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 |