| Methods |
Randomisation by: date of birth. |
| Participants |
One hospital, Bergen, Norway.
From 1 October 1974 to 30 September 1976
104 patients
Characteristics of participants:
Mean age: fixation 77.9 , arthroplasty 78.3 years.
Male: 21 (20%)
Loss to follow‐up: 7 (6.7%)
Inclusions: acute femoral neck fracture (Garden II‐IV), aged over 67
Exclusions: by implication pathological fractures, metastatic carcinoma |
| Interventions |
‐Reduction and fixation with von Bahr screws versus
‐Bipolar hemiarthroplasty, Christiansen |
| Outcomes |
Follow‐up for 12 months
Mean: fixation 14.7 months, arthroplasty 14.5 months
OUTCOMES COLLECTED BY TRIAL
(a) Operative details:
Length of surgery
Transfusion
(b) Complications related to type of operation:
For internal fixation: mechanical failure, necrosis of femoral head
For replacement arthroplasty: postoperative luxation, delerin luxation
For both methods: re‐operation, superficial infection, haematoma
(c) Postoperative complications:
Deep vein thrombosis and Pulmonary embolism combined
Cardiopulmonary
Neurological
Drug exanthema
Urinary retention
(d) Postoperative care outcomes
Length of necessary hospital stay
Days to mobilisation
(e) Anatomical restoration:
Range of movement
(f) Final outcome measures:
Mortality at 1, 6, 12 months
Walking ability and aids used
Stitchfield's hip assessment (pain, movement, capacity for walking)
(g) Economic cost:
Includes initial stay and stay inclusive of re‐operations |
| Notes |
Fractures include Garden II‐IV.
Discrepancy in numbers originally randomised 121 or 123. 17 excluded after randomisation. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
'randomized into two groups according to their date of birth' |
| Allocation concealment (selection bias) |
High risk |
'randomized into two groups according to their date of birth' |
| 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 |
