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Clinical Trials/NCT05490186
NCT05490186TerminatedNot Applicable

Function, Pain, and Alignment Following Knee Replacement for the Treatment of Osteoarthritis

North York General Hospital1 site in 1 country261 target enrollmentStarted: November 16, 2021Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
261
Locations
1
Primary Endpoint
Function
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: Total Knee Replacement (Procedure)

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

Intervention: Total Knee Replacement (Procedure)

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

Intervention: Total Knee Replacement (Procedure)

Outcomes

Primary Outcomes

Function

Time Frame: post-operatively 1 year

Oxford knee score

Secondary Outcomes

  • Function(post-operatively at 2 years)
  • Pain intensity and effectiveness of analgesics(Post-operatively at 2 years)
  • Quality of Life following knee surgery(post-operatively at 1 year)
  • Satisfaction with knee surgery(Post-operatively at 2 years)
  • Quality of Life following knee surgery(post-operatively at 2 years)
  • Quality of Life following knee surgery(post-operatively at 6 weeks)
  • Quality of Life following knee surgery(post-operatively at 6 months)
  • Pain intensity and effectiveness of analgesics(Post-operatively at 6 weeks)
  • Pain intensity and effectiveness of analgesics(Post-operatively at 6 months)
  • Pain intensity and effectiveness of analgesics(Post-operatively at 1 year)
  • Satisfaction with knee surgery(Post-operatively at 6 weeks, 6 months, 1 year and 2 years)
  • Satisfaction with knee surgery(Post-operatively at 6 weeks)
  • Satisfaction with knee surgery(Post-operatively at 6 months)
  • Satisfaction with knee surgery(Post-operatively at 1 year)
  • Function(post-operatively at 6 weeks)
  • Function(post-operatively at 6 months)
  • Function(pre-operatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mary Rahmat

Clinical Trials Manager

North York General Hospital

Study Sites (1)

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