NCT04844879

Medacta NextAR TKA Pivotal Trial

Completed NA Results posted Last updated 2 March 2026

What this trial tests

NA trial testing NextAR TKA system in Musculoskeletal Diseases in 40 participants. Completed in 18 June 2024.

Timeline

17 May 2021

Primary endpoint
31 December 2023

18 June 2024

Quick facts

Lead sponsor	Medacta International SA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	17 May 2021
Primary completion	31 December 2023
Estimated completion	18 June 2024
Sites	4 locations across Switzerland

Drugs / interventions tested

• NextAR TKA system

Conditions studied

• Musculoskeletal Diseases — all drugs for Musculoskeletal Diseases →

Sponsor

Medacta International SA — full company profile →

Who can join

18 and older, any sex, with Musculoskeletal Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Oxford Knee Score (OKS) Primary · 6 months

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

Group	Value	95% CI
NextAR TKA	39	33 – 43

Oxford Knee Score (OKS) Secondary · 12 months

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

Group	Value	95% CI
NextAR TKA	41	36 – 46

Forgotten Joint Score (FJS) Secondary · 6 months and 12 months

Forgotten Joint Score (FJS) \[Range: 0-100; higher values indicate better outcomes\]

6-month follow up

Group	Value	95% CI
NextAR TKA	56.2	30.2 – 78.1

12-month follow up

Group	Value	95% CI
NextAR TKA	60.4	45.8 – 91.7

Objective Knee Society Score (KSS) Secondary · 6 months and 12 months

Objective Knee Society Score (KSS) \[Range: 0-100; higher values indicate better outcomes; total score reported as the average of subscale scores\]

6-month follow up

Group	Value	95% CI
NextAR TKA	87.0	63.0 – 96.0

12-month follow up

Group	Value	95% CI
NextAR TKA	88.5	44.0 – 99.0

Radiological Outcomes Secondary · 2 months and 12 months

X-ray assessment for the evaluation of: implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis

2-month follow up

Group	Value	95% CI
NextAR TKA	40
NextAR TKA	0
NextAR TKA	0
NextAR TKA	0

12-month follow up

Group	Value	95% CI
NextAR TKA	34
NextAR TKA	3
NextAR TKA	0
NextAR TKA	0

Surgical Outcome - Surgical Time Secondary · Intraoperative

Surgical time (min)

Group	Value	95% CI
NextAR TKA	3
NextAR TKA	18
NextAR TKA	13
NextAR TKA	6

Surgical Outcome - Necessity of Soft Tissue Release Secondary · Intraoperative

Necessity of soft tissue release to obtain ligament or patellar balance (Y/N)

Group	Value	95% CI
NextAR TKA	0

Surgical Outcome -Time to Discharge Secondary · 2 months

Time to discharge (days)

Group	Value	95% CI
NextAR TKA	4.8	3 – 16

Adverse events — posted to ClinicalTrials.gov

Time frame: From signature of the informed consent up to 12 months postoperatively.. Reporting threshold: 2.5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NextAR TKA

Serious: 12/40 (30%)

Deaths: 1/40

Serious adverse events (12 terms)

Reaction	System	NextAR TKA
Venous thrombosis	Blood and lymphatic system disorders	—
Hemarthrosis	Musculoskeletal and connective tissue disorders	—
Arthritis flare	Musculoskeletal and connective tissue disorders	—
Accidental fall leading to TKA revision	Musculoskeletal and connective tissue disorders	—
Thrombosis main vein of the eye	Eye disorders	—
Accidental fall leading to wound opening and spine surgery	Musculoskeletal and connective tissue disorders	—
Death	General disorders	—
Transient deficit in range of motion	Musculoskeletal and connective tissue disorders	—
Carpal tunnel syndrome	Musculoskeletal and connective tissue disorders	—
Chronic dislocation of the patella	Musculoskeletal and connective tissue disorders	—
Benign paroxysmal positional vertigo	Ear and labyrinth disorders	—
Arthrosis contralateral knee	Musculoskeletal and connective tissue disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	NextAR TKA
Postoperative knee pain, inflammation, or swelling	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Venous thrombosis, Hemarthrosis, Arthritis flare, Accidental fall leading to TKA revision, Thrombosis main vein of the eye, Accidental fall leading to wound opening and spine surgery, Death, Transient deficit in range of motion.

Data from ClinicalTrials.gov NCT04844879 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Direct pulmonary delivery route in lung cancer: a highway for siRNA therapeutics.
   Sharif MS, Luzzi L, De Laurentiis M, Giordano A, et al · · 2025 · PMID 41658564 · DOI 10.3389/fonc.2025.1722906