Status:
COMPLETED
Medacta NextAR TKA Pivotal Trial
Lead Sponsor:
Medacta International SA
Conditions:
Musculoskeletal Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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).
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 me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04844879
Start Date
May 17 2021
End Date
June 18 2024
Last Update
October 14 2025
Active Locations (4)
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1
Privatklinik Belair
Schaffhausen, Switzerland, 8200
2
Privatklinik Lindberg
Winterthur, Switzerland, 8400
3
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
4
Uniklinik Balgrist
Zurich, Switzerland, 8008