Knee OsteoarthritisNCT06507046
The personalKNEE Trial
A study testing Total knee replacement in people with Knee Osteoarthritis, run by Helse Møre og Romsdal HF at 1 site in Norway.
Trial summary
Robotic knee surgery makes it possible to adopt different alignment philosophies in total knee arthroplasty. The classical operation where the knee is placed in a neutral manner, the so called mechanical alignment, has been used for decades. The kinematical alignment has recently won popularity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Total knee replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- 25 Aug 2024to 1 May 2035
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence, K-L) grade 2-4 with persistent pain, referred to Kristiansund Hospital for primary TKA
Who cannot join
- serious psychiatric disorders
- dementia
- drug abuse
- patients not able to speak and read Norwegian language making them noncompliant or unable to perform an informed consent
- Patients with ongoing cancer therapy
- Patients with ASA (The American Society of Anesthesiologists physical status class risk stratification system) classification >3
- Patients in the need of walking aid devices
- Patients in need of primary revision arthroplasty or more than 15 degrees of varus or 5 degrees of valgus on preoperative HKA images.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Kristiansund Hospital, Møre and Romsdal Hospital Trust
Kristiansund, Møre and Romsdal, 6508
About this study
Official title: Robotic Assisted Surgery Comparing Personalized Alignment Versus Mechanical Alignment of Total Knee Arthroplasty - A Randomized Controlled Trial
Robotic knee surgery makes it possible to adopt different alignment philosophies in total knee arthroplasty. The classical operation where the knee is placed in a neutral manner, the so called mechanical alignment, has been used for decades. The kinematical alignment has recently won popularity. With this technique the focus is to render the natural knee anatomy even if this means to end up with a varus or valgus position. In this study, the investigators will compare the mechanical alignment and kinematical alignment and test the patients clinically and with a special CT scan to see if this technique gives equal or better longevity of the implants.
Read the detailed description
Mechanical alignment (MA) has for many years been the most used surgical alignment technique in total knee arthroplasty (TKA). This means that regardless of constitutional native anatomy (i.e. valgus or varus), one strives to achieve a neutral coronal knee axis on postoperative x-rays (Hip-Knee-Ankle angle, HKA). To achieve MA, the cuts are made perpendicular to the mechanical axis, and subsequent soft tissue balancing is performed if necessary. However, many patients do not have a neutral knee alignment before they develop osteoarthritis. Several authors therefore advocate the personalized alignment (kinematic, KA or functional alignment, FA), where the aim is to restore the patient's original pre-arthritis anatomy and joint line. This means that tibial component placement in varus or valgus is accepted, despite the possible result of a postoperative non-neutral HKA axis. Studies indicate that good clinical results can be achieved in terms of range of motion (ROM) and patient reported outcome measures (PROMs) with these techniques, but it has not been tested properly in terms of activity measurements, strength testing or migration of implants. There is diversity in the literature regarding whether tibial component with too much deviation from a neutral axis can lead to increased migration and eventually aseptic solution. To date, only a few trials, with diverging results, have assessed migration of the implants implanted with KA or FA. The methods are so far perceived as controversial, despite the widespread use.
KA or FA can be performed by manual conventional surgery; however, the newly introduced robotic assisted surgery probably yields higher accuracy and precision of the cuts during surgery. This makes robotic assisted surgery well suited for personalized surgery. Yet, it is claimed that because of diversity of the different features for planning and executing the surgery, each system should be evaluated separately, and not as a group. The investigators therefore planned this study to assess the efficacy of robotic assisted surgery comparing MA and personalized alignment (PA) techniques.
Aims of the trial
- Evaluate the clinical outcomes of patients who have had TKA with PA and compare it with conventional MA.
- Analyse and compare the in vivo stability over time of TKA operated with PA vs. MA using CT- based radiostereometric analysis (CT-RSA).
- Evaluate the postoperative position of the implants using two different alignment philosophies.
Objective Perform TKAs on patients using ROSA® Knee System (Zimmer Biomet, Warsaw, Indiana USA) robotic assisted surgery and randomize the patients to either PA or MA.
