Clinical trial NCT04844879: Medacta NextAR TKA Pivotal Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: total knee arthroplasty
surgical navigation
medially-stabilized TKA
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Males and females aged over 18 years at time of surgery.
2. Patients who are scheduled to receive Medacta GMK® Sphere system for primary TKA (class III, CE-marked).
3. Patients with functional contralateral knee (i.e. without the need to use walking aids).
4. Patients willing and able to provide written informed consent for participation.
5. Patients willing to comply with the pre and post-operative evaluation schedule.

Exclusion Criteria:

1. 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
2. Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
3. Patients affected by concomitant spine, hip, ankle or contralateral knee pathologies that can affect walking capacity.
4. Patients unable to understand and take action.
5. Patients with known allergy to the materials used.
6. Patients in which Medacta GMK® Sphere system is used in emergency interventions.

Primary outcomes:
measure: Functional outcome
timeFrame: 6 months
Secondary outcomes:
measure: Functional outcome
timeFrame: 12 months
measure: Functional outcome
timeFrame: 6 months and 12 months
measure: Clinical and functional outcome
timeFrame: 6 months and 12 months
measure: Radiological outcomes
timeFrame: 2 months and 12 months
measure: Surgical outcome - Surgical time
timeFrame: Intraoperative
measure: Surgical outcome - Necessity of soft tissue release
timeFrame: Intraoperative
measure: Surgical outcome -Time to discharge
timeFrame: 2 months
measure: Safety outcomes
timeFrame: Intraoperative, 2 months, 6 months and 12 months
Other outcomes:
Locations:
city: Schaffhausen
country: Switzerland
facility: Privatklinik Belair
city: Winterthur
country: Switzerland
facility: Privatklinik Lindberg
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: Uniklinik Balgrist
Study officials:
affiliation: Balgrist University Hospital
name: Sandro Fucentese, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: