The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Recruiting

• Conditions: Knee Replacement; Arthropathy

• Registration Number: NCT05459948
• Lead Sponsor: Medacta International SA

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.

Study Timeline

• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-15
• Study Start: 2022-07-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2035-05
• Study Completion: 2035-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 281

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective will be evaluated with the Forgotten Joint score (FJS).	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 Outcome Measures

Name	Time	Method
Limb alignment	on preoperative and 6-week x-rays	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
Satisfaction and Expectations questionaires	6 weeks, from 1 to 10 years annually	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.
Lateral uncoverage of the anterior femoral resection	During Surgical Operation	Measurement of the lateral uncoverage of the anterior femoral resection measured in mm
Radiological outcomes	pre-op, 6weeks, 1, 2,5,10 years	Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis
patient-reported outcomes 1	6 weeks, from 1 to 10 years annually	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
Adverse events	during surgical operation, 6weeks, 1,2,5,10 years	Adverse events (type of complications, dependent or not from the device etc)

Trial Locations

Locations (4)

Humanitas Castelli; 🇮🇹 Bergamo, Italy

Centre de l'Arthrose; 🇫🇷 Mérignac, France

Clinique de l'Union; 🇫🇷 Saint-Jean, France

Gelenkzentrum Winterthur; 🇨🇭 Winterthur, Switzerland