| Methods |
Randomisation by: method not stated. |
| Participants |
One hospital, Rotterdam, Netherlands.
From April 1991 to January 1995
60 patients.
Characteristics of participants:
Mean age 84 (range 71 to 96)
Male: 8 (13.3%)
Loss to follow‐up: none reported.
Inclusions: displaced intracapsular femoral neck fracture (Garden III‐IV), aged over 70, diagnosis of 'senile dementia' before admission
Exclusions: not mentioned |
| Interventions |
1. Reduction and fixation with 3 AO/ASIF screws versus
2. Unipolar Thompson hemiarthroplasty (cemented, anterior approach) |
| Outcomes |
Follow‐up for 24 months
Mean 16.5 months.
OUTCOMES COLLECTED BY TRIAL
(a) Operative details:
Number days admission to surgery
Length of surgery
Operative blood loss
(b) Complications related to type of operation:
For internal fixation: adequacy of reduction
Early and later secondary displacement, non‐union
For both methods:
Re‐operations, deep sepsis, superficial infection, haematoma, dehiscence
(c) Postoperative complications: none
(d) Postoperative care outcomes:
(e) Anatomical restoration: none
(f) Final outcome measures
Mortality at 30 days, 4 and 12 months
Ability to walk independently at 4 and 12 months
Activities of daily living at 4 months
(g) Economic cost: none |
| Notes |
Study specifically for patients with senile dementia
Confidence intervals for continuous outcomes supplied by the trialists |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Not stated |
| Blinding (performance bias and detection bias)
Were the assessors of pain and function at follow‐up blinded to the treatment allocation |
High risk |
No mention of blinding of assessors of pain and function |
