All Polyethylene Tibia-VEGA Kiel

NCT ID: NCT02756702

Last Updated: 2023-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2022-10-06

Brief 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).

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All-Poly

All-polyethylene tibia VEGA System® PS - A posterior stabilized total knee arthroplasty (TKA) system using solely all-polyethylene tibia components

All-Poly

Intervention Type: DEVICE

Implantation of the VEGA PS using all-polyethylene tibia components

Interventions

All-Poly

Implantation of the VEGA PS using all-polyethylene tibia components

Intervention Type: DEVICE

Other Intervention Names

Total Knee Replacement

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frictionless GmbH, Kiel

UNKNOWN

Sponsor Role: collaborator

Aesculap AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ludger Gerdesmeyer, Professor

Role: PRINCIPAL_INVESTIGATOR

orthopedics

Locations

MEDBALTIC GmbH c/o Mare Klinikum

Kiel, , Germany

Countries

Germany

Other Identifiers

AAG-O-H-1527

Identifier Type: -

Identifier Source: org_study_id