VEGA Prospective Kiel

NCT02802085 | Completed

• 1 other identifier: AAG-I-H-1319
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Degenerative Osteoarthritis; Rheumatoid Arthritis

Keywords

Total Knee Arthroplasty; Total Knee Replacement; TKA; TKR; Stiffness of Knee; Deformity; Knee Joint; Instability; Post-traumatic; Arthrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  5 years

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

  5 years

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

  5 years

• Pain

  5 years

• Knee Score (KS) of Knee Society Score (KSS)

  5 years

Study Arms (1)

Knee Arthroplasty

Vega Knee Arthroplasty

Device: VEGA Knee

Interventions

VEGA Knee DEVICE

TKA

Knee Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult patients

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aesculap AG: lead
• Frictionless GmbH: collaborator

Study Sites (1)

MEDBALTIC GmbH c/o Mare Klinikum

Kiel, 24119, Germany

Location

Related Publications (1)

• Gerdesmeyer L, Glowalla C, Lasic I, Al Muderis M, Weuster M, Klueter T. The Vega advanced third generation posterior stabilized total knee arthroplasty system enables the restoration of range of motion for high demanding daily activities - A 5-years follow-up study. PLoS One. 2024 May 13;19(5):e0302885. doi: 10.1371/journal.pone.0302885. eCollection 2024.

  PMID: 38739584 DERIVED

MeSH Terms

Conditions

Joint Diseases; Arthritis, Rheumatoid; Congenital Abnormalities; Osteoarthritis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ludger Gerdesmeyer, Professor

  orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 16, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)