Medacta NextAR TKA Pivotal Trial

Musculoskeletal Diseases Clinical Trial

Official title: Prospective, Multicentre, Single-arm, Open, Confirmatory Trial to Assess Efficacy and Safety of a Navigation System Providing Personalized Soft Tissue Balance Data in Medially-stabilized Total Knee Arthroplasty

Status Active, not recruiting

Clinical Trial Summary

The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).

Clinical Trial Description

This is a prospective, multicentre, single-arm, open, confirmatory clinical investigation to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).

Participants will be informed about the study, both orally and in writing, during a preoperative visit. The investigator will answer any questions that may arise and will collect the informed consent. During the study, enrolled participants will be able to withdraw at any time and for any reason.

The study is conducted according to the following schedule:

• V1 : Inclusion during a preoperative visit

• V2: Surgery

• V3: Follow-up visit at 2 month post-surgery

• V4: Follow-up visit at 6 months post-surgery

• V5: Follow-up visit at 12 months post-surgery

The following data will be collected:

• Oxford Knee Score (OKS), Knee Society Score (KSS), Forgotten Joint Score (FJS) and patient satisfaction at 6 months and 12 months of follow-up;

• Radiological analysis at 2 and 12 months of follow-up;

• Surgical time (min);

• Necessity of soft tissue release to obtain ligament or patellar balance;

• Time to discharge (days);

• Device deficiencies and peri- and postoperative adverse events.

A web-based data collection tool will be used as Electronic Data Capture (EDC). All the information required by the protocol will be collected in electronic case report forms (eCRF).

The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis. ;

Related Conditions & MeSH terms

• Musculoskeletal Diseases

• NCT number: NCT04844879
• Study type: Interventional
• Source: Medacta International SA
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 17, 2021
• Completion date: June 30, 2024