The Medacta GMK SpheriKA Post-Marketing Surveillance Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Arthropathy; Knee Replacement
• Intervention / Treatment: Device: GMK SpheriKA

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.

• Study Type: Observational
• Enrollment (Estimated): 281

Contacts and Locations

• Study Contact: Name: Arianna Girardi; Phone Number: +41 91 696 60 60; Email: girardi@medacta.ch

Study Locations

• France
  • Mérignac, France
    • Recruiting
    • Centre de l'arthrose
    • Contact: Charles RIVIERE
  • Saint-Jean, France, 31240
    • Recruiting
    • Clinique de l'Union
    • Contact: David BENZAQUEN, Dr.; Phone Number: +33 05 61 37 87 79; Email: davidbenzaquen@icloud.com
• Italy
  • Bergamo, Italy
    • Recruiting
    • Humanitas Castelli
    • Contact: Vincenzo Madonna
• Switzerland
  • Winterthur, Switzerland
    • Recruiting
    • Gelenkzentrum Winterthur
    • Contact: Peter Koch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Adverse events	Adverse events (type of complications, dependent or not from the device etc)	during surgical operation, 6weeks, 1,2,5,10 years
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
Lateral uncoverage of the anterior femoral resection	Measurement of the lateral uncoverage of the anterior femoral resection measured in mm	During Surgical Operation

Collaborators and Investigators

• Sponsor: Medacta International SA

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2022
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2035

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: P.02.025.02

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No