ArthritisNCT06709703
Kinematic Alignment in Total Knee Arthroplasty - a Double-blind Randomised Controlled Trial Between Robotic and Caliper-based Techniques
A study testing Kinematic aligned total knee replacement in people with Arthritis and Arthritis (Knee), run by Université de Sherbrooke.
Trial summary
Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Arthritis (Knee), Osteoarthritis
- What is being tested?
- Kinematic aligned total knee replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 or above
- Patient being consented for a primary total knee arthroplasty (TKA)
- The primary TKA is planned to be done with kinematic alignment
- All pre-operative alignments are included
Who cannot join
- Revision TKA (including revision of unicompartimental knee arthroplasty into total knee arthroplasty with primary components). TKA being done in the setting of previous femur or tibia fracture or osteotomy are however included.
- No available adequate pre-operative imaging
- Patient who does want to be randomized of the two groups
- At the discretion of the surgeon, if the patient's pathology or particular anatomy precludes the use of kinematic alignment technique, robotic surgery, or traditional instrument TKA.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: L'Alignement cinématique Dans Les prothèses de Totales de Genou : un Essai randomisé contrôlé à Double Insu Comparant la Robotique Aux Instruments Traditionnels
Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has shown promise in improving the satisfaction after knee replacement surgery. It is not known if using a robotic arm to assist in surgery is better than the traditional method when trying to recreate kinematic alignment.
The goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main questions the study tries to answer are:
Read more
- Do the radiographs of kinematic knee replacement surgeries done with robotic assistance show better alignment than radiographs of kinematic knee replacements done with the traditional method?
- Does robotic assisted kinematic knee replacement give better function to patients than traditional knee replacement done with kinematic alignment?
- Does robotic assisted kinematic knee replacement decrease pain, improve knee movement and improve knee stability better than traditional knee replacement done with kinematic alignment?
- Are there more complications with robotic assisted kinematic knee replacement in comparison to traditional kinematic knee replacement?
- How long long does it take a surgeon to become good a performing a kinematic knee replacement using robotic assistance? Researchers will compare knee replacements done using a robotic to make the bone cuts, and compare it to the usual method using guides and manual instruments. All the knee replacements will be done using the kinematic alignment and with the same type of knee replacement prothesis.
Participants will:
- Have a knee replacement done with the kinematic alignment technique by an experienced surgeon, with or without robotic assistance during the surgery.
- Visit the clinic before surgery, six weeks after surgery, three months, six months, twelve months and twenty-four months after the surgery.
- Fill questionnaire, have their knee examined and have radiographs of their knee done at each visit.
- Conditions
- Arthritis, Arthritis (Knee), Osteoarthritis, Osteoarthritis Knee Pain, OA, OA Knee
- Being tested
- Kinematic aligned total knee replacement
- Keywords
- osteoarthritis, arthritis, knee osteoarthritis, knee OA, knee arthritis, total knee replacement, robotic, kinematic alignment, patient-specific surgery
- Medical subject headings
- Arthritis, Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematic aligned total knee replacementProcedure or surgery
Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.
| Study group | Role | What they receive |
|---|---|---|
| Kinematic knee replacement with traditional instruments | Active comparator | Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides Receives: Procedure: Kinematic aligned total knee replacement |
| Robotic-assisted kinematic knee replacement | Experimental | Patients will undergo kinematic aligned knee replacement done using robotic assistance Receives: Procedure: Kinematic aligned total knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic alignment of the knee
Long leg anteroposterior views of both legs and lateral knee radiographs will be used to measure knee alignment and position of the knee replacement hardware. The angles measured and analyzed will be:
- The hip-knee-ankle (HKA) angle
- Medial proximal tibia mechanical angle (MPTAm)
- Lateral distal femur mechanical angle (LDTAm)
- Distal femur flexion angle (DFFA)
- Posterior tibial slope (PTS) Radiographic measurements will be made by a trained observer and a fellowship-train arthroplasty surgeon.
Measured: Pre-operative alignement and 6 months post-operative alignement.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient questionnaire (42 questions) evaluating knee pain, symptoms, function, recreational activities and knee-related quality of life. The questionnaire is score over 100 points, with a higher score meaning better knee function.
Measured: Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative
Forgotten joint score
A 12-questions form asking patients if they forget about their joint during activities of daily living.
Measured: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op
Joint perception question
A single item question asking participants how they perceive their operated knee, from "like a native or natural joint" to "like a nonfunctional joint".
