N/A
Completed N=40
Medacta NextAR TKA Pivotal Trial
Source: ClinicalTrials.gov NCT04844879 ↗Enrolled (actual)
40
Serious AEs
30.0%
Results posted
Oct 2025
Primary outcomePrimary: Oxford Knee Score (OKS) — 39 scores on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxford Knee Score (OKS) |
41 | — |
| SECONDARY Oxford Knee Score (OKS) |
41 | — |
| SECONDARY Forgotten Joint Score (FJS) |
56.2; 60.4 | — |
| SECONDARY Objective Knee Society Score (KSS) |
87.0; 88.5 | — |
| SECONDARY Radiological Outcomes |
40; 0; 0; 0; 34; 3 | — |
| SECONDARY Surgical Outcome - Surgical Time |
3; 18; 13; 6 | — |
| SECONDARY Surgical Outcome - Necessity of Soft Tissue Release |
— | — |
| SECONDARY Surgical Outcome -Time to Discharge |
4.8 | — |
| SECONDARY Safety Outcomes |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04844879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.