The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

Study Overview
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Brief Summary
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This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

Official Title
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A Prospective, Multicentre, International, Post-marketing, Longitudinal, Observational Cohort Study to Monitor the Performances of GMK Sphere Cementless Knee Prosthesis

Conditions
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Arthritis, Traumatic Arthritis, Rheumatoid Arthritis, Poly-arthritis, Avascular Necrosis

Intervention / Treatment
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* Device: GMK Sphere cementless Knee Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis Patients between the age of 18 and 80 at the time of consent Listed for total knee replacement surgery. Patients who are willing and able to give informed written consent Exclusion Criteria: Progressive local or systemic infection Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems Patient whose BMI exceeds 40 Any case not described in the inclusion criteria

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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GMK Sphere cementless Knee Replacement|Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Kaplan Meier method | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome: Knee Society score | Knee Society Score (KSS): evaluates pain, in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability. | Preop and 1, 2, 5, 10 years postop | 
| Patient-reported outcome: Forgotten Joint Score | Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to forget about their affected joint after surgery or treatment.It 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 | 1, 2, 5, 10 years postop | 
| Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence | Presence of radiolucencies, migration, loosening, subsidence | Immediately postop + 1, 2, 5, 10 years postop | 
| Intraoperative and postoperative Adverse events | Intraoperative and postoperative adverse events | Intraop + Immediately postop + 1, 2, 5, 10 years postop |