The Medacta International GMK Sphere Cementless Post-Marketing Surveillance Study

N/AActive Not RecruitingNCT05003414

Medacta International SA200 enrolled

Overview

This is a Post-Marketing Surveillance study of GMK Sphere cementless knee prosthesis.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Arthritis Traumatic Arthritis Rheumatoid Arthritis Poly-arthritis Avascular Necrosis

Interventions

GMK Sphere cementless Knee ReplacementDEVICE

Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis * Patients between the age of 18 and 80 at the time of consent * Listed for total knee replacement surgery. * Patients who are willing and able to give informed written consent Exclusion Criteria: * Progressive local or systemic infection * Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable * Severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament * Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems * Patient whose BMI exceeds 40 * Any case not described in the inclusion criteria

Locations (5)

Clinique Saint Vincent de Paul

Bourgoin, France

Clinique du Parc

Caen, France

Hôpitaux Civils de Colmar

Colmar, France

Clinique des Acacias

Cucq, France

Hôpital de la Tour

Outcomes

Primary Outcomes

Survival rate

Kaplan Meier method

Time frame: 10 years

Secondary Outcomes

Clinical outcome: Knee Society score

Knee Society Score (KSS): evaluates pain, in a total of 50 points, stability, 25 points, and range of motion, 25 points. The maximum score of 100 points is reached when there is no pain, with good alignment of the knee in extension, and at least 125° of range of motion, without any anteroposterior or mediolateral instability.

Time frame: Preop and 1, 2, 5, 10 years postop

Patient-reported outcome: Forgotten Joint Score

Forgotten Joint Score (FJS) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment.It 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

Time frame: 1, 2, 5, 10 years postop

Radiographic performance of the implants looking for radiolucencies, migration, loosening, subsidence

Presence of radiolucencies, migration, loosening, subsidence

Time frame: Immediately postop + 1, 2, 5, 10 years postop

Intraoperative and postoperative Adverse events

Intraoperative and postoperative adverse events

Time frame: Intraop + Immediately postop + 1, 2, 5, 10 years postop

Data from ClinicalTrials.gov

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