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Medacta NextAR TKA Pivotal Trial

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ClinicalTrials.gov Identifier: NCT04844879
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Medacta International SA

Study Description
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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).

Condition or disease Intervention/treatment Phase
Musculoskeletal Diseases Device: NextAR TKA system Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 17, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single-arm
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Functional outcome [ Time Frame: 6 months ]
    Oxford Knee Score (OKS)


Secondary Outcome Measures :
  1. Functional outcome [ Time Frame: 12 months ]
    Oxford Knee Score (OKS)

  2. Functional outcome [ Time Frame: 6 months and 12 months ]
    Forgotten Joint Score (FJS)

  3. Clinical and functional outcome [ Time Frame: 6 months and 12 months ]
    Knee Society Score (KSS)

  4. Radiological outcomes [ Time Frame: 2 months and 12 months ]
    Radiological assessment including implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis

  5. Surgical outcome [ Time Frame: Intraoperative ]
    Surgical time (min)

  6. Surgical outcome [ Time Frame: Intraoperative ]
    Necessity of soft tissue release to obtain ligament or patellar balance (Y/N)

  7. Surgical outcome [ Time Frame: Immediate postoperative ]
    Time to discharge (days)

  8. Safety outcomes [ Time Frame: Intraoperative, 2 months, 6 months and 12 months ]
    Device deficiencies and adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844879


Contacts
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Contact: Denise Falcone, PhD +41916966060 falcone@medacta.ch

Locations
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Switzerland
Privatklinik Belair Recruiting
Schaffhausen, Switzerland, 8200
Contact: Peter Koch, Dr. med.         
Privatklinik Lindberg Recruiting
Winterthur, Switzerland, 8400
Contact: Peter Koch, Dr. med.         
Kantonsspital Winterthur Active, not recruiting
Winterthur, Switzerland, 8401
Uniklinik Balgrist Recruiting
Zurich, Switzerland, 8008
Contact: Sandro Fucentese, Prof. Dr. med.         
Sponsors and Collaborators
Medacta International SA
Investigators
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Principal Investigator: Sandro Fucentese, Prof. Dr. med. Balgrist University Hospital
More Information
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Responsible Party: Medacta International SA
ClinicalTrials.gov Identifier: NCT04844879    
Other Study ID Numbers: P02.022.02
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Medacta International SA:
total knee arthroplasty
surgical navigation
medially-stabilized TKA
Additional relevant MeSH terms:
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Musculoskeletal Diseases