Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty

NCT05461638 | Withdrawn

• 1 other identifier: MUSA-K-KA-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)

  Baseline to Post operative 4-132 months

• Change from baseline in Knee Society Score

  Baseline to Post operative 4-132 months

• Change from baseline in Knee Society Score

  Baseline to Post operative 4-132 months

• Change from baseline in PROMIS

  Baseline to Post operative 4-132 months

• Change in Baseline in Knee Alignment

  Baseline to Post operative 4-132 months

Other Outcomes (18)

• Number of implant failures, implant survival status

  Post operative 4-132 months

• Age of patient

  Baseline

• Number of male or female patients

  Baseline

Study Arms (2)

Unrestricted Kinematic Alignment

ACTIVE COMPARATOR

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

Restricted Kinematic Alignment

ACTIVE COMPARATOR

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

Interventions

Mechanical Alignment and Unrestricted Kinematic Alignment using Medacta GMK Sphere with MyKnee Custom guides PROCEDURE

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.

Unrestricted Kinematic Alignment

Mechanical Alignment and Restricted Kinematic Alignment using Medacta GMK Sphere with custom cutting guides PROCEDURE

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.

Restricted Kinematic Alignment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Medacta USA: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rena Mandino

  Associate Director, Clinical Research Medacta USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: July 18, 2022
• Study Start: January 5, 2020
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07