Yamazaki T, Taketomi S, Sugamoto K, Tanaka S. Bicruciate-stabilised total knee arthroplasty provides good functional stability during high-flexion weight-bearing activities. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2096-2103. doi: 10.1007/s00167-019-05375-9. Epub 2019 Apr 10.
PubMed 30972466
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotized Computer Navigation Versus Conventional Technique in Total Knee Replacement. A Randomized, Clinical and Radiostereometric Trial.
- ClinicalTrials.gov ID
- NCT04525950
- Acronym / sponsor ID
- NavioRCT / 2020/68448
- Conditions
- Arthritis, Degenerative, Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, Haugesund Rheumatism Hospital
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 25 Aug 2020 (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.
Navio is a new generation of computer navigation systems allowing intraoperative navigation of the bone cuts relative to both ligaments and skeletal axes, prior to bone removal. An improved accuracy is incorporated by the use of robotics in a burr for bone removal.
This study investigates whether this advanced technology leads to better clinical or radiostereometric results, by comparing one group operated with Navio to another group operated with conventional technique.
Detailed description
Background:
The scientific foundation of total knee replacement (TKR) surgery is incomplete. As a national governor of joint replacements, the Norwegian Arthroplasty Register is obligated to strict regulations, demanding high levels of evidence for implants and instruments utilized by Norwegian surgeons. It is well known that 15-20% of patients with a TKR, are dissatisfied. Nevertheless, only a small proportion of these patients have revision surgery.
In this randomized, clinical trial we will use the Journey II BCS total knee system, with a more native anatomical design, intended to improve the kinematics and functional outcomes by mimicking a native knee, with respect to geometry and its interplay with the ligaments and soft tissue envelope of the knee (i.e. the biomechanics; stability, joint line, off-set, sizing etc.). To achieve an optimal placement of the implant, the surgeon needs to assess a lot of information (experience) during the surgical procedure. To secure this process, and to make sure all aspects are taken into account, with respect to an optimal positioning and ligament balancing, the computer navigation technique may offer valuable input, with further enhancement of the accuracy and precision using precision tools like the Navio from Smith \& Nephew. The Navio system combines robotics and computer navigation, and represents the newest technology within surgical robotics and haptics. This trial is important in the mandatory evaluation process needed, before introducing new technology into orthopaedic surgery, on a larger scale.
Methods:
The surgeons involved have been trained at a wet lab, and on saw bones, before utilizing this tool in a live setting. After the introduction period, the training will continue in a clinical setting until the surgeons have operated at least 20 Navio assisted cases each, followed by a pilot study of 10 patients. All patients will be randomized to either Navio or Conventional technique.
Surgical method: A tourniquet is used. All implant components are cemented (Palacos R+G bone cement is utilized 10 minutes after retrieval from a 4 degrees Celsius refrigerator). Standard para-patellar approach. ACL and PCL are removed. Closing of the wound and capsule in mid-flexion position, Quill for the capsule, Vicryl for the subcutaneous tissue, continuous overlapping mattress with Ethilon suture for the skin. No drainage. Wrapping of the entire limb with elastic dressings for the first 48 hours. Prophylactic antibiotics and anticoagulants are given. Tranexamic acid to reduce bleeding. Postop pain medication: gabapentin, acetaminophen, naproxen, femoral triangle nerve block (repeated next day if needed).
For the conventional group: The rotational alignment is set according to Whiteside's line, and intramedullary rods with 5, 6 or 7 degrees valgus, are selected for the distal femoral cut (dependent on pre-operatively measured angles on long radiographs (hip-knee-ankle). The entry hole of the rod is plugged with bone from the femur to reduce bleeding from the intramedullary canal. The tibial component (metal) is positioned with a 3 degrees posterior slope.
For the Navio group: The cuts are navigated to optimize ligament balance in flexion and extension, and adjusted for mid-flexion instability when needed. A difference of less than 4 mm between lateral and medial gaps is accepted when the laxity is on the lateral side, preferably in flexion. However, if the gap balancing technique suggests a deviation from mechanical alignment of more than 2 degrees of valgus or 4 degrees of varus, the suggestion is overruled by the mechanical alignment (maximum 2 degrees valgus, less than 4 degrees varus).
Sample size calculations: To detect a clinically important difference of 0.17 in the rate of "high responders" and "non-responders" (OMERACT-OARSI criteria) to the Navio, with a standard deviation of 20, power 80% and a 0.05 significance level, a total of 194 patients must be included in the trial (97 patients in each group). The calculations are based on data from a previous study, by Petursson et al, JBJS Am 2018. When 10% eventual drop-outs are taken into account, the total number of patients to be included is 214 (107 patients in each group).
