Number of studies | ||||
---|---|---|---|---|

Assessment Item | Yes | No | Unable to judge | Not applicable |

Clarity of study question and definition of outcome
| ||||

Is the purpose of the study clearly stated? | 8 | 1 | 1 | - |

Is the definition of prosthesis failure clear? | 7 | 2 | - | 1 |

Is there a clear definition of primary outcome(s)? | 7 | 3 | - | - |

Are standardised outcome measures used? | 9 | - | 1 | - |

Are the outcome measures used appropriate for the purpose of the study? | 9 | 1 | - | - |

Description of prosthesis and method of fixation
| ||||

Is the prosthesis design adequately described? | 7 | 2 | - | 1 |

Is the method of fixation adequately described? | 7 | 2 | - | 1 |

Description of study sample
| ||||

Is the method of selection of the sample adequately described? | 2 | 7 | 1 | - |

Are the study exclusion and inclusion criteria stated? | 2 | 7 | 1 | - |

Is the baseline sample clearly described in terms of basic characteristics (age, sex etc)? | 6 | 3 | 1 | - |

Is the study sample sufficiently homogenous in terms of disease/diagnosis? | 5 | 1 | 4 | - |

Is the study sample sufficiently homogenous in terms of co-morbidity? | 2 | - | 8 | - |

Control of bias in study design
| ||||

Is the method of randomisation adequate? | - | - | 1 | 9 |

Is the method of masking the patient to the intervention allocated stated? | - | 2 | 1 | 7 |

Were outcome assessors blind to intervention allocation? | - | 1 | 3 | 6 |

Are baseline values for groups compared? | - | 1 | 1 | 8 |

Has the study adequately controlled for confounding factors? | 1 | 7 | 2 | - |

Duration and completeness of follow-up
| ||||

Are intervals between surgery and follow-up assessment clearly stated? | 8 | 2 | - | - |

Are reasons for loss of patients at follow-up stated? | 2 | 2 | 2 | 4 |

Are those lost to follow-up compared to the rest of the sample? | 1 | 2 | 3 | 4 |

Is there an appropriate length of follow-up? | 8 | 2 | - | - |

Is the length of follow-up at least 5 years? | 3 | 7 | - | - |

Statistical and analytical considerations
| ||||

Has the study sample size been justified? | - | 9 | 1 | - |

Are the data clearly presented? | 8 | 2 | - | - |

Was the data analyst masked to interventions? | - | 5 | 3 | 2 |

Has type of statistical test and actual probability value been stated? | 2 | 1 | 1 | 6 |

Are statistical tests appropriate to study? | 2 | - | 2 | 6 |

Is the sample on which failures are assessed adequate? | - | 2 | 7 | 1 |

Are conclusions justified by evidence? | 5 | 1 | 3 | 1 |