Knee Replacement, TotalNCT05490186
Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
A study testing Total Knee Replacement in people with Knee Replacement, Total and Pain, Postoperative, run by North York General Hospital at 1 site in Canada.
Trial summary
There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Replacement, Total, Pain, Postoperative, Functional Independence
- 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
- 261 participants
- Where
- 1 siteCanada
- Study dates
- 16 Nov 2021to 8 Feb 2024
- 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
- undergoing unilateral TKR for the treatment of osteoarthritis
- between the age of 18 and 85 years of age
- able to read, speak and understand English, have a telephone
- are able to provide consent
Who cannot join
- enrolled in another study, are
- undergoing revision surgery or bilateral surgery, and are
- over the age of 85 years. Patients will also be excluded if they
- have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked
Trial locations and contacts
1 site in 1 country.
About this study
There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.
- Being tested
- Total Knee Replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ReplacementProcedure or surgery
Also called Manual Adjusted Mechanical Alignment, Robotic Assisted Adjusted Mechanical Alignment, Robotic Assisted Kinematic Alignment: (Joint line restoration)
Surgical technique for Total knee replacement will be standardized with a MicroPort prosthetic knee joint, patella replacement is optional based on the surgeon's assessment. The participants will receive local anesthetic infiltration by the surgeon, and a similar anesthetic technique with spinal anesthesia using epidural morphine and single shot peripheral nerve blocks. They will receive weight based antibiotics and tranexamic acid. Participants will be randomized to one of three groups. 1)Manual adjusted mechanical knee alignment (usual care) involves the surgeon manually. 2) Robot assisted surgery will include using the ROSA© device from Zimmer©. Robot assisted mechanical alignment aims for neutral alignment of the knee joint. 3) Robot assisted restricted kinematic alignment aims to place the knee joint closer to the participant's anatomical positioning.
| Study group | Role | What they receive |
|---|---|---|
| Manual Adjusted Mechanical Alignment | Active comparator | Usual care:
* Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes
* Distal femoral cut with 3-5 degrees of valgus from the anatomical axis (Based on the angle measurement on the 4 foot standing Xray). Correct for flexion contracture.
* Measure the femoral size with the anterior referencing guides. Use 3 degrees external rotation to the Posterior condylar axis
* Perform anterior, posterior and chamfer cuts with the 4 in 1 in appropriate external rotation
* Extramedullary tibial alignment guide with 3-5 degrees posterior slope, and orthogonal cut to the tibial axis.
* Resect posterior osteophytes
* Place trial components and perform appropriate release/balance the gaps
* Patellar replacement based on surgeon's discretion
* Cementing the components with tourniquet inflation Receives: Procedure: Total Knee Replacement |
| Robotic Assisted Adjusted Mechanical Alignment | Experimental | * Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes
* Place the femoral pins in the proximal incision and the tibial pins 4 finger breadths under the joint line
* Map the knee and perform evaluation
* Assess gaps, adjust the femoral axis to decrease soft tissue release (+/- 2 degrees), correct for flexion contracture
* Verify and perform distal femoral cut, proximal tibial cut orthogonal (90 Degrees) to the tibial axis
* Assess and balance extension gap with appropriate releases
* Remap the posterior condylar axis, assess the flexion space, 3 degrees external rotation to the posterior condylar axis
* Perform anterior, posterior and chamber cuts with the 4 in 1 (appropriate external rotation), followed by posterior osteophyte resection
* Place trial components and balance the knee, soft tissue releases (1-2 mm)
* Patellar replacement based on surgeon's discretion
* Cementing the components with tourniquet inflation Receives: Procedure: Total Knee Replacement |
| Robotic Assisted Kinematic Alignment: (Joint line restoration) | Experimental | -- Midline incision, no tourniquet, medial parapatellar arthrotomy, resect anterior osteophytes
* Place femoral pins in proximal incision, tibial pins 4 finger breadths under joint line
* Map and evaluate the knee, ROM, varus valgus testing at 0 \& 90 degrees flexion
* Distal femoral cut based on cartilage loss on medial and lateral femoral condyle (9mm total cut/condyle).
* Perform distal femoral cut, maintain the joint line (femoral axis +/- 5 degrees)
* Perform proximal tibial cut within +/- 3 degrees, balance the gaps, differential between medial and lateral gaps = 1- 3mm.
