Medacta NextAR TKA Pivotal Trial

Musculoskeletal Diseases Clinical 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04844879
• Other study ID #: P02.022.02
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Medacta International SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases

Intervention

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

Locations

Country	Name	City	State
Switzerland	Privatklinik Belair	Schaffhausen
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	Privatklinik Lindberg	Winterthur
Switzerland	Uniklinik Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	Oxford Knee Score (OKS)	6 months
Secondary	Functional outcome	Oxford Knee Score (OKS)	12 months
Secondary	Functional outcome	Forgotten Joint Score (FJS)	6 months and 12 months
Secondary	Clinical and functional outcome	Knee Society Score (KSS)	6 months and 12 months
Secondary	Radiological outcomes	Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis	2 months and 12 months
Secondary	Surgical outcome - Surgical time	Surgical time (min)	Intraoperative
Secondary	Surgical outcome - Necessity of soft tissue release	Necessity of soft tissue release to obtain ligament or patellar balance (Y/N)	Intraoperative
Secondary	Surgical outcome -Time to discharge	Time to discharge (days)	2 months
Secondary	Safety outcomes	Device deficiencies and adverse events	Intraoperative, 2 months, 6 months and 12 months