VEGA Prospective Kiel

Aesculap

Status: Completed

Conditions: Degenerative Osteoarthritis; Rheumatoid Arthritis

Treatments: Device: VEGA Knee

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02802085

AAG-I-H-1319

Details and patient eligibility

About

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).

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

84 participants in 1 patient group

Knee Arthroplasty

Description:

Vega Knee Arthroplasty

Treatment:

Device: VEGA Knee