Kaewpornsawan 2007.
| Methods | RCT. Two‐arm parallel‐group design | |
| 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 (%): 55.3% Characteristics of feet: 25 unilateral, 22 bilateral Baseline severity: Dimeglio grade 1, 1 foot; Dimeglio grade 2, 26 feet; Dimeglio grade 3, 35 feet; Dimeglio grade 4, 7 feet Modified complete subtalar release Age mean (range) in months: 6 (3 to 12) Sex male (%): 56.4% Characteristics of feet: 19 unilateral, 20 bilateral Baseline severity: Dimeglio grade 1, 2 feet; Dimeglio grade 2, 28 feet; Dimeglio grade 3, 29 feet; Dimeglio grade 4, 0 feet |
|
| Interventions | Modified posteromedial release versus modified complete subtalar release for clubfoot after failed conservative treatment Randomisation of participants (not feet) 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 postoperative care. Kirschner wires were removed at 6 weeks postoperatively. Long leg casts remained in situ for 12 weeks postoperatively After cast removal, orthopaedic shoes or Denis‐Brown boots were prescribed (length of time not stated) Follow‐up average: 19.4 months |
|
| Outcomes | Ponseti score Turco evaluation Dimeglio scale |
|
| Notes | Basline assessment of groups P = 0.06 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Simple randomisation by envelope |
| Allocation concealment (selection bias) | Unclear risk | "The surgeon blindly opened the envelope that indicated the type of surgery." Unsure if sequentially numbered or opaque |
| Blinding (performance bias and detection bias) All outcomes | High risk | Assessor blinding not stated. Intervention provider unable to be blinded. Participant blinding unlikely to affect outcome |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
| Selective reporting (reporting bias) | Unclear risk | Insufficent information to permit judgement |
| Other bias | Unclear risk | Prior treatment was not outlined |