Knee Osteoarthritis, Knee Pain Chronic
Conditions
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.
Interventions
PROCEDUREMechanical 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.
PROCEDUREMechanical 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.
Sponsors
Medacta USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Forgotten Joint Score | Post operative 4-132 months | Assessment of the improvement of joint specific outcomes following knee replacement surgery using the Knee Forgotten Joint Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Knee Osteoarthritis Outcome Score (KOOS) | Baseline to Post operative 4-132 months | Assessment of improvement of activity levels following knee replacement surgery using the KOOS |
| Change from baseline in Knee Society Score | Baseline to Post operative 4-132 months | Patient specific patient outcomes scoring |
| Change from baseline in PROMIS | Baseline to Post operative 4-132 months | Pain Intensity, Pain Interference, and physical function scoring |
| Change in Baseline in Knee Alignment | Baseline to Post operative 4-132 months | Determined by radiographic analysis measured by angle of degrees |
| Change from Baseline of Implant Position Fixation | Baseline to Post operative 4-132 months | Determined by radiographic analysis by measure radio lucent lines in millimeters |
Other
| Measure | Time frame | Description |
|---|---|---|
| Return to Work/Activity questionnaire | Baseline to Post operative 4-132 months | Assessment of ability to return to work or other activities following surgery |
| Anesthetic | day of surgery | type of anesthesia used during surgery |
| Estimated Blood Loss | day of surgery | Volume of blood loss during surgery |
| Implant demographics | day of surgery | Implant femoral and tibial size and poly thickness |
| Type of Surgical Technique | day of surgery | Mechanical, Restricted Kinematic, Unrestricted Kinematic and tendon release |
| Length of Surgery | day of surgery | Time in minutes skin to skin |
| Number of implant failures, implant survival status | Post operative 4-132 months | Re-operations, revisions, removals, and device related adverse events |
| Tourniquet Time | day of surgery | Tourniquet time in minutes |
| Frequency of Facility type used for knee surgery | day of surgery | Type of facility used for knee surgery |
| Complications | Baseline to Post operative 4-132 months | Assess adverse events and Serious Adverse Events |
| Assisted device usage | Post operative 4-14 months | Cessation of assisted device usage by date |
| Pain, Satisfaction, Narcotics and Function expectations | 36-108 months | Custom Health Survey |
| Length of Hospital Stay | day of surgery | Length of stay in hours |
| Age of patient | Baseline | Date of birth |
| Number of male or female patients | Baseline | Gender description male or female |
| Demographics | Baseline | Height in inches, weight in pounds to determine BMI |
| Occurrence of prior medical and surgical history | Baseline | Medical and surgical history of patient prior to knee surgery |
| Pain medication associated with study knee | Baseline to Post operative 4-132 months | Pain medication and use of narcotics for the study knee |
Outcome results
None listed