| Methods |
Randomisation by: sealed, opaque numbered envelopes drawn sequentially. |
| Participants |
Multicentre: 12 centres in Sweden
From 1995 to 1997
409 patients
Characteristics of participants:
Mean age male, 80.7 years
Mean age female, 81.8 years
Male: 85 (21%)
Loss to follow‐up at 2 years: 41/450 were drop‐outs (10 planned surgery stopped due to medical reasons, 8 lost to follow‐up, 7 not meeting criteria, 13 withdrawals, 3 died before surgery). 409 included in analysis.
Inclusions: cervical hip fracture, graded 3‐4; independent, mentally alert
Exclusions: mentally confused, bedridden or institution dwelling, rheumatoid arthritis, fracture > 2 days |
| Interventions |
1. Reduction and fixation with Hansson hook‐pins or Olmed screws versus
2. Replacement arthroplasty, various types, choice of surgeon and included cemented and uncemented types. |
| Outcomes |
Follow‐up for 24 months
OUTCOMES COLLECTED BY TRIAL
(a) Operative details:
Time admission to surgery.
Length of surgery in minutes
(b) Complications related to type of operation
For internal fixation: non‐union or early redisplacement, avascular necrosis, pain.
For replacement arthroplasty: dislocation, diaphyseal fracture.
For both methods:
Re‐operation
Deep infection
Failure
(c) Postoperative complications: stroke, pulmonary or cardiac insufficiency, pressure sores, venous thromboembolic complication
(d) Postoperative care outcomes
Length of hospital stay.
(e) Anatomical restoration: None
(f) Final outcome measures:
Mortality, perioperative and at 4, 12 and 24 months
Functional outcome (walking ability and pain)
Pain
Mobility
(g) Economic cost: for a subgroup of 68 cases |
| Notes |
Twenty‐six patients did not attend 2 year control (failure status reported at 1 year)
Additional information supplied by the trialists
Cost information was reported in a paper in 2003 for a subgroup of 68 cases.
Subsequent report of this study with a long‐term follow‐up of included patients (Leonardsson 2010) presents the outcomes of mortality, surgical complications, re‐operations, hip pain and mobility. Mean follow up was 123/124 months with 4 patients lost to follow‐up.
The number of dislocations was reported as 15 in the original report but 12 in the later report with two of these dislocations occurring after the initial report was made. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
not clearly stated |
| Allocation concealment (selection bias) |
Low risk |
'sealed numbered opaque envelopes' |
| 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 |
