Sandow 1996.
Methods | Randomisation method: not stated but used the double consent randomisation design of Zelen. Assessor blinding: not stated. Loss to follow‐up: probably none. Intention‐to‐treat analysis: not known. | |
Participants | Royal Adelaide Hospital and Wakefield Orthopaedic Clinic, Australia and UCLA Medical Center, USA 39 people < 26 years old with primary traumatic anterior shoulder dislocation. Age range 14 to 26 years. Exclusion criteria: history of shoulder instability or ligamentous laxity, bony Bankart lesion or rotator cuff tear (queried if diagnosed at surgery thus post‐randomisation exclusion?) | |
Interventions | Period of study: not stated
1. Surgical: arthroscopic stabilisation using a bio‐absorbable implant (Suretac) within 10 (or 7?) days of initial dislocation, then sling for 4 weeks.
2. Non‐surgical: sling for 4 weeks. Both groups had sling for four weeks, then a standard rehabilitation programme. Assigned: 19/20 Analysed: 19/20 (? at 17 months) |
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Outcomes | Length of follow‐up: average 17 months (12 ‐ 36 months). Also objective assessment: 3 and 6 months. 1. Return to previous level of sport. 2. Redislocation. 3. Recurrent instability (dislocation/subluxation). 4. Subsequent requirement for open surgery. 5. Range of movement. 6. Strength. 7. Satisfaction. | |
Notes | Trial presently reported in two abstracts only. Requests for further information sent to Dr Sandow in April and September 2003. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Used the double consent randomised design of Zelen ‐ no information. |
Allocation concealment? | Unclear risk | Unclear. |