| Methods |
Randomisation by: sealed envelopes. |
| Participants |
one centre, Tampere, Finland
From February 1994
31 patients
Characteristics of participants:
Mean age 81 yr fixation, 82 years arthroplasty (range 77 to 90)
5 (16%) male
Loss to follow‐up: none
Inclusions: femoral neck fracture, Garden 3‐4; aged > 75 years
Exclusions: unable to walk independently (without other person's help), rheumatoid arthritis |
| Interventions |
1. Reduction and fixation with 3 Ulleval screws versus
2. Cemented Thompson unipolar hemiarthroplasty (posterior approach) |
| Outcomes |
Follow‐up for 2 years at 6 weeks, 3, 12, 24 months
OUTCOMES COLLECTED BY TRIAL
(a) Operative details
Mean length of surgery in minutes
Mean operative blood loss in ml
(b) Complications related to type of operation
Internal fixation/pseudarthrosis, osteonecrosis, failed osteosynthesis
Replacement arthroplasty/evaluation of stem position and cementing
For both methods:
Re‐operation, wound infection
(c) Postoperative complications
Immediate systemic complications
(d) Postoperative care outcomes: none
(e) Anatomical restoration: none
(f) Final outcome measures
Mortality 3 and 24 months
(g) Economic cost |
| Notes |
Study terminated early due to high complication rate in fixation group. One patient randomised to receive internal fixation was excluded from the study as acceptable reduction of the fracture could not be achieved and this patient was treated with an arthroplasty. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
not stated |
| Allocation concealment (selection bias) |
Unclear risk |
'sealed 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 |
