| Methods |
Randomisation by: random numbers using sealed opaque envelopes. |
| Participants |
One hospital, Ashrus, Denmark.
From 2 January 1975 to 31 August 1978
102 patients
Characteristics of participants:
Median age: in each group 80.5 and 70 years.
Male: 32 (31%)
Reported that the fixation group included more patients with a poor prognosis.
Loss to follow‐up: 2 (2%)
Inclusions: Fresh and non‐pathological fractures of the femoral neck, displaced to stage III or IV Garden, aged 70 years plus
Exclusions: pathological fractures (by inference) |
| Interventions |
1. Reduction and fixation with 4 AO screws versus
2. Uncemented Moore unipolar hemiarthroplasty inserted via a posterior approach |
| Outcomes |
Follow‐up for 24 months
OUTCOMES COLLECTED BY TRIAL
(a) Operative details: length of surgery in minutes
(b) Complications related to type of operation:
For internal fixation: fixation failure, early redisplacement, non‐union, avascular necrosis
For replacement arthroplasty: prosthesis loosening, settling, acetabular protrusion, periarticular calcification (grade 3), allergy to metal
For both methods of treatment:per or subtrochanteric fracture, femoral shaft fracture
Re‐operations
Wound healing: superficial, infection, deep sepsis, haematoma
(c) Postoperative complications:
Deep vein thrombosis, Pulmonary embolism
Medical complications: cardiopulmonary, neurological, gastrointestinal, urinary retention, pressure sore
(d) Postoperative care outcomes:
Mean time to weight‐bearing
(e) Anatomical restoration: none
(f) Final outcome measures:
Mortality at 1, 6, 12, 24 months
Need for walking aids
Social function Stitchfield's hip assessment (incorporates pain, range of movement, ability to walk)
(g) Economic cost: none |
| Notes |
Additional information from Dr Jensen |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
random numbers using sealed opaque envelopes. |
| Allocation concealment (selection bias) |
Unclear risk |
random numbers using sealed 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 |
