Medacta GMK® SpheriKA and Kinematic Alignment Technique Multicenter, Post-Market Outcome Study

Medacta International SA4 sites in 3 countries281 target enrollmentJuly 30, 2022

ConditionsArthropathy Knee Replacement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Arthropathy
Sponsor: Medacta International SA
Enrollment: 281
Locations: 4
Primary Endpoint: Primary objective will be evaluated with the Forgotten Joint score (FJS).
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 30, 2022

End Date

May 1, 2035

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medacta International SA

Responsible Party

Sponsor

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) \>
•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.

Outcomes

Primary Outcomes

Primary objective will be evaluated with the Forgotten Joint score (FJS).

Time Frame: 6 weeks, from 1 to 10 years annually

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

Secondary Outcomes

Limb alignment(on preoperative and 6-week x-rays)
Satisfaction and Expectations questionaires(6 weeks, from 1 to 10 years annually)
Lateral uncoverage of the anterior femoral resection(During Surgical Operation)
Radiological outcomes(pre-op, 6weeks, 1, 2,5,10 years)
patient-reported outcomes 1(6 weeks, from 1 to 10 years annually)
Adverse events(during surgical operation, 6weeks, 1,2,5,10 years)