Materials and methods
A multiple blinded randomized controlled parallel superiority trial will be performed, where the patients, study nurse, statistician and physiotherapists are blinded to the surgical method (PA or MA). The study will include 152 patients. The study adheres to the consort statement.
Surgery All surgeons involved in the trial are experienced knee surgeons. The surgeons have received thorough tutoring in the use of the ROSA Knee System and the Persona TKA, and both alignment techniques have now been adopted in our standard treatment of end stage OA. The learning curve of robotic assisted surgery is probably very small, and more related to time spent on the procedure rather than placement of the implants. The placement of the tibial implant will be restricted in the coronal plane to maximum 5 degrees of varus and 2 degrees of valgus. In sagittal plane, the slope will be limited to between 0-10 degrees.
The Persona TKA implant although contemporary, is a well-documented implant with very low migration.
The MA and PA techniques are well known and already used in a widespread fashion all around the world. Several clinics in Norway have also adopted the methods.
Implantation of tantalum markers in bone and polyethylene has been performed for more than 40 years in numerous studies without any known complications.
Known but rare complications to robotic surgery are fractures at the site of insertion of the bone pins, and pin site infections. In elderly or osteoporotic patients, the surgeons will consider using unicortical engagement of the pins. Concerning infections, all the default precautions in the OR will be taken, such as preoperative and postoperative administration of antibiotics, strict sterile procedures etc.
- Conditions
- Knee Osteoarthritis
- Being tested
- Total knee replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacementProcedure or surgery
Mechanical or Personalized alignment
| Study group | Role | What they receive |
|---|---|---|
| Mechanical alignment | Active comparator | Patients are operated with ROSA robot and mechanical alignment Receives: Procedure: Total knee replacement |
| Personalized alignment | Experimental | Patients are operated with ROSA robot and kinematic alignment Receives: Procedure: Total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTPM
Maximum Total Point Motion measured by CT -based RSA in millimeters.
Measured: 2 years
Secondary outcomes (13)
XYZ translation
Translation of implant measured by CT -based RSA in millimeters
Measured: 2 years
XYZ rotation
Rotation of implant measured by CT -based RSA in degrees
Measured: 2 years
Steps per day
ActivePAL accelerator registration of mean steps per day measured 24/7 for a week
Measured: 1 year and 2 years
Walking speed
ActivePAL accelerator registration of mean meter per second measured 24/7 for a week
Measured: 1 and 2 years
Stair climbing
Standardized climbing and descending of stairs up and down. Time in seconds measured up, down and total.
Measured: 1 and 2 years
Maximal voluntary contraction flexion
Isometric contraction at 90 degrees knee flexion measured in Newtons with Tindeq force cell
Measured: 1 and 2 years
Maximal voluntary contraction extension
Isometric contraction at 90 degrees knee extension measured in Newtons with Tindeq force cell
Measured: 1 and 2 years
Maximal voluntary contraction
Isometric contraction at 90 degrees knee flexion measured in Newtons with Tindeq force cell
Measured: 1 and 2 years
Sit to stand test
Maximum number of repetitive transitions from sitting on a chair to standing without the use of hands during 30 seconds
Measured: 1 and 2 years
KOOS score
Knee Injury and Osteoarthritis of 5 dimensions measuring activity of daily living (ADL), Quality of life, Sport and recreation, pain and symptoms. From 0 (bad) to 100 (excellent)
Measured: 1 and 2 years
FJS
Forgotten Joint Score is a 12 item scale assessing the ability to forget the operated joint as artificial during activities of daily living. Ranges from 0 (bad) to 100 (excellent)
Measured: 1 and 2 years
Eq-5D
EuroQol 5 Dimensions is a generic patient reported outcome measure measuring quality of life. The scale ranges from 100 ('the best imaginable health state') to 0 ('the worst imaginable health state' ).
Measured: 1 and 2 years
VAS
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start25 Aug 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, National Taiwan Normal University, University of Oslo, Sectra AB
- Responsible party
- Sponsor
- Investigators
- Frank-David Øhrn, MD, PhD, Study director, Møre og Romsdal Hospital TrustKirsti Sevaldsen, MD, PhD, Study chair, Møre og Romsdal Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507046
- Sponsor's protocol ID
- 738578
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon proper request to the corresponding author data will be shared anonymously.
