Clinical trial NCT02802085: VEGA Prospective Kiel
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Osteoarthritis
Rheumatoid Arthritis
Keywords: Total Knee Arthroplasty
Total Knee Replacement
TKA
TKR
Stiffness of Knee
Deformity
Knee Joint
Instability
Post-traumatic
Arthrosis
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: Frictionless GmbH
First posted: 2016-06-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: 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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Revision (non-survival) rate
timeFrame: 5 years
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 5 years
measure: Physical Component Summary (PCS-12) of SF-12® Health Survey (SF-12)
timeFrame: 5 years
measure: Mental Component Summary (MCS-12) of SF-12® Health Survey (SF-12)
timeFrame: 5 years
measure: Pain
timeFrame: 5 years
measure: Knee Score (KS) of Knee Society Score (KSS)
timeFrame: 5 years
measure: Functional Score (FS) of Knee Society Score (KSS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: MEDBALTIC GmbH c/o Mare Klinikum
Study officials:
affiliation: orthopedics
name: Ludger Gerdesmeyer, Professor
role: PRINCIPAL_INVESTIGATOR
References: