The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Medacta International SA281 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

281

Conditions

Arthropathy Knee Replacement

Interventions

GMK SpheriKADEVICE

The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (4)

Centre de l'Arthrose

Mérignac, France

RECRUITING

Clinique de l'Union

Saint-Jean, France

RECRUITING

Humanitas Castelli

Bergamo, Italy

RECRUITING

Outcomes

Primary Outcomes

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 annually

Secondary Outcomes

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 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.

Time frame: 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

Time frame: pre-op, 6weeks, 1, 2,5,10 years

Adverse events

Adverse events (type of complications, dependent or not from the device etc)

Time frame: during surgical operation, 6weeks, 1,2,5,10 years

Central Contacts

Arianna Girardi

CONTACT

+41 91 696 60 60 girardi@medacta.ch

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.