Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty (KA vs MA)

July 13, 2022 updated by: Medacta USA

A Prospective, Randomized, Single-Blinded, Multi-Center, Clinical Trial Comparing Kinematic Alignment vs. Mechanical Alignment Using Medially-Stabilized Knee (GMK Sphere) And Patient-Specific Cutting Guides (MyKnee) For Total Knee Arthroplasty

This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients using patient reported outcomes, clinical and functional performance tests and radiographic analyses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, randomized, single-blinded, multi-center trial comparing Kinematic Alignment vs Mechanical Alignment in TKA patients with Medacta GMK Sphere knee system using patient specific instrumentation Medacta MyKnee. Patients will be assessed a pre-operative, operative and interim post-operative visits, week 6, month 6 and 1,2,5 & 10 years. There will be a phone survey follow up at year 3,4,6,7,8,& 9.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF).

    • Ability to understand and provide written authorization for use and disclosure of personal health information.
    • Subject who are able and willing to comply with the study protocol and follow-up visits.
    • Must be 21 years or older to participate, and less than 80 years old.
    • Subjects must have osteoarthritis knee disease in the affected knee compliant with the FDA-approved indications for use of GMK Sphere knee system and MyKnee cutting blocks.
    • Patients who are candidates for Total Knee Arthroplasty and are determined to undergo a TKA using the Medacta GMK Sphere implant and MyKnee cutting blocks will be offered enrollment.
    • Subjects must be able to return for the follow-up appointments, and have the mental capacity to cooperate and complete PRO questionnaires, physical exam and radiographs.

Exclusion Criteria:

  • • Cases of extreme bone loss requiring an augmented femoral or tibial implant and chronic ligamentous laxity requiring a constrained implant

    • The patient has a fixed flexion deformity of ≥15°
    • The patient has less than 90° of flexion
    • Patient is morbidly obese (BMI ≥40)
    • Patient with inflammatory arthritis
    • History of prior deep knee infection
    • History of alcoholism or drug abuse
    • Currently on chemotherapy or radiation therapy for neoplastic disease
    • Patient currently on immunosuppressive medications including steroids except when, (a) steroid use is less than 10mg daily, (b) other immunosuppressive medications are held for appropriate time, for example Adalimumab is held 2 weeks prior and 2 weeks after surgery
    • History of known sensitivity or allergy to materials used in orthopedic implants, specifically Titanium and Cobalt-Chrome alloys
    • Habitual use of narcotic pain medications prior to surgery (more than 2 doses daily and chronic use of a minimum 3 months)
    • History of metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis (e.g., Osteomalacia, Ricketts)
    • History of chronic pain issues for reasons other than knee joint pain. If the type of pain affects activities of daily living, do not enroll. If the pain is intermittent and does not affect activities of daily living, it is OK to enroll. Fibromyalgia is exclusionary.
    • Women who are pregnant
    • Patient with unstable psychiatric illness or psychosis is excluded. (Patients with stable anxiety or depression can be enrolled if PI determines that the condition does not adversely affect study outcomes & requirements)
    • Any patient, in the opinion of the investigator, is unable to fully comply with the surgical, rehabilitation, or follow-up aspects of this procedure.
    • Prior surgery on the target knee other than arthroscopy and/or arthroscopically-assisted ligament reconstruction
    • Prior high tibial osteotomy (HTO) or femoral osteotomy
    • Malunion of fracture of a tibia or femur
    • Patient with a neuromuscular or neurosensory deficiency
    • Patient with history of knee fusion in the affected joint

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Unrestricted Kinematic Alignment
Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides
Procedure: Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides
MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Unrestricted KA places the implant in a custom position for each patient, completely matching individual anatomy and restoring natural alignment to that of the prearthritic knee.
Active Comparator: Restricted Kinematic Alignment
Mechanical Alignment and restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides
Procedure: Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides
MA places the implant in an average position for all patients based on pre-determined definition of acceptable knee alignment and has become the most common surgical approach for TKA and Restricted KA places the implant in a custom position for each patient, closely matching with anatomy and natural alignment of the individual's knee.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Forgotten Joint Score
Time Frame: Post operative 4-132 months
Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Knee Forgotten Joint Score
Post operative 4-132 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline to Post operative 4-132 months
Assessment of improvement of activity levels following knee replacement surgery using the KOOS
Baseline to Post operative 4-132 months
Change from baseline in Knee Society Score
Time Frame: Baseline to Post operative 4-132 months
Patient specific patient outcomes scoring
Baseline to Post operative 4-132 months
Change from baseline in Knee Society Score
Time Frame: Baseline to Post operative 4-132 months
Clinical Exam Range of Motion, Stability and Alignment
Baseline to Post operative 4-132 months
Change from baseline in PROMIS
Time Frame: Baseline to Post operative 4-132 months
Pain Intensity, Pain Interference, and physical function scoring
Baseline to Post operative 4-132 months
Change in Baseline in Knee Alignment
Time Frame: Baseline to Post operative 4-132 months
Determined by radiographic analysis measured by angle of degrees
Baseline to Post operative 4-132 months
Change from Baseline of Implant Position Fixation
Time Frame: Baseline to Post operative 4-132 months
Determined by radiographic analysis by measure radio lucent lines in millimeters
Baseline to Post operative 4-132 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: Baseline
Height in inches, weight in pounds to determine BMI
Baseline
Number of male or female patients
Time Frame: Baseline
Gender description male or female
Baseline
Occurrence of prior medical and surgical history
Time Frame: Baseline
Medical and surgical history of patient prior to knee surgery
Baseline
Implant demographics
Time Frame: day of surgery
Implant femoral and tibial size and poly thickness
day of surgery
Anesthetic
Time Frame: day of surgery
type of anesthesia used during surgery
day of surgery
Length of Hospital Stay
Time Frame: day of surgery
Length of stay in hours
day of surgery
Frequency of Facility type used for knee surgery
Time Frame: day of surgery
Type of facility used for knee surgery
day of surgery
Tourniquet Time
Time Frame: day of surgery
Tourniquet time in minutes
day of surgery
Number of implant failures, implant survival status
Time Frame: Post operative 4-132 months
Re-operations, revisions, removals, and device related adverse events
Post operative 4-132 months
Age of patient
Time Frame: Baseline
Date of birth
Baseline
Pain medication associated with study knee
Time Frame: Baseline to Post operative 4-132 months
Pain medication and use of narcotics for the study knee
Baseline to Post operative 4-132 months
Return to Work/Activity questionnaire
Time Frame: Baseline to Post operative 4-132 months
Assessment of ability to return to work or other activities following surgery
Baseline to Post operative 4-132 months
Estimated Blood Loss
Time Frame: day of surgery
Volume of blood loss during surgery
day of surgery
Type of Surgical Technique
Time Frame: day of surgery
Mechanical, Restricted Kinematic, Unrestricted Kinematic and tendon release
day of surgery
Length of Surgery
Time Frame: day of surgery
Time in minutes skin to skin
day of surgery
Complications
Time Frame: Baseline to Post operative 4-132 months
Assess adverse events and Serious Adverse Events
Baseline to Post operative 4-132 months
Assisted device usage
Time Frame: Post operative 4-14 months
Cessation of assisted device usage by date
Post operative 4-14 months
Pain, Satisfaction, Narcotics and Function expectations
Time Frame: 36-108 months
Custom Health Survey
36-108 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medacta USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Rena Mandino, Associate Director, Clinical Research Medacta USA

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MUSA-K-KA-001

Drug and device information, study documents

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.

No

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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