Kaewpornsawan 2007.
| Study characteristics | ||
| Methods | RCT. 2‐arm, parallel‐group design Randomisation of participants (not feet) |
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| Participants | 86 participants with 128 CTEV feet Inclusion criteria: idiopathic CTEV which failed conservative treatment (treatment unknown), requiring surgery Exclusion criteria: children with arthrogryposis multiplex congenita, myelomeningocoele, cerebral palsy, syndromic clubfoot. Failed previous CTEV surgery PARTICIPANT CHARACTERISTICS Modified posteromedial release Age mean (range) in months: 5.8 (3 to 12) Sex (male:female): 26:21 Characteristics of feet: 25 unilateral, 22 bilateral Baseline severity: Diméglio grade 1, 1 foot; Diméglio grade 2, 26 feet; Diméglio grade 3, 35 feet; Diméglio grade 4, 7 feet Modified complete subtalar release Age mean (range) in months: 6 (3 to 12) Sex (male:female): 22:17 Characteristics of feet: 19 unilateral, 20 bilateral Baseline severity: Diméglio grade 1, 2 feet; Diméglio grade 2, 28 feet; Diméglio grade 3, 29 feet; Diméglio grade 4, 0 feet |
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| Interventions | Modified posteromedial release versus modified complete subtalar release for clubfoot after failed conservative treatment Modified posteromedial release: standard posteromedial approach. Lengthening of tendo Achilles and tibialis posterior. Release of the origin of abductor hallucis, capsulotomy of the talonavicular, posterior tibiotalar, the talocalcaneal and medial calcaneocuboid joints. Division of plantar, calcaneofibular, superficial deltoid, spring ligament and master knot of Henry. In cases with residual toe flexion, FHL and FDL were lengthened. Kirschener wires were inserted through the talonavicular and talocalcaneal joint Modified subtalar release: a Cincinnati incision was used. The talocalcaneal and deep deltoid ligament were preserved. The talonavicular and calcaneocuboid joint were opened medially and laterally. Kirschener wires were inserted through the talonavicular and talocalcaneal joint Both groups had the same post‐operative care. Kirschner wires were removed at 6 weeks post‐operatively. Long leg casts remained in situ for 12 weeks post‐operatively After cast removal, orthopaedic shoes or Denis Browne boots were prescribed (length of time not stated) Follow‐up average: 19.4 months |
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| Outcomes | Ponseti score Turco evaluation Diméglio scale |
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| Conflicts of interest | None declared | |
| Funding | None declared | |
| Notes | Baseline assessment of groups P = 0.06 Location: Thailand Dates conducted: operations performed between 1996 and 2006 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Simple randomisation by envelope. Prior treatment was not outlined, so insufficient information on baseline characteristics |
| Allocation concealment (selection bias) | Unclear risk | Quote: "The surgeon blindly opened the envelope that indicated the type of surgery." Comment: Unsure if sequentially‐numbered or opaque |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Intervention provider could not be blinded. Participant blinding unlikely to affect outcome |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Assessor blinding not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
| Selective reporting (reporting bias) | Unclear risk | The trial report did not include sufficient detail to judge selective reporting |
| Other bias | Unclear risk | The trial report did not include sufficient detail to judge whether there could be other bias |