Osteo Arthritis KneeNCT04092153
Mako Functionally Aligned Total Knee Arthroplasty vs Mako Mechanically Aligned Total Knee Arthroplasty
A study testing Total knee arthroplasy in people with Osteo Arthritis Knee and Osteoarthritis, run by University College, London at 1 site in United Kingdom.
Trial summary
This study evaluates outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty [MA TKA] versus robotic-arm assisted functionally aligned total knee arthroplasty [FA TKA]. Half the study will receive MA TKA and half will receive FA TKA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee, Osteoarthritis, Surgery
- What is being tested?
- Total knee arthroplasy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Dec 2018to 6 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient has symptomatic knee osteoarthritis requiring primary TKA
- Patient and surgeon are in agreement that TKA is the most appropriate treatment
- Patient is fit for surgical intervention following review by surgeon and anaesthetist
- Patient is between 18-80 years of age at time of surgery
- Gender: male and female
- Patient must be capable of giving informed consent and agree to comply with the postoperative review program
- Patient must be a permanent resident in an area accessible to the study site
- Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken
Who cannot join
- Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis
- Patient has bone loss that requires augmentation
- Patient is not medically fit for surgical intervention
- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA
- Patient is immobile or has another neurological condition affecting musculoskeletal function
- Patient is less than 18 years of age or greater than 80 years of age
Show all 10Show fewer
- Patient is already enrolled on another concurrent clinical trial
- Patient is unable or unwilling to sign the informed consent form specific to this study
- Patient is unable to attend the follow-up programme
- Patient is non-resident in local area or expected to leave the catchment area postoperatively
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital NHS Foundation Trust
London, NW1 2PG
About this study
Official title: A Prospective Randomised Control Trial Comparing Mako Robotic-arm Assisted Functionally Aligned Total Knee Arthroplasty Versus Mako Robotic-arm Assisted Mechanically Aligned Total Knee Arthroplasty
This study evaluates outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty [MA TKA] versus robotic-arm assisted functionally aligned total knee arthroplasty [FA TKA]. Half the study will receive MA TKA and half will receive FA TKA.
Read the detailed description
Total knee arthroplasty [TKA] is an estabilshed treatment for symptomatic end-stage knee osteoarthritis, but there is a higher disatisfaction rate when compared to total hip arthroplasty. The exact aetiology of this is not clear but recent studies have shown one possible reason to be conventional TKA with mechanical alignment [MA] may force the knee into an unnatural position. This may lead to altered knee anatomy and kinematics that may compromise patient satisfaction.
Total knee arthroplasty using functional alignment [FA] aims to restore the patient's prearthritic knee anatomy and native joint kinematics. Early clinical and functional outcome studies have reported promising outcomes in TKA with FA but results of longer term studies have not yet been published.
There are very few prospective studies exploring clinical and radiological outcomes in MA versus FA for TKA. It is possible to improve on previous studies by recording a more comprehensive range of clinical and functional outcome measures, blinding patients and observers recording outcomes of interest, and using longer follow-up times.
Robotic-arm assistance can be used to improve the accuracy of implant positioning. Clinical and functional outcomes should also be correlated to longer-term outcomes to better establish the "safe zone" for functional alignment. The findings of this study will enable an improved understanding of the clinical and functional benefits of FA compared to MA. These outcomes will improve our understanding of the optimal TKA alignment with possible improved outcomes; improved cost-effectiveness by reduced revisions and better patient satisfaction and function; and improved long-term implant survival.
100 patients will be enrolled in a 1:1 ratio between the two treatment groups. Trial patient will be allocated to either the MA TKA ['Control group'] or to the FA TKA ['Investigation group']. Outcomes will be recorded at specific milestones.
