Robotized Navigation Compared to Conventional Technique in Total Knee Replacement

Osteo Arthritis Knee Clinical Trial

— NavioRCT  

Official title:

Robotized Computer Navigation Versus Conventional Technique in Total Knee Replacement. A Randomized, Clinical and Radiostereometric Trial.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04525950
• Other study ID #: 2020/68448
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: December 31, 2031

Study information

• Verified date: March 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 214
• Est. completion date: December 31, 2031
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• Degenerative knee in need of a total knee arthroplasty

• Recruited from the hospital's waiting list

• Informed consent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Degenerative
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Navio
New generation computer navigation with haptics and robotics
• Conventional
Total knee arthroplasty using conventional instruments

Locations

Country	Name	City	State
Norway	Haukeland university hospital	Bergen
Norway	Haugesund sanitetsforenings revmatismesykehus	Haugesund

Sponsors (3)

Lead Sponsor	Collaborator
Haukeland University Hospital	Haugesund Rheumatism Hospital, University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (18)

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. — View Citation

Bollars 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. — View Citation

Di Benedetto P, Buttironi MM, Magnanelli S, Cainero V, Causero A. Comparison between standard technique and image-free robotic technique in medial unicompartmental knee arthroplasty. Preliminary data. Acta Biomed. 2019 Dec 5;90(12-S):104-108. doi: 10.23750/abm.v90i12-S.8994. — View Citation

Gothesen 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. — View Citation

Harris 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. — View Citation

Heijbel 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. — View Citation

Inui 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. — View Citation

Iriuchishima 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. — View Citation

Ko 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. — View Citation

Kono 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. — View Citation

Nyberg 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. — View Citation

Petursson 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. — View Citation

Petursson G, Fenstad AM, Gothesen O, Haugan K, Dyrhovden GS, Hallan G, Rohrl SM, Aamodt A, Nilsson KG, Furnes O. Similar migration in computer-assisted and conventional total knee arthroplasty. Acta Orthop. 2017 Apr;88(2):166-172. doi: 10.1080/17453674.2016.1267835. Epub 2016 Dec 20. — View Citation

Robinson 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. — View Citation

Roos 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. — View Citation

Roos 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. — View Citation

Unver B, Kahraman T, Kalkan S, Yuksel E, Karatosun V. Reliability of the six-minute walk test after total hip arthroplasty. Hip Int. 2013 Nov-Dec;23(6):541-5. doi: 10.5301/hipint.5000073. Epub 2013 Aug 6. — View Citation

Unver 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Position of the implant on radiographs, coronal and sagittal plane	Femoral/tibial components: varus/valgus and flexion/extension, off-set of the femoral component	3 months
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) high responders	Difference in rate (0.00-1.00) of high responders (calculated from KOOS)	3 months
Primary	WOMAC high responders	Difference in rate (0.00-1.00) of high responders (calculated from KOOS)	1 year
Primary	WOMAC high responders	Difference in rate (0.00-1.00) of high responders (calculated from KOOS)	2 years
Primary	WOMAC high responders	Difference in rate (0.00-1.00) of high responders (calculated from KOOS)	5 years
Primary	Radiostereometric migration	Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)	1 year
Primary	Radiostereometric migration	Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)	2 years
Primary	Radiostereometric migration	Maximum total point of motion MTPM (millimeters), (includes only first 60 patients)	5 years
Secondary	Knee injury and osteoarthritis outcome score (KOOS)	Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0(worse)-100(better))	3 months
Secondary	Knee injury and osteoarthritis outcome score (KOOS)	Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)	1 year
Secondary	Knee injury and osteoarthritis outcome score (KOOS)	Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)	2 years
Secondary	Knee injury and osteoarthritis outcome score (KOOS)	Symptoms, Stiffness, Pain, Activity of daily living, Sports, Quality of life subscores (0-100)	5 years
Secondary	Knee society score (KSS)	Knee society score, knee score (0(worse)-100(better)) and function score (0(worse)-100(better))	3 months
Secondary	Knee society score (KSS)	Knee society score, knee score (0-100) and function score (0-100)	1 year
Secondary	Knee society score (KSS)	Knee society score, knee score (0-100) and function score (0-100)	2 years
Secondary	Knee society score (KSS)	Knee society score, knee score (0-100) and function score (0-100)	5 years
Secondary	EQ-5D	Euroqol, quality of life (0(worse)-100(better))	3 months
Secondary	EQ-5D	Euroqol, quality of life (0-100)	1 year
Secondary	EQ-5D	Euroqol, quality of life (0-100)	2 years
Secondary	EQ-5D	Euroqol, quality of life (0-100)	5 years
Secondary	Visual analogue scale (VAS)	Visual Analogue Scale pain (0(worse)-100(better))	pre-op, 3 months, 1 year, 2 years, 5 years
Secondary	Forgotten Joint Score (FJS)	Forgotten Joint Score (0(worse)-100(better))	3 months
Secondary	Forgotten Joint Score (FJS)	Forgotten Joint Score (0-100)	1 year
Secondary	Forgotten Joint Score (FJS)	Forgotten Joint Score (0-100)	2 years
Secondary	Forgotten Joint Score (FJS)	Forgotten Joint Score (0-100)	5 years
Secondary	Maximum climb-up test	Height (cm) of one stair climbed with affected/operated limb (no pulling by hands)	3 months
Secondary	Maximum climb-up test	Height (cm) of one stair climbed with affected/operated limb (no pulling by hands)	1 year
Secondary	Anchor questions	Are you satisfied with the outcome? Would you do it again?	2 years
Secondary	Anchor questions	Are you satisfied with the outcome? Would you do it again?	5 years
Secondary	Timed 40 meters walking test	Time spent walking 40 meters	3 months
Secondary	Timed 40 meters walking test	Time spent (in seconds) walking 40 meters	1 year
Secondary	Chair test 30 seconds	number of repetitions from sitting to standing position during 30 seconds	3 months
Secondary	Chair test 30 seconds	number of repetitions from sitting to standing position during 30 seconds	1 year