Methods |
Randomisation by: sealed envelopes technique |
Participants |
One hospital, Karolinska Institute at Stockholm Söder Hospital, Sweden.
60 patients.
Characteristics of participants:
Mean age: 84 years.
Male: 6 (10%)
Loss to follow‐up: 1 (2%)
Inclusions: short portable mental status questionnaire of less than 3/10 or a diagnosis of dementia, displaced fracture of the femoral neck, aged 70 years plus, able to walk independently
Exclusions: pathological fractures, fracture more than 24 hours from occurrence, rheumatoid arthritis, osteoarthritis |
Interventions |
1. Reduction and fixation with two cannulated screws versus
2. Uncemented Moore unipolar hemiarthroplasty inserted via an anterolateral modified Hardinge approach |
Outcomes |
Follow‐up for 24 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: none
(d) Postoperative care outcomes: none
(e) Anatomical restoration: none
(f) Final outcome measures:
Mortality at 4, 12, 24 months
Pain at 4, 12, 24 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 supplied by trialists |
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 technique' |
Blinding (performance bias and detection bias)
Were the assessors of pain and function at follow‐up blinded to the treatment allocation |
High risk |
not mentioned |