Back to resultsFunction, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
Primary Purpose
Knee Replacement, Total, Pain, Postoperative, Functional Independence
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Total Knee Replacement
Sponsored by
About this trial
This is an interventional treatment trial for Knee Replacement, Total
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- North York General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Manual Adjusted Mechanical Alignment
Robotic Assisted Adjusted Mechanical Alignment
Robotic Assisted Kinematic Alignment: (Joint line restoration)
Arm Description
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
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
-- 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
Outcomes
Primary Outcome Measures
Function
Oxford knee score
Secondary Outcome Measures
Quality of Life following knee surgery
EuroQol 5D index
Quality of Life following knee surgery
EuroQol 5D index
Quality of Life following knee surgery
EuroQol 5D index
Quality of Life following knee surgery
EuroQol 5D index
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Pain intensity and effectiveness of analgesics
Brief Pain Inventory-Short Form - Pain Severity Index
Satisfaction with knee surgery
Forgotten Joint Score
Satisfaction with knee surgery
Forgotten Joint Score
Satisfaction with knee surgery
Forgotten Joint Score
Satisfaction with knee surgery
Forgotten Joint Score
Satisfaction with knee surgery
Forgotten Joint Score
Function
Oxford knee score
Function
Oxford knee score
Function
Oxford knee score
Function
Oxford knee score
Full Information
NCT ID
NCT05490186
First Posted
December 7, 2021
Last Updated
August 3, 2022
Sponsor
North York General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05490186
Brief Title
Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
Official Title
Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North York General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Replacement, Total, Pain, Postoperative, Functional Independence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual Adjusted Mechanical Alignment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Robotic Assisted Adjusted Mechanical Alignment
Arm Type
Experimental
Arm Description
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
Arm Title
Robotic Assisted Kinematic Alignment: (Joint line restoration)
Arm Type
Experimental
Arm Description
-- 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
Intervention Type
Procedure
Intervention Name(s)
Total Knee Replacement
Other Intervention Name(s)
Manual Adjusted Mechanical Alignment, Robotic Assisted Adjusted Mechanical Alignment, Robotic Assisted Kinematic Alignment: (Joint line restoration)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Function
Description
Oxford knee score
Time Frame
post-operatively 1 year
Secondary Outcome Measure Information:
Title
Quality of Life following knee surgery
Description
EuroQol 5D index
Time Frame
post-operatively at 2 years
Title
Quality of Life following knee surgery
Description
EuroQol 5D index
Time Frame
post-operatively at 6 weeks
Title
Quality of Life following knee surgery
Description
EuroQol 5D index
Time Frame
post-operatively at 6 months
Title
Quality of Life following knee surgery
Description
EuroQol 5D index
Time Frame
post-operatively at 1 year
Title
Pain intensity and effectiveness of analgesics
Description
Brief Pain Inventory-Short Form - Pain Severity Index
Time Frame
Post-operatively at 6 weeks
Title
Pain intensity and effectiveness of analgesics
Description
Brief Pain Inventory-Short Form - Pain Severity Index
Time Frame
Post-operatively at 6 months
Title
Pain intensity and effectiveness of analgesics
Description
Brief Pain Inventory-Short Form - Pain Severity Index
Time Frame
Post-operatively at 1 year
Title
Pain intensity and effectiveness of analgesics
Description
Brief Pain Inventory-Short Form - Pain Severity Index
Time Frame
Post-operatively at 2 years
Title
Satisfaction with knee surgery
Description
Forgotten Joint Score
Time Frame
Post-operatively at 6 weeks, 6 months, 1 year and 2 years
Title
Satisfaction with knee surgery
Description
Forgotten Joint Score
Time Frame
Post-operatively at 6 weeks
Title
Satisfaction with knee surgery
Description
Forgotten Joint Score
Time Frame
Post-operatively at 6 months
Title
Satisfaction with knee surgery
Description
Forgotten Joint Score
Time Frame
Post-operatively at 1 year
Title
Satisfaction with knee surgery
Description
Forgotten Joint Score
Time Frame
Post-operatively at 2 years
Title
Function
Description
Oxford knee score
Time Frame
post-operatively at 6 weeks
Title
Function
Description
Oxford knee score
Time Frame
post-operatively at 6 months
Title
Function
Description
Oxford knee score
Time Frame
pre-operatively
Title
Function
Description
Oxford knee score
Time Frame
post-operatively at 2 years
Other Pre-specified Outcome Measures:
Title
Health Care Utilization
Description
unanticipated visits to emergency department, primary care provide, surgeon due to knee surgery
Time Frame
Post-operatively at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mona Sawhney, PhD
Phone
416-756-6000
Email
msawhney@nygh.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Mastrogiacomo, PhD
Email
frank.mastrogiacomo@nygh.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Mastrogiacomo, PhD
Organizational Affiliation
North York General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
North York General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Sawhney, PhD
Phone
416-756-6000
Ext
4988
Email
mona.sawhney@nygh.on.ca
First Name & Middle Initial & Last Name & Degree
Monakshi Sawhney, PhD
First Name & Middle Initial & Last Name & Degree
Frank Mastrogiacomo, PhD, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Shawn Garbedian, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Hossein Mehdian, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Herman Dhotar, MD, FRCSC
First Name & Middle Initial & Last Name & Degree
Kelvin Leung, MN, NP
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis
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