Rheumatoid Arthritis Clinical Trial
— APT-VEGA_KIOfficial 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
NCT number | NCT02756702 |
Other study ID # | AAG-O-H-1527 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | October 6, 2022 |
Verified date | June 2023 |
Source | Aesculap AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Germany | MEDBALTIC GmbH c/o Mare Klinikum | Kiel |
Lead Sponsor | Collaborator |
---|---|
Aesculap AG | Frictionless GmbH, Kiel |
Germany,
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 |
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