Measured: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative
Secondary outcomes (4)
Pain visual analog scale
Pain rated on a 10 cm visual analog scale from "no pain" to "worst pain imaginable"
Measured: Pre-op, 6 weeks, 6, 12, 24 months
Subjective Assessment Numeric Evaluation Scale (SANE)
Single question evaluation scale asking the patient to rate their knee function from 0 (no function) to 100 (completely normal function)
Measured: Pre-op, 6 weeks, 6, 12, 24 months
Knee range of motion
Maximum passive flexion and extension measured with goniometer
Measured: Pre, 6 weeks, 6 and 12 months post-op
Knee stability
Anterior drawer, posterior drawer, valgus stress, varus stress. Instability rated for each test 1 to 3 by treating surgeon.
Measured: Pre-op, 6 weeks, 6 and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study startFeb 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies 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
- Double-blind randomized controlled-trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Charles Lemoyne
- Responsible party
- Principal investigator, Samuel Larrivée, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709703
- Sponsor's protocol ID
- 2025-958
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Anonymous individual patient data will be shared only with a direct request to the study principal investigator.
Publications
Zhang J, Ndou WS, Ng N, Gaston P, Simpson PM, Macpherson GJ, Patton JT, Clement ND. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2677-2695. doi: 10.1007/s00167-021-06464-4. Epub 2021 Feb 6.
PubMed 33547914Agarwal N, To K, McDonnell S, Khan W. Clinical and Radiological Outcomes in Robotic-Assisted Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2020 Nov;35(11):3393-3409.e2. doi: 10.1016/j.arth.2020.03.005. Epub 2020 Mar 11.
PubMed 32234326Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17.
PubMed 36403396Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.
PubMed 24986944Turan K, Camurcu Y, Kezer M, Uysal Y, Kizilay YO, Ucpunar H, Temiz A. A comparison of robotic-assisted and manual techniques in restricted kinematically aligned total knee arthroplasty: coronal alignment improvement with no significant clinical differences. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4673-4679. doi: 10.1007/s00167-023-07426-8. Epub 2023 May 10.
PubMed 37165209
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L'Alignement cinématique Dans Les prothèses de Totales de Genou : un Essai randomisé contrôlé à Double Insu Comparant la Robotique Aux Instruments Traditionnels
- ClinicalTrials.gov ID
- NCT06709703
- Acronym / sponsor ID
- 2025-958
- Conditions
- Arthritis, Arthritis (Knee), Osteoarthritis, Osteoarthritis Knee Pain, OA, OA Knee
- Keywords
- osteoarthritis, arthritis, knee osteoarthritis, knee OA, knee arthritis, total knee replacement, robotic, kinematic alignment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Hopital Charles Lemoyne
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 Nov 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.
Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has shown promise in improving the satisfaction after knee replacement surgery. It is not known if using a robotic arm to assist in surgery is better than the traditional method when trying to recreate kinematic alignment.
The goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main questions the study tries to answer are:
- Do the radiographs of kinematic knee replacement surgeries done with robotic assistance show better alignment than radiographs of kinematic knee replacements done with the traditional method?
- Does robotic assisted kinematic knee replacement give better function to patients than traditional knee replacement done with kinematic alignment?
- Does robotic assisted kinematic knee replacement decrease pain, improve knee movement and improve knee stability better than traditional knee replacement done with kinematic alignment?
- Are there more complications with robotic assisted kinematic knee replacement in comparison to traditional kinematic knee replacement?
- How long long does it take a surgeon to become good a performing a kinematic knee replacement using robotic assistance? Researchers will compare knee replacements done using a robotic to make the bone cuts, and compare it to the usual method using guides and manual instruments. All the knee replacements will be done using the kinematic alignment and with the same type of knee replacement prothesis.
Participants will:
- Have a knee replacement done with the kinematic alignment technique by an experienced surgeon, with or without robotic assistance during the surgery.
- Visit the clinic before surgery, six weeks after surgery, three months, six months, twelve months and twenty-four months after the surgery.
- Fill questionnaire, have their knee examined and have radiographs of their knee done at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized controlled-trial
| Arm | Type | Receives |
|---|---|---|
| Kinematic knee replacement with traditional instruments | Active comparator | Procedure: Kinematic aligned total knee replacementPatients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides |
| Robotic-assisted kinematic knee replacement | Experimental | Procedure: Kinematic aligned total knee replacementPatients will undergo kinematic aligned knee replacement done using robotic assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 or above
- Patient being consented for a primary total knee arthroplasty (TKA)
- The primary TKA is planned to be done with kinematic alignment
- All pre-operative alignments are included
Key exclusion criteria (4 listed)
- Revision TKA (including revision of unicompartimental knee arthroplasty into total knee arthroplasty with primary components). TKA being done in the setting of previous femur or tibia fracture or osteotomy are however included.
