Arthritis, Avascular Necrosis, Poly-arthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.
Interventions
DEVICEGMK Sphere cementless Knee Replacement
Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement
Sponsors
Medacta International SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 10 years | Kaplan Meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome: Knee Society score | Preop and 1, 2, 5, 10 years postop | 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. |
| Patient-reported outcome: Forgotten Joint Score | 1, 2, 5, 10 years postop | 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 |
| Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence | Immediately postop + 1, 2, 5, 10 years postop | Presence of radiolucencies, migration, loosening, subsidence |
| Intraoperative and postoperative Adverse events | Intraop + Immediately postop + 1, 2, 5, 10 years postop | Intraoperative and postoperative adverse events |
Countries
France, Switzerland
Outcome results
None listed