VEGA Prospective Kiel

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

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).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Degenerative Osteoarthritis
• Intervention / Treatment: Device: VEGA Knee

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany, 24119
    • MEDBALTIC GmbH c/o Mare Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee Arthroplasty; Vega Knee Arthroplasty	Device: VEGA Knee; TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision (non-survival) rate	The objective of the study is to collect clinical 5 year outcome information on the product under investigation when used in routine clinical practice.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS)	Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5 year postoperative assessment	5 years
Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)	Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment	5 years
Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)	Changes of the total SF-12® Health Survey (SF-12) from the preoperative baseline to the 5 year postoperative assessment	5 years
Pain	Changes of anterior knee pain according to the Waters and Bentley rating system from the preoperative baseline to the 5 year postoperative assessment	5 years
Knee Score (KS) of Knee Society Score (KSS)	The Knee Score (KS) of the Knee Society Score (KSS) at the 5 year postoperative assessment	5 years
Functional Score (FS) of Knee Society Score (KSS)	The Functional Score (FS) of the Knee Society Score (KSS) at the 5 year postoperative assessment	5 years

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: Frictionless GmbH
• Investigators: Principal Investigator: Ludger Gerdesmeyer, Professor, orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (Estimate): June 16, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Total Knee Replacement; Arthrosis; TKA; TKR; Knee Joint; Instability; Deformity; Post-traumatic; Stiffness of Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: AAG-I-H-1319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO