| Methods |
Randomisation by: sealed envelopes. |
| Participants |
One hospital, Karolinska Institute at Stockholm Söder Hospital, Sweden.
102 patients. (8 further patients were randomised but excluded: Six in the arthroplasty group were excluded as two patients had aortic valve stenosis, one patient had urinary tract infection, two patients changed their mind, and one had rheumatoid arthritis. For the internal fixation group, one had rheumatoid arthritis and one changed their mind)
Characteristics of participants:
Mean age: 79/81 years (range 70 to 96)
Male: 20 (20%)
Loss to follow‐up: 3 (3%)
Inclusions: age 70 years and above, short portable mental status questionnaire of more than 2/10, displaced fracture of the femoral neck, not living in an institution, able to walk independently or with aids
Exclusions: pathological fractures, fracture more than 24 hours from occurrence, rheumatoid arthritis, osteoarthritis |
| Interventions |
1. Reduction and fixation with two cannulated screws versus
2. Exeter's modular stem cemented total hip replacement via an anterolateral approach |
| Outcomes |
Follow‐up for 48 months
OUTCOMES COLLECTED BY TRIAL
(a) Operative details: length of surgery in minutes, operative blood loss, number of patients transfused
(b) Complications related to type of operation:
For internal fixation: fixation failure, early redisplacement, non‐union, avascular necrosis, fracture around implant
For replacement arthroplasty: fracture around implant, dislocation
Re‐operations
Wound healing: superficial, infection, deep sepsis
(c) Postoperative complications:
deep vein thrombosis
pulmonary embolism
pressure sores
myocardial infarction
(d) Postoperative care outcomes: none
(e) Anatomical restoration: none
(f) Final outcome measures:
Mortality at 4, 12, 24, 48 months
Pain at 4, 12, 24, 48 months
Activities of daily living score
Health related quality of life questionnaire
Walking ability (Charnley score)
Movement of the hip (Charnley score)
Failure to regain mobility
(g) Economic cost: none |
| Notes |
Additional information provided by trialists |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
'sealed envelope technique' |
| Allocation concealment (selection bias) |
Unclear risk |
'sealed envelope technique' |
| 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 |
