All Polyethylene Tibia-VEGA Kiel (APT-VEGA_KI)

Prospective Observational 5 Year Follow-up on a Consecutive Cohort of 70 Primary Total Knee Arthroplasty (TKA) Cases Treated With All-polyethylene Tibia (APT) Components of the Posterior-stabilized VEGA System PS

Obligatory 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 will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b).

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Post-traumatic; Arthrosis; Degenerative Osteoarthritis; Other Instability, Knee; Stiffness of Knee, Not Elsewhere Classified; Deformity of Knee Joint
• Intervention / Treatment: Device: All-Poly

Detailed Description

This non-interventional clinical study (NIS) is conducted to clinically confirm the safety and performance of the Aesculap® APT 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 PE for TKA in general and for APT components in particular; thus a NIS is thought to be sufficient to give the required confirmation. For this NIS only CE-marked medical devices will be used within their intended purpose and no additional invasive or other stressful examinations are to be carried out (acc. to MPG §23b). As part of the post marketing surveillance plan an obligatory Post-Marketing Clinical Follow-up (PMCF) is required for the product under investigation.

• Study Type: Observational
• Enrollment (Actual): 70

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

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

Inclusion Criteria:

• Patients requiring primary TKA because of severe knee joint conditions that cannot be treated through other therapies;
• degenerative osteoarthritis;
• rheumatoid arthritis;
• posttraumatic arthritis;
• symptomatic knee instability;
• knee stiffness or deformation of the knee joint;
• Age ≥ 18 years;
• Patient signed informed consent

Exclusion Criteria:

• Age younger than 18 years
• Any prior joint replacement at the index knee
• Unable or unwilling to return for postoperative follow-up
• Patient did not sign informed consent
• Joint conditions that can be treated by reconstructive surgery (e.g. osteotomy)
• Acute or chronic infections near the joint, or systemic infections
• Secondary diseases that could influence joint implant functionality
• Systemic diseases and metabolic disorders
• Severe osteoporosis or osteomalacia
• Severely damaged bone structures that could prevent stable implantation of implant components
• Bone tumors in the region of implant fixation
• Bone malformations, axial misalignments or other bone conditions that rule out implantation of a prosthetic joint
• Expected overload on the joint implant, especially due to high patient weight or intense physical strain and activity
• Dependency on pharmaceutical drugs, drug abuse, or alcoholism
• Fever, infection or inflammation (systemic or local)
• Pregnancy
• Mental illness
• Severe osteopenia (or any other medical or surgical finding) that would preclude any benefit from the implants
• Combination with implant components from other manufacturers
• Inadequate patient compliance
• Foreign body sensitivity to the implant materials
• All cases not listed under indications

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All-Poly; All-polyethylene tibia VEGA System® PS - A posterior stabilized total knee arthroplasty (TKA) system using solely all-polyethylene tibia components	Device: All-Poly; Implantation of the VEGA PS using all-polyethylene tibia components; Other Names: Total Knee Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision Rate	The objective of the study is to collect clinical midterm outcome information on the product under investigation when used in routine clinical practice.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS (Knee Osteoarthritis Outcome Score)	Changes of the total Knee injury and Osteoarthritis Outcome Score (KOOS) from the preoperative baseline to the 5-year postoperative	5 years
KSS (Knee Society Score)	Changes of the Knee Society Score (KSS) with its Knee and Functional Score (KS and FS) from the preoperative baseline to the 5-year postoperative assessment	5 years
SF-12® Health Survey (SF-12)	Changes of the total SF-12® Health Survey (SF-12) components Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) from the preoperative baseline to the 5-year postoperative assessment	5 years
Complication/Adverse Event rate	Cumulative Number of Complications / Adverse Events of any reason over the period of follow-up	5 years
Change of anterior knee pain over follow-up period	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): October 6, 2022

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimated): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: TKA; TKR; posterior stabilized; All-Poly
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: AAG-O-H-1527

Plan for Individual participant data (IPD)

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