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This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMK SpheriKA | Device | The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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281 participants are planned for the entire project (all sites combined). Patients requiring "GMK® SpheriKA" implanted via the kinematic alignment technique will be informed and enrolled during the preoperative visit.
The study is conducted as standard of care treatment and participants will receive the same treatment and undergo the same postoperative assessments as non-participants.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arianna Girardi | Contact | +41 91 696 60 60 | girardi@medacta.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de l'Arthrose | Recruiting | Mérignac | France |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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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 |
| Clinique de l'Union | Recruiting | Saint-Jean | 31240 | France |
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| Humanitas Castelli | Recruiting | Bergamo | Italy |
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| Gelenkzentrum Winterthur | Recruiting | Winterthur | Switzerland |
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