All Polyethylene Tibia-VEGA Kiel

Rheumatoid Arthritis Clinical Trial

— APT-VEGA_KI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756702
• Other study ID #: AAG-O-H-1527
• Status: Completed
• Start date: March 2016
• Est. completion date: October 6, 2022

Study information

• Verified date: June 2023
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 6, 2022
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deformity of Knee Joint
• Degenerative Osteoarthritis
• Osteoarthritis
• Other Instability, Knee
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis
• Stiffness of Knee, Not Elsewhere Classified

Intervention

Device:
• All-Poly
Implantation of the VEGA PS using all-polyethylene tibia components

Locations

Country	Name	City	State
Germany	MEDBALTIC GmbH c/o Mare Klinikum	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	Frictionless GmbH, Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complication/Adverse Event rate	Cumulative Number of Complications / Adverse Events of any reason over the period of follow-up	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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