Publications
Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat award: is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012 Jan;470(1):45-53. doi: 10.1007/s11999-011-1936-5.
PubMed 21656315Lee YS, Howell SM, Won YY, Lee OS, Lee SH, Vahedi H, Teo SH. Kinematic alignment is a possible alternative to mechanical alignment in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3467-3479. doi: 10.1007/s00167-017-4558-y. Epub 2017 Apr 24.
PubMed 28439636Begum FA, Kayani B, Magan AA, Chang JS, Haddad FS. Current concepts in total knee arthroplasty : mechanical, kinematic, anatomical, and functional alignment. Bone Jt Open. 2021 Jun;2(6):397-404. doi: 10.1302/2633-1462.26.BJO-2020-0162.R1.
PubMed 34139884Lustig S, Sappey-Marinier E, Fary C, Servien E, Parratte S, Batailler C. Personalized alignment in total knee arthroplasty: current concepts. SICOT J. 2021;7:19. doi: 10.1051/sicotj/2021021. Epub 2021 Mar 26.
PubMed 33812467Liu B, Feng C, Tu C. Kinematic alignment versus mechanical alignment in primary total knee arthroplasty: an updated meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Apr 4;17(1):201. doi: 10.1186/s13018-022-03097-2.
PubMed 35379289Hasan S, Kaptein BL, Nelissen RGHH, van Hamersveld KT, Toksvig-Larsen S, Marang-van de Mheen PJ. The Influence of Postoperative Coronal Alignment on Tibial Migration After Total Knee Arthroplasty in Preoperative Varus and Valgus Knees: A Secondary Analysis of 10 Randomized Controlled Trials Using Radiostereometric Analysis. J Bone Joint Surg Am. 2021 Dec 15;103(24):2281-2290. doi: 10.2106/JBJS.20.01659.
PubMed 34648477van Hamersveld KT, Marang-van de Mheen PJ, Nelissen RGHH. The Effect of Coronal Alignment on Tibial Component Migration Following Total Knee Arthroplasty: A Cohort Study with Long-Term Radiostereometric Analysis Results. J Bone Joint Surg Am. 2019 Jul 3;101(13):1203-1212. doi: 10.2106/JBJS.18.00691.
PubMed 31274722Laende EK, Richardson CG, Dunbar MJ. A randomized controlled trial of tibial component migration with kinematic alignment using patient-specific instrumentation versus mechanical alignment using computer-assisted surgery in total knee arthroplasty. Bone Joint J. 2019 Aug;101-B(8):929-940. doi: 10.1302/0301-620X.101B8.BJJ-2018-0755.R3.
PubMed 31362561Choi BS, Kim SE, Yang M, Ro DH, Han HS. Functional alignment with robotic-arm assisted total knee arthroplasty demonstrated better patient-reported outcomes than mechanical alignment with manual total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):1072-1080. doi: 10.1007/s00167-022-07227-5. Epub 2022 Nov 15.
PubMed 36378291Vermue H, Batailler C, Monk P, Haddad F, Luyckx T, Lustig S. The evolution of robotic systems for total knee arthroplasty, each system must be assessed for its own value: a systematic review of clinical evidence and meta-analysis. Arch Orthop Trauma Surg. 2023 Jun;143(6):3369-3381. doi: 10.1007/s00402-022-04632-w. Epub 2022 Sep 25.
PubMed 36153769Petersen ET, Rytter S, Koppens D, Dalsgaard J, Hansen TB, Andersen MS, Stilling M. Medial congruent polyethylene design show different tibiofemoral kinematics and enhanced congruency compared to a standard symmetrical cruciate retaining design for total knee arthroplasty-an in vivo randomized controlled study of gait using dynamic radiostereometry. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):933-945. doi: 10.1007/s00167-022-07036-w. Epub 2022 Jul 9.
PubMed 35809105Scott G, Imam MA, Eifert A, Freeman MA, Pinskerova V, Field RE, Skinner J, Banks SA. Can a total knee arthroplasty be both rotationally unconstrained and anteroposteriorly stabilised? A pulsed fluoroscopic investigation. Bone Joint Res. 2016 Mar;5(3):80-6. doi: 10.1302/2046-3758.53.2000621.
PubMed 26965166Mathijssen NMC, Verburg H, London NJ, Landsiedl M, Dominkus M. Patient reported outcomes and implant survivorship after Total knee arthroplasty with the persona knee implant system: two year follow up. BMC Musculoskelet Disord. 2019 Mar 4;20(1):97. doi: 10.1186/s12891-019-2470-y.
PubMed 30832636Christensson A, Tveit M, Kesteris U, Flivik G. Similar migration for medial congruent and cruciate-retaining tibial components in an anatomic TKA system: a randomized controlled trial of 60 patients followed with RSA for 2 years. Acta Orthop. 2022 Jan 3;93:68-74. doi: 10.1080/17453674.2021.1983709.
PubMed 34633885Koster LA, Meinardi JE, Kaptein BL, Van der Linden-Van der Zwaag E, Nelissen RGHH. Two-year RSA migration results of symmetrical and asymmetrical tibial components in total knee arthroplasty: a randomized controlled trial. Bone Joint J. 2021 May;103-B(5):855-863. doi: 10.1302/0301-620X.103B5.BJJ-2020-1575.R2.
PubMed 33934647
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Surgery Comparing Personalized Alignment Versus Mechanical Alignment of Total Knee Arthroplasty - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06507046
- Acronym / sponsor ID
- 738578
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Oslo University Hospital, National Taiwan Normal University, University of Oslo, Sectra AB
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2035 (estimated)
- First posted
- 18 Jul 2024 (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.
Robotic knee surgery makes it possible to adopt different alignment philosophies in total knee arthroplasty. The classical operation where the knee is placed in a neutral manner, the so called mechanical alignment, has been used for decades. The kinematical alignment has recently won popularity. With this technique the focus is to render the natural knee anatomy even if this means to end up with a varus or valgus position. In this study, the investigators will compare the mechanical alignment and kinematical alignment and test the patients clinically and with a special CT scan to see if this technique gives equal or better longevity of the implants.
Detailed description
Mechanical alignment (MA) has for many years been the most used surgical alignment technique in total knee arthroplasty (TKA). This means that regardless of constitutional native anatomy (i.e. valgus or varus), one strives to achieve a neutral coronal knee axis on postoperative x-rays (Hip-Knee-Ankle angle, HKA). To achieve MA, the cuts are made perpendicular to the mechanical axis, and subsequent soft tissue balancing is performed if necessary. However, many patients do not have a neutral knee alignment before they develop osteoarthritis. Several authors therefore advocate the personalized alignment (kinematic, KA or functional alignment, FA), where the aim is to restore the patient's original pre-arthritis anatomy and joint line. This means that tibial component placement in varus or valgus is accepted, despite the possible result of a postoperative non-neutral HKA axis. Studies indicate that good clinical results can be achieved in terms of range of motion (ROM) and patient reported outcome measures (PROMs) with these techniques, but it has not been tested properly in terms of activity measurements, strength testing or migration of implants. There is diversity in the literature regarding whether tibial component with too much deviation from a neutral axis can lead to increased migration and eventually aseptic solution. To date, only a few trials, with diverging results, have assessed migration of the implants implanted with KA or FA. The methods are so far perceived as controversial, despite the widespread use.
KA or FA can be performed by manual conventional surgery; however, the newly introduced robotic assisted surgery probably yields higher accuracy and precision of the cuts during surgery. This makes robotic assisted surgery well suited for personalized surgery. Yet, it is claimed that because of diversity of the different features for planning and executing the surgery, each system should be evaluated separately, and not as a group. The investigators therefore planned this study to assess the efficacy of robotic assisted surgery comparing MA and personalized alignment (PA) techniques.
Aims of the trial
- Evaluate the clinical outcomes of patients who have had TKA with PA and compare it with conventional MA.
