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

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• Status: Withdrawn
• Conditions: Knee Osteoarthritis; Knee Pain Chronic
• Intervention / Treatment: Procedure: Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides; Procedure: Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides

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: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change from baseline in Forgotten Joint Score	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

Outcome Measure	Measure Description	Time Frame
Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)	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	Patient specific patient outcomes scoring	Baseline to Post operative 4-132 months
Change from baseline in Knee Society Score	Clinical Exam Range of Motion, Stability and Alignment	Baseline to Post operative 4-132 months
Change from baseline in PROMIS	Pain Intensity, Pain Interference, and physical function scoring	Baseline to Post operative 4-132 months
Change in Baseline in Knee Alignment	Determined by radiographic analysis measured by angle of degrees	Baseline to Post operative 4-132 months
Change from Baseline of Implant Position Fixation	Determined by radiographic analysis by measure radio lucent lines in millimeters	Baseline to Post operative 4-132 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Height in inches, weight in pounds to determine BMI	Baseline
Number of male or female patients	Gender description male or female	Baseline
Occurrence of prior medical and surgical history	Medical and surgical history of patient prior to knee surgery	Baseline
Implant demographics	Implant femoral and tibial size and poly thickness	day of surgery
Anesthetic	type of anesthesia used during surgery	day of surgery
Length of Hospital Stay	Length of stay in hours	day of surgery
Frequency of Facility type used for knee surgery	Type of facility used for knee surgery	day of surgery
Tourniquet Time	Tourniquet time in minutes	day of surgery
Number of implant failures, implant survival status	Re-operations, revisions, removals, and device related adverse events	Post operative 4-132 months
Age of patient	Date of birth	Baseline
Pain medication associated with study knee	Pain medication and use of narcotics for the study knee	Baseline to Post operative 4-132 months
Return to Work/Activity questionnaire	Assessment of ability to return to work or other activities following surgery	Baseline to Post operative 4-132 months
Estimated Blood Loss	Volume of blood loss during surgery	day of surgery
Type of Surgical Technique	Mechanical, Restricted Kinematic, Unrestricted Kinematic and tendon release	day of surgery
Length of Surgery	Time in minutes skin to skin	day of surgery
Complications	Assess adverse events and Serious Adverse Events	Baseline to Post operative 4-132 months
Assisted device usage	Cessation of assisted device usage by date	Post operative 4-14 months
Pain, Satisfaction, Narcotics and Function expectations	Custom Health Survey	36-108 months

Collaborators and Investigators

• Sponsor: Medacta USA
• Investigators: Study Director: Rena Mandino, Associate Director, Clinical Research Medacta USA

Study record dates

Study Major Dates

• Study Start (Anticipated): January 5, 2020
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): April 5, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID 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