The Medacta GMK SpheriKA Post-Marketing Surveillance Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMedacta International SA
About this trial
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GMK SpheriKA
DeviceThe first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
6 weeks, from 1 to 10 years annuallySecondary outcomes
1
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
Time frame
6 weeks, from 1 to 10 years annually2
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.
Time frame
6 weeks, from 1 to 10 years annually3
Radiological outcomes
Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis
Time frame
pre-op, 6weeks, 1, 2,5,10 years4
Adverse events
Adverse events (type of complications, dependent or not from the device etc)
Time frame
during surgical operation, 6weeks, 1,2,5,10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov