The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Knee Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459948
• Other study ID #: P.02.025.02
• Status: Recruiting
• Start date: July 30, 2022
• Est. completion date: May 2035

Study information

• Verified date: October 2023
• Source: Medacta International SA
• Contact: Arianna Girardi
• Phone: +41 91 696 60 60
• Email: girardi[@]medacta.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 281
• Est. completion date: May 2035
• Est. primary completion date: May 2035
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy
• Joint Diseases
• Knee Replacement

Intervention

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

Locations

Country	Name	City	State
France	Centre de l'Arthrose	Mérignac
France	Clinique de l'Union	Saint-Jean
Italy	Humanitas Castelli	Bergamo
Switzerland	Gelenkzentrum Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Countries where clinical trial is conducted

France,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks, from 1 to 10 years annually
Secondary	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	6 weeks, from 1 to 10 years annually
Secondary	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.	6 weeks, from 1 to 10 years annually
Secondary	Radiological outcomes	Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis	pre-op, 6weeks, 1, 2,5,10 years
Secondary	Adverse events	Adverse events (type of complications, dependent or not from the device etc)	during surgical operation, 6weeks, 1,2,5,10 years
Secondary	Limb alignment	Limb alignment will be measured: mMPTA (°), mLDFA (°) and joint line (HKA) will be recorded.; HKA = Hip-Knee-ankle angle measured in degrees mMPTA = mechanical medial proximal tibial angle measured in degrees mLDFA = mechanical lateral distal femoral angle measured in degrees	on preoperative and 6-week x-rays
Secondary	Lateral uncoverage of the anterior femoral resection	Measurement of the lateral uncoverage of the anterior femoral resection measured in mm	During Surgical Operation