* Assess extension space, resect posterior osteophytes
* Remap posterior condylar axis, place 4 in 1 at 0 degrees to the post condylar axis (aim = 9mm posterior condylar cuts)
* Resect posterior osteophytes, place trial components. Adjust cuts to achieve a balanced knee, maintain HKA axis +/- 3 degrees
* Patellar replacement per surgeon discretion
* Cement the components with tourniquet inflation Receives: Procedure: Total Knee Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Function
Oxford knee score
Measured: post-operatively 1 year
Secondary outcomes (17)
Quality of Life following knee surgery
EuroQol 5D index
Measured: post-operatively at 2 years
Quality of Life following knee surgery
EuroQol 5D index
Measured: post-operatively at 6 weeks
Quality of Life following knee surgery
EuroQol 5D index
Measured: post-operatively at 6 months
Quality of Life following knee surgery
EuroQol 5D index
Measured: post-operatively at 1 year
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Measured: Post-operatively at 6 weeks
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Measured: Post-operatively at 6 months
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Measured: Post-operatively at 1 year
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Measured: Post-operatively at 2 years
Satisfaction with knee surgery
Forgotten Joint Score
Measured: Post-operatively at 6 weeks, 6 months, 1 year and 2 years
Satisfaction with knee surgery
Forgotten Joint Score
Measured: Post-operatively at 6 weeks
Satisfaction with knee surgery
Forgotten Joint Score
Measured: Post-operatively at 6 months
Satisfaction with knee surgery
Forgotten Joint Score
Measured: Post-operatively at 1 year
Satisfaction with knee surgery
Forgotten Joint Score
Measured: Post-operatively at 2 years
Function
Oxford knee score
Measured: post-operatively at 6 weeks
Function
Oxford knee score
Measured: post-operatively at 6 months
Function
Oxford knee score
Measured: pre-operatively
Function
Oxford knee score
Measured: post-operatively at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start16 Nov 2021
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Why it stopped: The study was prematurely terminated due to a long pause in study activities and significant missing participant data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement, TotalStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- North York General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Rahmat, North York General Hospital
- Investigators
- Frank Mastrogiacomo, PhD, Principal investigator, North York General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490186
- Sponsor's protocol ID
- NYGH REB #21-0043
- Status last verified
- May 2025
- First submitted
- 7 Dec 2021
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Knowledge translation will occur utilizing a variety of mechanisms. The results of this study will be disseminated at the Canadian Orthopaedic Association conference. They will also be published in an high impact journal. At the provincial level, the data from this study will be shared with Health Quality Ontario, as a requirement of the bundled care program. At the local level, the investigators will disseminate the results of this study as aggregate data at North York General Hospital with to the health care practitioners and administrators involved with caring for the arthroplasty patient population.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
- ClinicalTrials.gov ID
- NCT05490186
- Acronym / sponsor ID
- NYGH REB #21-0043
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated due to a long pause in study activities and significant missing participant data.
- Enrolment
- 261 participants (actual)
- Lead sponsor
- North York General HospitalUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 5 Aug 2022 (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.
There are many factors that can influence patient satisfaction and patient related outcomes following total knee replacement including the surgical alignment of the joint components. Historically, total knee replacements have been performed with an aim aiming to achieve neutral alignment or a mechanical weight axis in the lower extremity . However, only 0.1 % of the population have a pre-surgical anatomical neutral alignment, and therefore the constitutional anatomy of the patient is neglected. There is a growing trend to return patients back their anatomical constitutional alignment after a knee replacement, referred to as Kinematic Alignment using robotics. The aim of this randomized controlled trial is to examine how mechanical alignment and kinematic alignment impacts function, pain, mood and fatigue following TKR for the treatment of osteoarthritis. Outcomes will be measured at 6 week, 6 months, 1 year and 2 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Adjusted Mechanical Alignment | Active comparator | Procedure: Total Knee ReplacementUsual care: * Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes * Distal femoral cut with 3-5 degrees of valgus from the anatomical axis (Based on the angle measurement on the 4 foot standing Xray). Correct for flexion contracture. * Measure the femoral size with the anterior referencing guides. Use 3 degrees external rotation to the Posterior condylar axis * Perform anterior, posterior and chamfer cuts with the 4 in 1 in appropriate external rotation * Extramedullary tibial alignment guide with 3-5 degrees posterior slope, and orthogonal cut to the tibial axis. * Resect posterior osteophytes * Place trial components and perform appropriate release/balance the gaps * Patellar replacement based on surgeon's discretion * Cementing the components with tourniquet inflation |
| Robotic Assisted Adjusted Mechanical Alignment | Experimental | Procedure: Total Knee Replacement* Midline incision, no tourniquet, medial Parapatellar arthrotomy, resect anterior osteophytes * Place the femoral pins in the proximal incision and the tibial pins 4 finger breadths under the joint line * Map the knee and perform evaluation * Assess gaps, adjust the femoral axis to decrease soft tissue release (+/- 2 degrees), correct for flexion contracture * Verify and perform distal femoral cut, proximal tibial cut orthogonal (90 Degrees) to the tibial axis * Assess and balance extension gap with appropriate releases * Remap the posterior condylar axis, assess the flexion space, 3 degrees external rotation to the posterior condylar axis * Perform anterior, posterior and chamber cuts with the 4 in 1 (appropriate external rotation), followed by posterior osteophyte resection * Place trial components and balance the knee, soft tissue releases (1-2 mm) * Patellar replacement based on surgeon's discretion * Cementing the components with tourniquet inflation |
