El‐Deeb 2007.
| Methods | Quasi‐RCT. Two‐arm parallel‐group design | |
| Participants | 46 participants with 66 feet with resistant idiopathic CTEV, referred to a single centre Inclusion criteria: idiopathic CTEV which failed conservative treatment (techniques unknown), requiring posteromedial soft tissue release Exclusion criteria: none stated PARTICIPANT CHARACTERISTICS Age mean (range) in months: 9 (3 to 24) Sex male (%): 89% Characteristics of feet: 11 left, 15 right, 20 bilateral Baseline severity: 51 feet Dimeglio grade IV (very severe), 15 feet Dimeglio grade III (severe) Talocalcaneal interosseous ligament released Characteristics of feet: not stated Talocalcaneal interosseous ligament not released Characteristics of feet: not stated |
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| Interventions | Talocalcaeal interosseous ligament release versus control in posteromedial soft tissue release for resistant CTEV Randomisation of feet (not participants) Feet were allocated equally on an alternate basis Postoperative care was the same in both groups. Long leg plaster in corrected position which was then changed every 3 weeks into an overcorrected position. Total time immobilised in cast was 12 weeks. Antivarus boots or splints then worn for one year Follow‐up average in months: 28 (24 to 36) |
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| Outcomes | Radiological: x‐ray Radiological: MRI scans at 5 months postoperatively in 40 participants (20 from each group) Scoring system based on combination of clinical and radiographic outcomes at an average of 28 months (range, 24 to 36 months) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Alternate sequence generation |
| Allocation concealment (selection bias) | High risk | Alternate sequence generation |
| Blinding (performance bias and detection bias) All outcomes | High risk | Unable to blind intervention provider. Unsure if assessors were blinded. Unsure if families were aware which surgery was done |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Some participants had MRI scans. Unable to provide to all participants due to logistics and cost, unsure how the limited numbers were selected |
| Selective reporting (reporting bias) | Unclear risk | The Simons system of reporting was modified. Mentioned cosmetic appearance, clinical range and strength, but did not report on these |
| Other bias | Unclear risk | Unsure if groups were comparable at baseline |