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Surgery
- Being tested
- Total knee arthroplasy
- Keywords
- total knee arthroplasty, total knee replacement, functional alignment, kinematic alignment, robotic surgery, mako robot, makoplasty, patient outcomes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasyDevice
Surgical implantation of prosthetic knee using robotic-arm assist
| Study group | Role | What they receive |
|---|---|---|
| Mechanically aligned | Active comparator | Neutral limb alignment irrespective of the patient's native knee anatomy and joint mechanics Receives: Device: Total knee arthroplasy |
| Functionally aligned | Experimental | Restore the patient's own pre-arthritic knee anatomy Receives: Device: Total knee arthroplasy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and Mcmaster Universities Arthritis Index (WOMAC)
Patient recorded outcome questionnaire evaluating pain, stiffness and disability in affected joint
Measured: 2 years post-intervention
Secondary outcomes (15)
Lower limb alignment
Assessed using Computerised Tomography (CT) scanogram. Measurements of the hip-knee-angle (HKA), medial proximal tibial angle (MPTA), lateral distal femoral angle (LDFA), femoral flexion angle, and posterior tibial slope will be recorded preoperatively and postoperatively
Measured: pre op and 6 weeks post op
Operating time
Operating time [minutes]
Measured: interoperative
Time to discharge
Time to discharge from admission until documented discharge from hospital (hours)
Measured: Documented when participant leaves hospital, an average of 72 -96 hours
Forgotten Joint Score (FJS)
Patient recorded outcome measure via questionnaire. Score cumulative with -100 being best score and 0 being worst score
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Oxford Knee Score (OKS)
Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Short form health survey of 12 items (SF-12),
Patient recorded outcome measure. Questions concerning attitudes to physical and mental heath with 12 questions combined to give overall norm-based values; higher score better, lower score worse.
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Knee injury and osteoarthritis outcome score (KOOS)
Patient recorded outcome measure via questionnaire. 6 separate domains including pain, stiffness, quality of life, symptoms, and function; each domain creates percentage with overall cumulative percentage achieved; best score 100%
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
University of California at Los Angeles knee (UCLA)
Patient recorded outcome measure via questionnaire. Patient records current level of activity; 10 best possible score, 0 worst possible score
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
Patient recorded outcome measure with 5 domains; score -1 to 1, with 1 being best score
Measured: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Use of mobility aids
description of any mobility aids used to assist with ambulation; can describe wheelchair, walker, crutches, sticks or no need for any mobility aid
Measured: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Mobilisation distance
Mobilisation distance (metres)
Measured: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Range of movement
Range of movement (degrees) in knee joint
Measured: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years
radiosteriometric analysis (RSA)
Femoral and tibial implant early migration as assessed using RSA
Measured: postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years
Gait analysis
Walking on an instrumented treadmill with force plates
Measured: performed postoperatively at 6 months and 1 year postoperatively
Complications
Complications relating to surgery
Measured: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year 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 posted17 Sep 2019
- Study start28 Dec 2018
- Primary completion6 Feb 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Fares S Haddad, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092153
- Sponsor's protocol ID
- 17/0721
- Status last verified
- Jul 2025
- First submitted
- 13 Sep 2019
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan
Publications
Kayani B, Konan S, Tahmassebi J, Oussedik S, Moriarty PD, Haddad FS. A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty. Trials. 2020 Feb 18;21(1):194. doi: 10.1186/s13063-020-4123-8.
PubMed 32070406
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Control Trial Comparing Mako Robotic-arm Assisted Functionally Aligned Total Knee Arthroplasty Versus Mako Robotic-arm Assisted Mechanically Aligned Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04092153
- Acronym / sponsor ID
- 17/0721
- Conditions
- Osteo Arthritis Knee, Osteoarthritis, Surgery
- Keywords
- total knee arthroplasty, total knee replacement, functional alignment, kinematic alignment, robotic surgery, mako robot, makoplasty, patient outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- 28 Dec 2018 (actual)
- Primary completion
- 6 Feb 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 17 Sep 2019 (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.
This study evaluates outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty [MA TKA] versus robotic-arm assisted functionally aligned total knee arthroplasty [FA TKA]. Half the study will receive MA TKA and half will receive FA TKA.
Detailed description
Total knee arthroplasty [TKA] is an estabilshed treatment for symptomatic end-stage knee osteoarthritis, but there is a higher disatisfaction rate when compared to total hip arthroplasty. The exact aetiology of this is not clear but recent studies have shown one possible reason to be conventional TKA with mechanical alignment [MA] may force the knee into an unnatural position. This may lead to altered knee anatomy and kinematics that may compromise patient satisfaction.
