The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Study Overview
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Brief Summary
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This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.

Detailed Description
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The aim of the current study is to collect clinical and radiological data to monitor the performances of the GMK® SpheriKA Knee Prosthesis implanted via the kinematic alignment technique.

Official Title
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Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study

Conditions
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Arthropathy, Knee Replacement

Intervention / Treatment
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* Device: GMK SpheriKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to sign the informed consent. Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations. Patients 18 - 80 years of age at the time of surgery. Patients requiring a primary total knee replacement (on label use). Patients with intact collateral ligaments. Exclusion Criteria: Patients with inflammatory arthritis. Morbidly obese patients, with a body mass index (BMI) > 40. Patients with a history of total or unicompartmental reconstruction of the affected joint. Patients that have had a high tibial osteotomy or femoral osteotomy. Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. Patients with a systemic or metabolic disorder leading to progressive bone deterioration. Patients that are immunologically compromised or receiving chronic steroids (> 30 days). Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis. Patients with an active or suspected latent infection in or surrounding the knee joint. Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GMK SpheriKA|The first objective is to study the FJS of patients who were implanted a GMK® SpheriKA knee prosthesis using the kinematic alignment technique|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective will be evaluated with the Forgotten Joint score (FJS). | study the efficacy of the treatment to make the patient forget the presence of the artificial joint in everyday life. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities | 6 weeks, from 1 to 10 years annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient-reported outcomes 1 | Oxford Knee Score: The OKS is a patient reported outcome measure that consists of 12 questions about an individual's level of function, activities of daily living and how they have been affected by pain over the preceding four weeks | 6 weeks, from 1 to 10 years annually | 
| Satisfaction and Expectations questionaires | Satisfaction and Expectations questionaires Patient reported satisfaction and expectations answering some questions of the satisfaction and expectation knee society score, the goal is to collect all final answers and have an overview on how the patient feels. Patient Expectations is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. Patient Satisfaction is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. | 6 weeks, from 1 to 10 years annually | 
| Radiological outcomes | Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis | pre-op, 6weeks, 1, 2,5,10 years | 
| Adverse events | Adverse events (type of complications, dependent or not from the device etc) | during surgical operation, 6weeks, 1,2,5,10 years | 
| Limb alignment | Limb alignment will be measured: mMPTA (°), mLDFA (°) and joint line (HKA) will be recorded. HKA = Hip-Knee-ankle angle measured in degrees mMPTA = mechanical medial proximal tibial angle measured in degrees mLDFA = mechanical lateral distal femoral angle measured in degrees | on preoperative and 6-week x-rays | 
| Lateral uncoverage of the anterior femoral resection | Measurement of the lateral uncoverage of the anterior femoral resection measured in mm | During Surgical Operation |