A large number of patients is important, as the expected difference between the groups is small. A small difference may be less clinically relevant, however, may contribute to an overall better outcome for the patients in total. A small improvement of the tools combined with other small improvements may add up to be clinically important in the end. Small trials with no significant differences may disqualify important small improvements, thus stopping any further development in the field. Consequently, large clinical trials will be valuable.
A radiostereometric analysis constitutes a separate study of the trial. A clinically relevant difference of 0.1 mm between the groups will be detected with a standard deviation of 0.1, power 80% and significance level 0.05, if 17 patients are included in each group. Including eventual drop-outs and an expectation of some failures due to the technically challenging investigation method (the RSA), a total of 30 patients will be included in each group. RSA radiographs will be collected within the first week after the operation, at 3 months, 1 year, 2 years and 5 years follow-ups.
The trial is approved by the regional ethics committee and the data inspectorate of Norway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, blinded (patient and outcomes assessor), clinical and radiostereometric trial
| Arm | Type | Receives |
|---|---|---|
| Navio | Experimental | Procedure: NavioUsing the new technology during surgery |
| Conventional | Active comparator | Procedure: ConventionalUsing the conventional surgical instruments |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Degenerative knee in need of a total knee arthroplasty
- Recruited from the hospital's waiting list
- Informed consent
Key exclusion criteria (8 listed)
- Severe systemic illness
- Infections
- Severe neurological dysfunction
- Severe cancer disease
- Severe incompensated heart failure
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 |
|---|---|---|
| NavioNew generation computer navigation with haptics and robotics | Procedure or surgery | Navio |
| ConventionalTotal knee arthroplasty using conventional instruments | Procedure or surgery | Conventional |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) high responders
Time frame: 3 months
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
WOMAC high responders
Time frame: 1 year
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
WOMAC high responders
Time frame: 2 years
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
WOMAC high responders
Time frame: 5 years
Difference in rate (0.00-1.00) of high responders (calculated from KOOS)
Radiostereometric migration
Time frame: 1 year
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
Radiostereometric migration
Time frame: 2 years
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
Radiostereometric migration
Time frame: 5 years
Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)
25 secondary outcomes
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: 3 months
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: 1 year
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: 2 years
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: 5 years
Knee society score (KSS)
Time frame: 3 months
Knee society score (KSS)
Time frame: 1 year
Knee society score (KSS)
Time frame: 2 years
Knee society score (KSS)
Time frame: 5 years
EQ-5D
Time frame: 3 months
EQ-5D
Time frame: 1 year
EQ-5D
Time frame: 2 years
EQ-5D
Time frame: 5 years
Visual analogue scale (VAS)
Time frame: pre-op, 3 months, 1 year, 2 years, 5 years
Forgotten Joint Score (FJS)
Time frame: 3 months
Forgotten Joint Score (FJS)
Time frame: 1 year
Forgotten Joint Score (FJS)
Time frame: 2 years
Forgotten Joint Score (FJS)
Time frame: 5 years
Maximum climb-up test
Time frame: 3 months
Maximum climb-up test
Time frame: 1 year
Anchor questions
Time frame: 2 years
Anchor questions
Time frame: 5 years
Timed 40 meters walking test
Time frame: 3 months
Timed 40 meters walking test
Time frame: 1 year
Chair test 30 seconds
Time frame: 3 months
Chair test 30 seconds
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 30066017Batailler C, White N, Ranaldi FM, Neyret P, Servien E, Lustig S. Improved implant position and lower revision rate with robotic-assisted unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019 Apr;27(4):1232-1240. doi: 10.1007/s00167-018-5081-5. Epub 2018 Jul 31.
- Background: PubMed 30063588Petursson G, Fenstad AM, Gothesen O, Dyrhovden GS, Hallan G, Rohrl SM, Aamodt A, Furnes O. Computer-Assisted Compared with Conventional Total Knee Replacement: A Multicenter Parallel-Group Randomized Controlled Trial. J Bone Joint Surg Am. 2018 Aug 1;100(15):1265-1274. doi: 10.2106/JBJS.17.01338.
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- Individual participant dataSharing planned: No
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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.
Ove Furnes, MD/PhD study chair
University of Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navio and Conventional in people with Arthritis, Degenerative and Osteo Arthritis Knee, run by Haukeland University Hospital at 2 sites in Norway.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) high responders (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04525950, which also lists 18 linked publications.
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 14 Mar 2025.