Total knee arthroplasty using functional alignment [FA] aims to restore the patient's prearthritic knee anatomy and native joint kinematics. Early clinical and functional outcome studies have reported promising outcomes in TKA with FA but results of longer term studies have not yet been published.
There are very few prospective studies exploring clinical and radiological outcomes in MA versus FA for TKA. It is possible to improve on previous studies by recording a more comprehensive range of clinical and functional outcome measures, blinding patients and observers recording outcomes of interest, and using longer follow-up times.
Robotic-arm assistance can be used to improve the accuracy of implant positioning. Clinical and functional outcomes should also be correlated to longer-term outcomes to better establish the "safe zone" for functional alignment. The findings of this study will enable an improved understanding of the clinical and functional benefits of FA compared to MA. These outcomes will improve our understanding of the optimal TKA alignment with possible improved outcomes; improved cost-effectiveness by reduced revisions and better patient satisfaction and function; and improved long-term implant survival.
100 patients will be enrolled in a 1:1 ratio between the two treatment groups. Trial patient will be allocated to either the MA TKA ['Control group'] or to the FA TKA ['Investigation group']. Outcomes will be recorded at specific milestones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically aligned | Active comparator | Device: Total knee arthroplasyNeutral limb alignment irrespective of the patient's native knee anatomy and joint mechanics |
| Functionally aligned | Experimental | Device: Total knee arthroplasyRestore the patient's own pre-arthritic knee anatomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has symptomatic knee osteoarthritis requiring primary TKA
- Patient and surgeon are in agreement that TKA is the most appropriate treatment
- Patient is fit for surgical intervention following review by surgeon and anaesthetist
- Patient is between 18-80 years of age at time of surgery
- Gender: male and female
Key exclusion criteria (10 listed)
- Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis
- Patient has bone loss that requires augmentation
- Patient is not medically fit for surgical intervention
- Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA
- Patient is immobile or has another neurological condition affecting musculoskeletal function
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 arthroplasySurgical implantation of prosthetic knee using robotic-arm assist | Device | Functionally aligned, Mechanically aligned |
Primary outcome
Western Ontario and Mcmaster Universities Arthritis Index (WOMAC)
Time frame: 2 years post-intervention
Patient recorded outcome questionnaire evaluating pain, stiffness and disability in affected joint
15 secondary outcomes
Lower limb alignment
Time frame: pre op and 6 weeks post op
Operating time
Time frame: interoperative
Time to discharge
Time frame: Documented when participant leaves hospital, an average of 72 -96 hours
Forgotten Joint Score (FJS)
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Oxford Knee Score (OKS)
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Short form health survey of 12 items (SF-12),
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
University of California at Los Angeles knee (UCLA)
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
Time frame: Pre-op; 6 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Use of mobility aids
Time frame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Mobilisation distance
Time frame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Range of movement
Time frame: inpatient admission and postoperatively at 6 weeks, 6 months, 1 year and 2 years
radiosteriometric analysis (RSA)
Time frame: postoperatively at 2 weeks, 6 weeks, 6 months, 1 year, and 2 years
Gait analysis
Time frame: performed postoperatively at 6 months and 1 year postoperatively
Complications
Time frame: during inpatient admission and postoperatively at 6- weeks, 6 months, 1 year and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 32070406Kayani B, Konan S, Tahmassebi J, Oussedik S, Moriarty PD, Haddad FS. A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty. Trials. 2020 Feb 18;21(1):194. doi: 10.1186/s13063-020-4123-8.
- Individual participant dataSharing planned: No. No plan
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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.
Fares S Haddad study chair
University College London Hospitals
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 arthroplasy in people with Osteo Arthritis Knee and Osteoarthritis, run by University College, London at 1 site in United Kingdom.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jul 2025. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Arthritis Index (WOMAC) (time frame: 2 years post-intervention). 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 NCT04092153, which also lists 1 linked publication.
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 9 Jul 2025.