Methods |
Randomisation by: computer telephone randomisation service. |
Participants |
11 hospitals in Scotland, UK
298 patients
Characteristics of participants:
Mean age: 75 years
Male: 66 (22%)
Loss to follow‐up: 2 (0.7%)
Inclusions: mobile, mental test score equal to or more than 7/10, aged 60 and above, no serious concomitant disease, displaced intracapsular fracture
Exclusions: those not satisfying the above criteria |
Interventions |
1. Reduction and fixation with cancellous screws or sliding hip screw
versus:
2. Cemented bipolar hemiarthroplasty versus
3. Cemented total hip replacement (surgical approach for arthroplasty was that preferred by the surgeon) |
Outcomes |
Follow‐up for 24 months
OUTCOMES COLLECTED BY TRIAL
(a) Operative details: length of surgery in minutes, number transfused
(b) Complications related to type of operation:
For internal fixation: fixation failure, early redisplacement, non‐union, avascular necrosis
For replacement arthroplasty: dislocation
Re‐operations
Wound healing: superficial infection, deep sepsis
(c) Postoperative complications:
Deep vein thrombosis
Pulmonary embolism
Cerebrovascular accident
Septicaemia
Other medical complications
(d) Postoperative care outcomes: none
(e) Anatomical restoration: none
(f) Final outcome measures:
Mortality at 4, 12, 24 months
Pain at 4, 12, 24 months
Walking score at 4, 12, 24 months
Function score at 4, 12, 24 months
EQ5D score at 4, 12, 24 months
(g) Economic cost:
estimated cost for the three trial procedures |
Notes |
Additional information supplied by trialists |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
'centralized fully automated computer‐based telephone service' |
Allocation concealment (selection bias) |
Low risk |
'centralized fully automated computer‐based telephone service' |
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 |