- Analyse and compare the in vivo stability over time of TKA operated with PA vs. MA using CT- based radiostereometric analysis (CT-RSA).
- Evaluate the postoperative position of the implants using two different alignment philosophies.
Objective Perform TKAs on patients using ROSA® Knee System (Zimmer Biomet, Warsaw, Indiana USA) robotic assisted surgery and randomize the patients to either PA or MA.
Materials and methods
A multiple blinded randomized controlled parallel superiority trial will be performed, where the patients, study nurse, statistician and physiotherapists are blinded to the surgical method (PA or MA). The study will include 152 patients. The study adheres to the consort statement.
Surgery All surgeons involved in the trial are experienced knee surgeons. The surgeons have received thorough tutoring in the use of the ROSA Knee System and the Persona TKA, and both alignment techniques have now been adopted in our standard treatment of end stage OA. The learning curve of robotic assisted surgery is probably very small, and more related to time spent on the procedure rather than placement of the implants. The placement of the tibial implant will be restricted in the coronal plane to maximum 5 degrees of varus and 2 degrees of valgus. In sagittal plane, the slope will be limited to between 0-10 degrees.
The Persona TKA implant although contemporary, is a well-documented implant with very low migration.
The MA and PA techniques are well known and already used in a widespread fashion all around the world. Several clinics in Norway have also adopted the methods.
Implantation of tantalum markers in bone and polyethylene has been performed for more than 40 years in numerous studies without any known complications.
Known but rare complications to robotic surgery are fractures at the site of insertion of the bone pins, and pin site infections. In elderly or osteoporotic patients, the surgeons will consider using unicortical engagement of the pins. Concerning infections, all the default precautions in the OR will be taken, such as preoperative and postoperative administration of antibiotics, strict sterile procedures etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mechanical alignment | Active comparator | Procedure: Total knee replacementPatients are operated with ROSA robot and mechanical alignment |
| Personalized alignment | Experimental | Procedure: Total knee replacementPatients are operated with ROSA robot and kinematic alignment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence, K-L) grade 2-4 with persistent pain, referred to Kristiansund Hospital for primary TKA
Key exclusion criteria (8 listed)
- serious psychiatric disorders
- dementia
- drug abuse
- patients not able to speak and read Norwegian language making them noncompliant or unable to perform an informed consent
- Patients with ongoing cancer therapy
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 |
|---|---|---|
| Total knee replacementMechanical or Personalized alignment | Procedure or surgery | Mechanical alignment, Personalized alignment |
Primary outcome
MTPM
Time frame: 2 years
Maximum Total Point Motion measured by CT -based RSA in millimeters.
13 secondary outcomes
XYZ translation
Time frame: 2 years
XYZ rotation
Time frame: 2 years
Steps per day
Time frame: 1 year and 2 years
Walking speed
Time frame: 1 and 2 years
Stair climbing
Time frame: 1 and 2 years
Maximal voluntary contraction flexion
Time frame: 1 and 2 years
Maximal voluntary contraction extension
Time frame: 1 and 2 years
Maximal voluntary contraction
Time frame: 1 and 2 years
Sit to stand test
Time frame: 1 and 2 years
KOOS score
Time frame: 1 and 2 years
FJS
Time frame: 1 and 2 years
Eq-5D
Time frame: 1 and 2 years
VAS
Time frame: 1 and 2 years
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 5 Oct 2026.
- Background: PubMed 21656315Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat award: is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012 Jan;470(1):45-53. doi: 10.1007/s11999-011-1936-5.
- Background: PubMed 28439636Lee YS, Howell SM, Won YY, Lee OS, Lee SH, Vahedi H, Teo SH. Kinematic alignment is a possible alternative to mechanical alignment in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Nov;25(11):3467-3479. doi: 10.1007/s00167-017-4558-y. Epub 2017 Apr 24.
- Background: PubMed 34139884Begum FA, Kayani B, Magan AA, Chang JS, Haddad FS. Current concepts in total knee arthroplasty : mechanical, kinematic, anatomical, and functional alignment. Bone Jt Open. 2021 Jun;2(6):397-404. doi: 10.1302/2633-1462.26.BJO-2020-0162.R1.
