## Protocol Section
### Identification Module
**NCT ID:** NCT04844879

**Brief Title:** 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

#### Organization Study ID Info
**ID:** P02.022.02
#### Organization
**Class:** INDUSTRY
**Full Name:** Medacta International SA
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-30

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-05-17

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2021-04-14
**Type:** ACTUAL
**Study First Submit Date:** 2021-04-08
**Study First Submit QC Date:** 2021-04-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Medacta International SA

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Musculoskeletal Diseases

**Keywords:**

- total knee arthroplasty

- surgical navigation

- medially-stabilized TKA

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: NextAR TKA system

**Label:** Single-arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Single-arm

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

**Name:** NextAR TKA system

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Oxford Knee Score (OKS)

**Measure:** Functional outcome

**Time Frame:** 6 months

#### Secondary Outcomes

**Description:** Oxford Knee Score (OKS)

**Measure:** Functional outcome

**Time Frame:** 12 months

**Description:** Forgotten Joint Score (FJS)

**Measure:** Functional outcome

**Time Frame:** 6 months and 12 months

**Description:** Knee Society Score (KSS)

**Measure:** Clinical and functional outcome

**Time Frame:** 6 months and 12 months

**Description:** Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis

**Measure:** Radiological outcomes

**Time Frame:** 2 months and 12 months

**Description:** Surgical time (min)

**Measure:** Surgical outcome - Surgical time

**Time Frame:** Intraoperative

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

**Measure:** Surgical outcome - Necessity of soft tissue release

**Time Frame:** Intraoperative

**Description:** Time to discharge (days)

**Measure:** Surgical outcome -Time to discharge

**Time Frame:** 2 months

**Description:** Device deficiencies and adverse events

**Measure:** Safety outcomes

**Time Frame:** Intraoperative, 2 months, 6 months and 12 months

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Schaffhausen

**Country:** Switzerland

**Facility:** Privatklinik Belair

**Zip:** 8200

**Location 2:**

**City:** Winterthur

**Country:** Switzerland

**Facility:** Privatklinik Lindberg

**Zip:** 8400

**Location 3:**

**City:** Winterthur

**Country:** Switzerland

**Facility:** Kantonsspital Winterthur

**Zip:** 8401

**Location 4:**

**City:** Zurich

**Country:** Switzerland

**Facility:** Uniklinik Balgrist

**Zip:** 8008

#### Overall Officials

**Official 1:**

**Affiliation:** Balgrist University Hospital

**Name:** Sandro Fucentese, Prof. Dr. med.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: HIGH

- As Found: Musculoskeletal Diseases

### Condition Browse Module - Meshes

- ID: D000009140

- Term: Musculoskeletal Diseases

### Misc Info Module

- Version Holder: 2024-05-24
