CompletedNot Applicable

VEGA Prospective Kiel

Germany84 participantsStarted 2016-05

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Revision (non-survival) rate

Timeframe: 5 years

Trial details

NCT IDNCT02802085

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-02

View on ClinicalTrials.gov More Degenerative Osteoarthritis trials