Recruiting NCT05459948
The Medacta GMK SpheriKA Post-Marketing Surveillance Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GMK SpheriKA.
- Who it may be relevant to
- Registry conditions: Arthropathy, Knee Replacement. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Italy, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study
Overview
This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.
Detailed description
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.
Interventions
- Device GMK SpheriKA
The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique
Primary outcome measures
- Primary objective will be evaluated with the Forgotten Joint score (FJS). [Time frame: 6 weeks, from 1 to 10 years annually]
Secondary outcome measures (6)
- patient-reported outcomes 1 [Time frame: 6 weeks, from 1 to 10 years annually]
- Satisfaction and Expectations questionaires [Time frame: 6 weeks, from 1 to 10 years annually]
- Radiological outcomes [Time frame: pre-op, 6weeks, 1, 2,5,10 years]
- Adverse events [Time frame: during surgical operation, 6weeks, 1,2,5,10 years]
- Limb alignment [Time frame: on preoperative and 6-week x-rays]
- Lateral uncoverage of the anterior femoral resection [Time frame: During Surgical Operation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Centre de l'Arthrose — Mérignac
- Clinique de l'Union — Saint-Jean
Italy · 1 center
- Humanitas Castelli — Bergamo
Switzerland · 1 center
- Gelenkzentrum Winterthur — Winterthur
Identifiers
NCT: NCT05459948 · P.02.025.02