Kinematic Alignment in Total Knee Arthroplasty - a Double-blind Randomised Controlled Trial Between Robotic and Caliper-based Techniques

November 25, 2024 updated by: Samuel Larrivée, Université de Sherbrooke

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:

  1. 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?
  2. Does robotic assisted kinematic knee replacement give better function to patients than traditional knee replacement done with kinematic alignment?
  3. Does robotic assisted kinematic knee replacement decrease pain, improve knee movement and improve knee stability better than traditional knee replacement done with kinematic alignment?
  4. Are there more complications with robotic assisted kinematic knee replacement in comparison to traditional kinematic knee replacement?
  5. 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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Kinematic knee replacement with traditional instruments
Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides
Procedure: Kinematic aligned total knee replacement
Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.
Experimental: Robotic-assisted kinematic knee replacement
Patients will undergo kinematic aligned knee replacement done using robotic assistance
Procedure: Kinematic aligned total knee replacement
Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-operative alignement and 6 months post-operative alignement.
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.
Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative
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.
Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op
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".
Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain visual analog scale
Time Frame: Pre-op, 6 weeks, 6, 12, 24 months
Pain rated on a 10 cm visual analog scale from "no pain" to "worst pain imaginable"
Pre-op, 6 weeks, 6, 12, 24 months
Subjective Assessment Numeric Evaluation Scale (SANE)
Time Frame: Pre-op, 6 weeks, 6, 12, 24 months
Single question evaluation scale asking the patient to rate their knee function from 0 (no function) to 100 (completely normal function)
Pre-op, 6 weeks, 6, 12, 24 months
Knee range of motion
Time Frame: Pre, 6 weeks, 6 and 12 months post-op
Maximum passive flexion and extension measured with goniometer
Pre, 6 weeks, 6 and 12 months post-op
Knee stability
Time Frame: Pre-op, 6 weeks, 6 and 12 months post-op
Anterior drawer, posterior drawer, valgus stress, varus stress. Instability rated for each test 1 to 3 by treating surgeon.
Pre-op, 6 weeks, 6 and 12 months post-op

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-operative procedures
Time Frame: At the time of surgery

During surgery, the knee for additional intra-operative procedures to obtain a stable knee replacement will be noted:

  • Need for ligamentous release - lateral release, medial release, lateral retinaculum release, posterior cruciate ligament release
  • Need for tibial or femoral recut
At the time of surgery
Surgical cost
Time Frame: At the time of surgery
Total cost of implants and equipment used will be calculated at the end of each surgical case.
At the time of surgery
Surgical time
Time Frame: At the time of surgery
The time from first incision to skin closure will be noted at each surgery.
At the time of surgery
Intra-operative complications
Time Frame: At the time of surgery

The incidence of intra-operative complications will be noted:

  • Unplanned ligament injury
  • Neurovascular damage
  • Intra-operative tibial of femoral fracture
  • Any other complications noted during surgery
At the time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Hopital Charles Lemoyne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-958

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymous individual patient data will be shared only with a direct request to the study principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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