Clinical trial NCT05461638: Kinematic Alignment vs Mechanical Alignment for Total Knee Arthroplasty
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Knee Pain Chronic
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in Forgotten Joint Score
timeFrame: Post operative 4-132 months
Secondary outcomes:
measure: Change from baseline in Knee Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline to Post operative 4-132 months
measure: Change from baseline in Knee Society Score
timeFrame: Baseline to Post operative 4-132 months
measure: Change from baseline in Knee Society Score
timeFrame: Baseline to Post operative 4-132 months
measure: Change from baseline in PROMIS
timeFrame: Baseline to Post operative 4-132 months
measure: Change in Baseline in Knee Alignment
timeFrame: Baseline to Post operative 4-132 months
measure: Change from Baseline of Implant Position Fixation
timeFrame: Baseline to Post operative 4-132 months
Other outcomes:
measure: Number of implant failures, implant survival status
timeFrame: Post operative 4-132 months
measure: Age of patient
timeFrame: Baseline
measure: Number of male or female patients
timeFrame: Baseline
measure: Demographics
timeFrame: Baseline
measure: Occurrence of prior medical and surgical history
timeFrame: Baseline
measure: Pain medication associated with study knee
timeFrame: Baseline to Post operative 4-132 months
measure: Return to Work/Activity questionnaire
timeFrame: Baseline to Post operative 4-132 months
measure: Anesthetic
timeFrame: day of surgery
measure: Estimated Blood Loss
timeFrame: day of surgery
measure: Implant demographics
timeFrame: day of surgery
measure: Type of Surgical Technique
timeFrame: day of surgery
measure: Length of Surgery
timeFrame: day of surgery
measure: Length of Hospital Stay
timeFrame: day of surgery
measure: Tourniquet Time
timeFrame: day of surgery
measure: Frequency of Facility type used for knee surgery
timeFrame: day of surgery
measure: Complications
timeFrame: Baseline to Post operative 4-132 months
measure: Assisted device usage
timeFrame: Post operative 4-14 months
measure: Pain, Satisfaction, Narcotics and Function expectations
timeFrame: 36-108 months
Locations:
Study officials:
affiliation: Associate Director, Clinical Research Medacta USA
name: Rena Mandino
role: STUDY_DIRECTOR
References: