Clinical trial NCT05459948: The Medacta GMK SpheriKA Post-Marketing Surveillance Study
Official title: Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthropathy
Knee Replacement
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2022-07-15
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

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.

Primary outcomes:
measure: Primary objective will be evaluated with the Forgotten Joint score (FJS).
timeFrame: 6 weeks, from 1 to 10 years annually
Secondary outcomes:
measure: patient-reported outcomes 1
timeFrame: 6 weeks, from 1 to 10 years annually
measure: Satisfaction and Expectations questionaires
timeFrame: 6 weeks, from 1 to 10 years annually
measure: Radiological outcomes
timeFrame: pre-op, 6weeks, 1, 2,5,10 years
measure: Adverse events
timeFrame: during surgical operation, 6weeks, 1,2,5,10 years
measure: Limb alignment
timeFrame: on preoperative and 6-week x-rays
measure: Lateral uncoverage of the anterior femoral resection
timeFrame: During Surgical Operation
Other outcomes:
Locations:
city: Mérignac
country: France
facility: Centre de l'Arthrose
city: Saint-Jean
country: France
facility: Clinique de l'Union
city: Bergamo
country: Italy
facility: Humanitas Castelli
city: Winterthur
country: Switzerland
facility: Gelenkzentrum Winterthur
Study officials:
References: