El‐Deeb 2007.
| Study characteristics | ||
| Methods | Quasi‐RCT. 2‐arm, parallel‐group design Randomisation of feet (not participants) |
|
| 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:female): 41:5 Characteristics of feet: 11 left, 15 right, 20 bilateral Baseline severity: 51 feet Diméglio grade IV (very severe), 15 feet Diméglio grade III (severe) Talocalcaneal interosseous ligament released Characteristics of feet: not stated Talocalcaneal interosseous ligament not released Characteristics of feet: not stated |
|
| Interventions | Talocalcaeal interosseous ligament release versus control in posteromedial soft tissue release for resistant CTEV Feet were allocated equally on an alternate basis Post‐operative 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 1 year Follow‐up average in months: 28 (24 to 36) |
|
| Outcomes | Radiological: x‐ray Radiological: MRI scans at 5 months post‐operatively 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) |
|
| Conflicts of interest | None declared | |
| Funding | None declared | |
| Notes | Location: Egypt (assumed) Dates conducted: Not stated |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Alternate sequence generation Unsure if groups were comparable at baseline |
| Allocation concealment (selection bias) | High risk | Alternate sequence generation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind intervention provider. Unclear if families were aware of which surgery was done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if assessors were blinded |
| 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 | The trial report did not include sufficient detail to judge whether there could be other bias |