Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty

NCT ID: NCT05461638

Last Updated: 2022-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-05
• Study Completion Date: 2022-04-05

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.

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.

Conditions

Knee Osteoarthritis; Knee Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unrestricted Kinematic Alignment

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Restricted Kinematic Alignment

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medacta USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rena Mandino

Role: STUDY_DIRECTOR

Associate Director, Clinical Research Medacta USA

Other Identifiers

MUSA-K-KA-001

Identifier Type: -

Identifier Source: org_study_id