- Background: PubMed 33812467Lustig S, Sappey-Marinier E, Fary C, Servien E, Parratte S, Batailler C. Personalized alignment in total knee arthroplasty: current concepts. SICOT J. 2021;7:19. doi: 10.1051/sicotj/2021021. Epub 2021 Mar 26.
- Background: PubMed 35379289Liu B, Feng C, Tu C. Kinematic alignment versus mechanical alignment in primary total knee arthroplasty: an updated meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Apr 4;17(1):201. doi: 10.1186/s13018-022-03097-2.
- Background: PubMed 34648477Hasan S, Kaptein BL, Nelissen RGHH, van Hamersveld KT, Toksvig-Larsen S, Marang-van de Mheen PJ. The Influence of Postoperative Coronal Alignment on Tibial Migration After Total Knee Arthroplasty in Preoperative Varus and Valgus Knees: A Secondary Analysis of 10 Randomized Controlled Trials Using Radiostereometric Analysis. J Bone Joint Surg Am. 2021 Dec 15;103(24):2281-2290. doi: 10.2106/JBJS.20.01659.
- Background: PubMed 31274722van Hamersveld KT, Marang-van de Mheen PJ, Nelissen RGHH. The Effect of Coronal Alignment on Tibial Component Migration Following Total Knee Arthroplasty: A Cohort Study with Long-Term Radiostereometric Analysis Results. J Bone Joint Surg Am. 2019 Jul 3;101(13):1203-1212. doi: 10.2106/JBJS.18.00691.
- Background: PubMed 31362561Laende EK, Richardson CG, Dunbar MJ. A randomized controlled trial of tibial component migration with kinematic alignment using patient-specific instrumentation versus mechanical alignment using computer-assisted surgery in total knee arthroplasty. Bone Joint J. 2019 Aug;101-B(8):929-940. doi: 10.1302/0301-620X.101B8.BJJ-2018-0755.R3.
- Background: PubMed 36378291Choi BS, Kim SE, Yang M, Ro DH, Han HS. Functional alignment with robotic-arm assisted total knee arthroplasty demonstrated better patient-reported outcomes than mechanical alignment with manual total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):1072-1080. doi: 10.1007/s00167-022-07227-5. Epub 2022 Nov 15.
- Background: PubMed 36153769Vermue H, Batailler C, Monk P, Haddad F, Luyckx T, Lustig S. The evolution of robotic systems for total knee arthroplasty, each system must be assessed for its own value: a systematic review of clinical evidence and meta-analysis. Arch Orthop Trauma Surg. 2023 Jun;143(6):3369-3381. doi: 10.1007/s00402-022-04632-w. Epub 2022 Sep 25.
- Background: PubMed 35809105Petersen ET, Rytter S, Koppens D, Dalsgaard J, Hansen TB, Andersen MS, Stilling M. Medial congruent polyethylene design show different tibiofemoral kinematics and enhanced congruency compared to a standard symmetrical cruciate retaining design for total knee arthroplasty-an in vivo randomized controlled study of gait using dynamic radiostereometry. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):933-945. doi: 10.1007/s00167-022-07036-w. Epub 2022 Jul 9.
- Background: PubMed 26965166Scott G, Imam MA, Eifert A, Freeman MA, Pinskerova V, Field RE, Skinner J, Banks SA. Can a total knee arthroplasty be both rotationally unconstrained and anteroposteriorly stabilised? A pulsed fluoroscopic investigation. Bone Joint Res. 2016 Mar;5(3):80-6. doi: 10.1302/2046-3758.53.2000621.
- Consort StatementLink provided by the sponsor.
- ASA classification systemLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon proper request to the corresponding author data will be shared anonymously.
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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.
Frank-David Øhrn, MD, PhD study director
Møre og Romsdal Hospital Trust
Kirsti Sevaldsen, MD, PhD study chair
Møre og Romsdal Hospital Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement in people with Knee Osteoarthritis, run by Helse Møre og Romsdal HF at 1 site 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 1 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
MTPM (time frame: 2 years). 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 NCT06507046, which also lists 39 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 5 Oct 2026.