{
    "info": {
        "nct_id": "NCT04650594",
        "official_title": "Clinical Results, Isokinetic Analysis and Radiologic Outcomes of Knee MUTARS Protheses Replacement for Malignant Tumours of Bone",
        "inclusion_criteria": "* Patient with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year,\n* Cardiological follow-up including at least one ECG and a clinical examination of less than 1 year (ability to perform the isokinetic test),\n* Written informed consent from patient,\n* Socially insured patient,\n* Patient willing to comply with all study procedures and study duration.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* - Underage,\n* Less than a one-year follow-up after surgery (stability of results is not achieved if follow-up is less than one year),\n* Meniscal lesion knee healthy side,\n* Prosthetic surgery of the knee healthy side,\n* Patient with an unbound fracture,\n* Patient without cardiological follow-up,\n* Pregnant or breastfeeding woman,\n* Inability to receive information, consent and participate in the whole study,\n* No social insurance cover,\n* No written consent,\n* Person under judicial protection or deprived of liberty.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year,",
            "criterions": [
                {
                    "exact_snippets": "MUTARS® modular reconstruction prostheses",
                    "criterion": "MUTARS® modular reconstruction prostheses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary or secondary knee bone malignancy",
                    "criterion": "knee bone malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "primary",
                                "secondary"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "minimal follow-up of one year",
                    "criterion": "follow-up duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiological follow-up including at least one ECG and a clinical examination of less than 1 year (ability to perform the isokinetic test),",
            "criterions": [
                {
                    "exact_snippets": "Cardiological follow-up including at least one ECG",
                    "criterion": "cardiological follow-up",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical examination of less than 1 year",
                    "criterion": "clinical examination",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ability to perform the isokinetic test",
                    "criterion": "ability to perform the isokinetic test",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent from patient,",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent from patient",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Socially insured patient,",
            "criterions": [
                {
                    "exact_snippets": "Socially insured patient",
                    "criterion": "social insurance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "insured"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient willing to comply with all study procedures and study duration.",
            "criterions": [
                {
                    "exact_snippets": "Patient willing to comply with all study procedures",
                    "criterion": "willingness to comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient willing to comply with ... study duration",
                    "criterion": "willingness to comply with study duration",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* - Underage,",
            "criterions": [
                {
                    "exact_snippets": "Underage",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": "underage"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than a one-year follow-up after surgery (stability of results is not achieved if follow-up is less than one year),",
            "criterions": [
                {
                    "exact_snippets": "Less than a one-year follow-up after surgery",
                    "criterion": "follow-up duration after surgery",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Meniscal lesion knee healthy side,",
            "criterions": [
                {
                    "exact_snippets": "Meniscal lesion knee healthy side",
                    "criterion": "meniscal lesion",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "knee healthy side"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prosthetic surgery of the knee healthy side,",
            "criterions": [
                {
                    "exact_snippets": "Prosthetic surgery of the knee",
                    "criterion": "prosthetic surgery",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "knee"
                        }
                    ]
                },
                {
                    "exact_snippets": "healthy side",
                    "criterion": "knee health",
                    "requirements": [
                        {
                            "requirement_type": "health status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with an unbound fracture,",
            "criterions": [
                {
                    "exact_snippets": "unbound fracture",
                    "criterion": "fracture",
                    "requirements": [
                        {
                            "requirement_type": "bound status",
                            "expected_value": "unbound"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient without cardiological follow-up,",
            "criterions": [
                {
                    "exact_snippets": "Patient without cardiological follow-up",
                    "criterion": "cardiological follow-up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breastfeeding woman,",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to receive information, consent and participate in the whole study,",
            "criterions": [
                {
                    "exact_snippets": "Inability to receive information, consent and participate in the whole study",
                    "criterion": "ability to receive information, consent and participate in the study",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No social insurance cover,",
            "criterions": [
                {
                    "exact_snippets": "No social insurance cover",
                    "criterion": "social insurance cover",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No written consent,",
            "criterions": [
                {
                    "exact_snippets": "No written consent",
                    "criterion": "written consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Person under judicial protection or deprived of liberty.",
            "criterions": [
                {
                    "exact_snippets": "Person under judicial protection",
                    "criterion": "judicial protection status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under judicial protection"
                        }
                    ]
                },
                {
                    "exact_snippets": "deprived of liberty",
                    "criterion": "liberty status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "deprived of liberty"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}