Osteo Arthritis Knee Clinical Trial
Official title:
MOTO MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY: OPEN, PROSPECTIVE, MULTICENTRIC, OBSERVATIONAL STUDY
Verified date | March 2023 |
Source | Medacta International SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The prospective, multicentric, observational study has the aims to monitor the performance of the MOTO medial unicompartmental knee system in the treatment of patients with knee disease requiring a UKA. 150 patients will be recruited in 18 months and will be reviewed until 5 years follow-up visit after surgery. The primary objective of the study is to evaluate the prosthesis survival at 5 years.
Status | Terminated |
Enrollment | 150 |
Est. completion date | March 16, 2023 |
Est. primary completion date | March 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with unicompartmental tibiofemoral osteoarthritis (OA) of the knee that meet the indications for use of Medacta implant included in this study (on-label use); - Patients suffering from unilateral osteoarthritis or osteonecrosis of a single knee compartment; - Frontal deformity < 10° (evaluated on weight-bearing long-axis x-rays); - Flexion contracture < 10°; - Intact ligaments; - Patients willing and able to provide written informed consent for participation in the study; - Patient's age over 18 years old; - Patient with BMI < 40 kg/m2; - Patients willing to comply with the pre and post-operative evaluation schedule. Exclusion Criteria: - Patients with one or more medical conditions identified as a contraindication in the labelling on any Medacta implants used in this study; - Any patient who cannot or will not provide informed consent for participation in the study; - Patients who need a revision surgery; - Patients who had previously undergone high tibial osteotomy or anterior cruciate ligament (ACL) reconstruction; - Patients with BMI = 40 kg/m2; - Patients unable to understand and take action; - Any case not described in the inclusion criteria. |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Zeno Campus Knokke-Heist | Knokke-Heist | |
Belgium | Clinique Saint-Joseph | Liège |
Lead Sponsor | Collaborator |
---|---|
Medacta International SA |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prosthesis survival | survivorship analysis according to Kaplan-Meier method at 5 years after surgery | 5 years | |
Secondary | New Knee Society Score (KSS) | Functionality and symptom of operated knee will be evaluated by New KSS score | preoperative, 3 months, 1, 3 and 5 years | |
Secondary | Radiological analysis | Postoperative stability and fixation of the device will be assessed by standard radiological exams | preoperative, postoperative, 3 months, 1, 3 and 5 years | |
Secondary | Complication | Intraoperative and postoperative complication will be collected during all duration of the study | up to 5 years |
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