| Methods |
Randomisation by: computer generation of random numbers. |
| Participants |
General hospital, Leicester, UK.
From 1 January 1991 to 31 January 1996
280 patients.
Characteristics of participants: Median age: in each group 73, 76, 75 (range 69 to 79).
Male: 67 (24%)
Loss to follow‐up: 50 (17.9%)
Inclusions: Displaced intracapsular fracture of the proximal femur, Aged 65 to 79
Exclusions: Abbreviated mental test score < 5/13, uncontrolled Parkinson's disease, pathological fracture, disseminated malignancy, Paget's disease, rheumatoid arthritis, long‐term steroids |
| Interventions |
1. Reduction and fixation with 'Ambi' compression hip screw (AHS) and 2 hole plate versus:
2. Cemented Thompson unipolar hemiarthroplasty (Hardinge approach) versus
3. Cemented Monk bipolar hemiarthroplasty (Hardinge approach) |
| Outcomes |
Follow‐up for 5 years at 6/52, 1/12, 24/12, 36/12, 48/12, 60/12. Actual minimum 2 years
OUTCOMES COLLECTED BY TRIAL
(a) Operative details: none
(b) Complications related to type of operation:
For internal fixation: non‐union, migration and cut‐out of screw, avascular necrosis and collapse, degeneration of joint
For replacement arthroplasty: acetabular erosion, loosening and subsidence
(c) Postoperative complications: none
(d) Postoperative care outcomes: none
(e) Anatomical restoration: none
(f) Final outcome measures:
Mortality at 6, 12, 18, 24, 30, 36 months and time to death
Time to revision
Harris hip score
Subjective function and satisfaction
Functional outcome from home assessment Barthel index (for activities of daily living)
Time to preinjury state and satisfaction with outcome
(g) Economic cost: none |
| Notes |
Discrepancy with abstract 1997 which mentions 282 patients. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
'computer generation of random numbers' |
| Allocation concealment (selection bias) |
Unclear risk |
'computer generation of random numbers' |
| Blinding (performance bias and detection bias)
Were the assessors of pain and function at follow‐up blinded to the treatment allocation |
Low risk |
Home assessment of patients by observer blinded to type of operative treatment |