| Robotic Assisted Kinematic Alignment: (Joint line restoration) | Experimental | Procedure: Total Knee Replacement-- Midline incision, no tourniquet, medial parapatellar arthrotomy, resect anterior osteophytes * Place femoral pins in proximal incision, tibial pins 4 finger breadths under joint line * Map and evaluate the knee, ROM, varus valgus testing at 0 \& 90 degrees flexion * Distal femoral cut based on cartilage loss on medial and lateral femoral condyle (9mm total cut/condyle). * Perform distal femoral cut, maintain the joint line (femoral axis +/- 5 degrees) * Perform proximal tibial cut within +/- 3 degrees, balance the gaps, differential between medial and lateral gaps = 1- 3mm. * Assess extension space, resect posterior osteophytes * Remap posterior condylar axis, place 4 in 1 at 0 degrees to the post condylar axis (aim = 9mm posterior condylar cuts) * Resect posterior osteophytes, place trial components. Adjust cuts to achieve a balanced knee, maintain HKA axis +/- 3 degrees * Patellar replacement per surgeon discretion * Cement the components with tourniquet inflation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing unilateral TKR for the treatment of osteoarthritis
- between the age of 18 and 85 years of age
- able to read, speak and understand English, have a telephone
- are able to provide consent
Key exclusion criteria (4 listed)
- enrolled in another study, are
- undergoing revision surgery or bilateral surgery, and are
- over the age of 85 years. Patients will also be excluded if they
- have a cognitive impairment (as indicated in the medical record) affecting their ability to comprehend the questions being asked
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 ReplacementAlso: Manual Adjusted Mechanical Alignment, Robotic Assisted Adjusted Mechanical Alignment, Robotic Assisted Kinematic Alignment: (Joint line restoration)Surgical technique for Total knee replacement will be standardized with a MicroPort prosthetic knee joint, patella replacement is optional based on the surgeon's assessment. The participants will receive local anesthetic infiltration by the surgeon, and a similar anesthetic technique with spinal anesthesia using epidural morphine and single shot peripheral nerve blocks. They will receive weight based antibiotics and tranexamic acid. Participants will be randomized to one of three groups. 1)Manual adjusted mechanical knee alignment (usual care) involves the surgeon manually. 2) Robot assisted surgery will include using the ROSA© device from Zimmer©. Robot assisted mechanical alignment aims for neutral alignment of the knee joint. 3) Robot assisted restricted kinematic alignment aims to place the knee joint closer to the participant's anatomical positioning. | Procedure or surgery | Manual Adjusted Mechanical Alignment, Robotic Assisted Adjusted Mechanical Alignment, Robotic Assisted Kinematic Alignment: (Joint line restoration) |
Primary outcome
Function
Time frame: post-operatively 1 year
Oxford knee score
17 secondary outcomes
Quality of Life following knee surgery
Time frame: post-operatively at 2 years
Quality of Life following knee surgery
Time frame: post-operatively at 6 weeks
Quality of Life following knee surgery
Time frame: post-operatively at 6 months
Quality of Life following knee surgery
Time frame: post-operatively at 1 year
Pain intensity and effectiveness of analgesics
Time frame: Post-operatively at 6 weeks
Pain intensity and effectiveness of analgesics
Time frame: Post-operatively at 6 months
Pain intensity and effectiveness of analgesics
Time frame: Post-operatively at 1 year
Pain intensity and effectiveness of analgesics
Time frame: Post-operatively at 2 years
Satisfaction with knee surgery
Time frame: Post-operatively at 6 weeks, 6 months, 1 year and 2 years
Satisfaction with knee surgery
Time frame: Post-operatively at 6 weeks
Satisfaction with knee surgery
Time frame: Post-operatively at 6 months
Satisfaction with knee surgery
Time frame: Post-operatively at 1 year
Satisfaction with knee surgery
Time frame: Post-operatively at 2 years
Function
Time frame: post-operatively at 6 weeks
Function
Time frame: post-operatively at 6 months
Function
Time frame: pre-operatively
Function
Time frame: post-operatively at 2 years
Results and safety
The study was stopped early (reason given: The study was prematurely terminated due to a long pause in study activities and significant missing participant data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No. Knowledge translation will occur utilizing a variety of mechanisms. The results of this study will be disseminated at the Canadian Orthopaedic Association conference. They will also be published in an high impact journal. At the provincial level, the data from this study will be shared with Health Quality Ontario, as a requirement of the bundled care program. At the local level, the investigators will disseminate the results of this study as aggregate data at North York General Hospital with to the health care practitioners and administrators involved with caring for the arthroplasty patient population.
Related trials for Knee Replacement, Total
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
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 Mastrogiacomo, PhD principal investigator
North York General Hospital
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 Replacement, Total and Pain, Postoperative, run by North York General Hospital at 1 site in Canada.
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: stopped early, as of the sponsor's last update on 20 May 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 Canada. 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 was stopped early (reason given: The study was prematurely terminated due to a long pause in study activities and significant missing participant data.). Results are not available in the source record.
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?
Function (time frame: post-operatively 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2025.