- No available adequate pre-operative imaging
- Patient who does want to be randomized of the two groups
- At the discretion of the surgeon, if the patient's pathology or particular anatomy precludes the use of kinematic alignment technique, robotic surgery, or traditional instrument TKA.
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 |
|---|---|---|
| Kinematic aligned total knee replacementReplacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance. | Procedure or surgery | Kinematic knee replacement with traditional instruments, Robotic-assisted kinematic knee replacement |
Primary outcome
Radiographic alignment of the knee
Time frame: Pre-operative alignement and 6 months post-operative alignement.
Long leg anteroposterior views of both legs and lateral knee radiographs will be used to measure knee alignment and position of the knee replacement hardware. The angles measured and analyzed will be: * The hip-knee-ankle (HKA) angle * Medial proximal tibia mechanical angle (MPTAm) * Lateral distal femur mechanical angle (LDTAm) * Distal femur flexion angle (DFFA) * Posterior tibial slope (PTS) Radiographic measurements will be made by a trained observer and a fellowship-train arthroplasty surgeon.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative
Patient questionnaire (42 questions) evaluating knee pain, symptoms, function, recreational activities and knee-related quality of life. The questionnaire is score over 100 points, with a higher score meaning better knee function.
Forgotten joint score
Time frame: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op
A 12-questions form asking patients if they forget about their joint during activities of daily living.
Joint perception question
Time frame: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative
A single item question asking participants how they perceive their operated knee, from "like a native or natural joint" to "like a nonfunctional joint".
4 secondary outcomes
Pain visual analog scale
Time frame: Pre-op, 6 weeks, 6, 12, 24 months
Subjective Assessment Numeric Evaluation Scale (SANE)
Time frame: Pre-op, 6 weeks, 6, 12, 24 months
Knee range of motion
Time frame: Pre, 6 weeks, 6 and 12 months post-op
Knee stability
Time frame: Pre-op, 6 weeks, 6 and 12 months post-op
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 29 Nov 2024.
- Background: PubMed 33547914Zhang J, Ndou WS, Ng N, Gaston P, Simpson PM, Macpherson GJ, Patton JT, Clement ND. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2677-2695. doi: 10.1007/s00167-021-06464-4. Epub 2021 Feb 6.
- Background: PubMed 32234326Agarwal N, To K, McDonnell S, Khan W. Clinical and Radiological Outcomes in Robotic-Assisted Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2020 Nov;35(11):3393-3409.e2. doi: 10.1016/j.arth.2020.03.005. Epub 2020 Mar 11.
- Background: PubMed 36403396Van Essen J, Stevens J, Dowsey MM, Choong PF, Babazadeh S. Kinematic alignment results in clinically similar outcomes to mechanical alignment: Systematic review and meta-analysis. Knee. 2023 Jan;40:24-41. doi: 10.1016/j.knee.2022.11.001. Epub 2022 Nov 17.
- Background: PubMed 24986944Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.
- Background: PubMed 37165209Turan K, Camurcu Y, Kezer M, Uysal Y, Kizilay YO, Ucpunar H, Temiz A. A comparison of robotic-assisted and manual techniques in restricted kinematically aligned total knee arthroplasty: coronal alignment improvement with no significant clinical differences. Knee Surg Sports Traumatol Arthrosc. 2023 Nov;31(11):4673-4679. doi: 10.1007/s00167-023-07426-8. Epub 2023 May 10.
- Individual participant dataSharing planned: No. Anonymous individual patient data will be shared only with a direct request to the study principal investigator.
Related trials for Arthritis
Not yet recruitingPhase 2
Platform Study of Targeted Therapies for Adults With Moderately to Severely Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
RecruitingPhase 3
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Gout
RecruitingObservational study
Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus
SLE - Systemic Lupus Erythematosus
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.
Questions about this trial
What is this clinical trial studying?
A study testing Kinematic aligned total knee replacement in people with Arthritis and Arthritis (Knee), run by Université de Sherbrooke.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Samuel Larrivée, MD, MSc, FRCSC (450-466-4333 ext. 2, samuel.larrivee@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic alignment of the knee (time frame: Pre-operative alignement and 6 months post-operative alignement.). The study lists 4 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 NCT06709703, which also lists 5 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 29 Nov 2024.