Medacta NextAR TKA Pivotal Trial

NCT04844879 | Completed Results

• 1 other identifier: P02.022.02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Musculoskeletal Diseases

Keywords

total knee arthroplasty; surgical navigation; medially-stabilized TKA

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score (OKS)

  Oxford Knee Score (OKS) \[Range: 0-48; higher values indicate better outcomes\]

  6 months

Secondary Outcomes (8)

• Oxford Knee Score (OKS)

  12 months

• Forgotten Joint Score (FJS)

  6 months and 12 months

• Objective Knee Society Score (KSS)

  6 months and 12 months

• Radiological Outcomes

  2 months and 12 months

• Surgical Outcome - Surgical Time

  Intraoperative

Study Arms (1)

Single-arm

EXPERIMENTAL

Patients suitable to receive Medacta GMK® Sphere system for primary TKA will be invited to take part to the study during the preoperative visit. Follow-ups are performed after 2, 6 and 12 months. Data collection includes clinical and radiological data for preoperative and postoperative assessments, as well as intraoperative details.

Device: NextAR TKA system

Interventions

NextAR TKA system DEVICE

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

Single-arm

Eligibility Criteria

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

You may qualify if:

• Males and females aged over 18 years at time of surgery.
• Patients who are scheduled to receive Medacta GMK® Sphere system for primary TKA (class III, CE-marked).
• Patients with functional contralateral knee (i.e. without the need to use walking aids).
• Patients willing and able to provide written informed consent for participation.
• 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 defined by the labelling on any Medacta implants used in this study:
• Patients presenting with progressive local or systemic infection
• Muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable.
• Severe instability secondary to advanced destruction of condralar structures or loss of integrity of the medial or lateral ligament
• Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
• Patients affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity.
• Patients unable to understand and take action.
• Patients with known allergy to the materials used.
• Patients in which Medacta GMK® Sphere system is used in emergency interventions.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (4)

Privatklinik Belair

Schaffhausen, 8200, Switzerland

Location

Privatklinik Lindberg

Winterthur, 8400, Switzerland

Location

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

Uniklinik Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Results Point of Contact

• Title: Medical Affairs Department
• Organization: Medacta International SA

myclinicaldata@medacta.ch

+41 91 696 60 60

Study Officials

• Sandro Fucentese, Prof. Dr. med.

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 14, 2021
• Study Start: May 17, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 18, 2024
• Last Updated: March 2, 2026
• Results First Posted: October 14, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)