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Completed

NCT Number: NCT02802085

VEGA Prospective Kiel

Voluntary Post-Marketing Clinical Follow-up (PMCF) as part of the post marketing surveillance plan for the product under investigation.

For this PMCF only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been or are to be carried out (acc. to MPG §23b).

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Key information

About this study

This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® VEGA System® PS components under routine conditions. The VEGA System® PS is an established TKA design, and there is a long-lasting experience in the use of PS components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices have been used and will be used within their intended purpose and no additional invasive or other stressful examinations have been and are to be carried out (acc. to MPG §23b). This voluntary NIS is part of the post-marketing surveillance for the product under investigation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has received primary TKA at the study site five to six years ago using the product under investigation because of the following severe knee joint conditions that could not be treated through other therapies:
  • degenerative osteoarthritis,
  • rheumatoid arthritis,
  • posttraumatic arthritis,
  • symptomatic knee instability, knee stiffness or deformation of the knee joint
  • Age at the time of surgery ≥ 18 years
  • Patient signed informed consent

Exclusion criteria

  • Age younger than 18 years at the time of surgery
  • Any prior joint replacement at the index knee
  • Patient did not sign informed consent
  • All cases not listed under indications (according to IfU)
  • All cases showing any contraindication (according to IfU)

Treatment and study plan

VEGA Knee

Device

TKA

Primary outcomes

  1. Revision (non-survival) rate

    Time frame: 5 years

    The objective of the study is to collect clinical 5 year outcome information on the product under investigation when used in routine clinical practice.

Secondary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 5 years

    Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5 year postoperative assessment

  2. Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)

    Time frame: 5 years

    Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment

  3. Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)

    Time frame: 5 years

    Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment

  4. Pain

    Time frame: 5 years

    Changes of anterior knee pain according to the Waters and Bentley rating system from the preoperative baseline to the 5 year postoperative assessment

  5. Knee Score (KS) of Knee Society Score (KSS)

    Time frame: 5 years

    The Knee Score (KS) of the Knee Society Score (KSS) at the 5 year postoperative assessment

  6. Functional Score (FS) of Knee Society Score (KSS)

    Time frame: 5 years

    The Functional Score (FS) of the Knee Society Score (KSS) at the 5 year postoperative assessment

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • Frictionless GmbH

Registry information

Official study title

A Prospective Observational 5 Year Follow-up on a Historical Consecutive Cohort of 100 Primary Total Knee Arthroplasty (TKA) Cases Treated With the Posterior-stabilized VEGA System® PS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2016
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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