MOTO Post-marketing Surveillance Study

NCT04072055 | Terminated FDA Device

• 1 other identifier: P02.021.01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Osteonecrosis; Osteo Arthritis Knee

Keywords

Unicompartmental Knee Arthroplasty; UKA; antomic femoral component; anatomic tibial component

Outcome Measures

Primary Outcomes (1)

• Prosthesis survival

  survivorship analysis according to Kaplan-Meier method at 5 years after surgery

  5 years

Secondary Outcomes (3)

• New Knee Society Score (KSS)

  preoperative, 3 months, 1, 3 and 5 years

• Radiological analysis

  preoperative, postoperative, 3 months, 1, 3 and 5 years

• Complication

  up to 5 years

Study Arms (1)

MOTO medial

Patients suitable fulfilling the standard criteria for the implantation of unicondylar implant.

Device: MOTO Medial

Interventions

MOTO Medial DEVICE

MOTO medial unicompartmental knee system

MOTO medial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 patients

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (2)

AZ Zeno Campus Knokke-Heist

Knokke-Heist, 8300, Belgium

Location

Clinique Saint-Joseph

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: September 25, 2019
• Primary Completion: March 16, 2023
• Study Completion: March 16, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

BE (2)