NCT04844879

Medacta NextAR TKA Pivotal Trial

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Musculoskeletal Diseases

Interventions

Type	Name	Description
DEVICE	NextAR TKA system	The NextAR TKA system is a surgical guidance system which measures intra-operatively the effect of prosthesis alignment and positioning on soft tissue balance.

Timeline

• Start date: 2021-05-17
• Primary completion: 2023-12-31
• Completion: 2024-06-18
• First posted: 2021-04-14
• Last updated: 2026-03-02
• Results posted: 2025-10-14

Locations

4 sites across 1 country: Switzerland