Methods |
Randomisation by: method not stated. |
Participants |
One hospital, Leyenburg, The Hague, Netherlands.
From 1 October 1985 to 1 November 1987
43 patients
Characteristics of participants:
Mean age: Fixation 75.3, arthroplasty 76 (range 71 to 80)
Male: 18 (42%)
Loss to follow‐up: 3 (7%)
Inclusions: intracapsular fracture (Garden III‐IV), aged 71 to 80, good degree of independence according to Broos
Exclusions: none stated |
Interventions |
1. Reduction and fixation with dynamic hip screw versus
2. Bipolar hemiarthroplasty, Stanmore variocup (anterolateral approach) |
Outcomes |
Follow‐up for 36 months
OUTCOMES COLLECTED BY TRIAL
(a) Operative details:
Preoperative delay
Operation time
Perioperative blood loss
(b) Complications related to type of operation:
For internal fixation: delayed or non‐union, femoral head necrosis
For replacement arthroplasty: loosening of prosthetic stem, acetabular protrusion, periarticular calcifications
For both methods: Superficial and deep wound infection, haematoma, secondary intervention
(c) Postoperative complications:
Thromboembolic disease
cardiovascular
Pulmonary infection
cerebrovascular accident
psychiatric disease
urinary tract infection
pressure sore
(d) Post‐operative care outcomes:
Admission time
(e) Anatomical restoration: none
(f) Final outcome measures:
Mortality at 1, 3, 6, 12, 24, 36 months
Clinical effects of secondary intervention, loss of degree of independence, pain, and hip mobility (Shepherd)
(g) Economic cost: none |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Not stated |
Allocation concealment (selection bias) |
Unclear risk |
Not stated |
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 |