Zwick 2009.
| Study characteristics | ||
| Methods | RCT. 2‐arm, parallel‐group design Randomisation of participants |
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| Participants | 19 participants with 28 CTEV feet who presented to a single centre Inclusion criteria: idiopathic CTEV, < 2 weeks of age Exclusion criteria: none stated PARTICIPANT CHARACTERISTICS Ponseti Age mean (SD) weeks: 0.7 (0.8) Sex male:female: 3:6 Characteristics of feet: 9 participants (12 feet) 2 participants (2 feet) opted out Baseline severity: Pirani score 4.6 (1.5) Posteromedial soft tissue release Age mean (SD) weeks: 0.4 (0.4) Sex male:female: 7:3 Characteristics of feet: 10 participants (16 feet) Baseline severity: Pirani score 4.5 (1.1) |
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| Interventions | Ponseti versus surgical intervention Treatment using the Ponseti technique involved long leg casts changed weekly. All participants required an Achilles tenotomy, done under general anaesthesia and then they were placed back into a long leg cast for a further 3 weeks. Correction was maintained in a brace with external rotation of 70 ° for affected feet and 45 ° for unaffected feet. The brace was worn full‐time until 6 months of age, then for 18 hours a day until the child started standing. Once standing, the brace was worn at night until 2 years of age. Following this, participants were placed into custom‐moulded shoes with an insole with a heel counter, and moderate flange at the medial aspect of the cuboid and medial aspect of the first metatarsal head Participants in the surgical group underwent similar weekly manipulative casting as those in the Ponseti group until 6 to 8 months of age. All residual deformities were then treated with a posteromedial release by a Cincinnati incision and fixated with Kirschner wires and long leg casts. Kirschner wires were removed at 4 weeks and casts removed at 6 weeks post‐operatively. Correction was maintained with rigid knee AFOs worn at night until 3 years of age. Moulded orthoses were prescribed once the participant was able to stand and walk Follow‐up average: 42 months |
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| Outcomes | Pirani score PODCI FRS; Laaveg and Ponseti |
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| Conflicts of interest | Quote: "Each author certifies that he or she has no commercial associations that might pose a conflict of interest in connected with the submitted article" | |
| Funding | None reported | |
| Notes | Stopped early secondary to ethical implications. The traditional technique was leading to greater rates of major surgical intervention compared to the Ponseti technique We could not use functional outcome data (PODCI) in a meta‐analysis as data were presented by foot, and bilateral and unilateral cases were combined. IPD were not available for re‐analysis Location: Austria Dates conducted: 2001 to 2003 (end of recruitment) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random‐number table |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of intervention provider not possible. Unable to blind participants or families |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Assessor not blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: "2 patients were not treated per protocol and underwent posteromedial release." Quote: "According to the intention‐to‐treat protocol, these two patients (two feet) remained assigned to the Ponseti group for further assessments and analysis." |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
| Other bias | High risk | Quote: "Because the rate of surgery was higher for the traditional therapy group, patient acquisition was terminated after the preliminary evaluation." |
AFO: ankle foot orthosis CCSR: complete circumferential subtalar release CPM: continuous passive motion CTEV: congenital talipes equinovarus DB: Denis Browne FAS: forefoot abduction shoe FDL: flexor digitorum longus FHL: flexor hallucis longus FRS: Functional Rating System MRI: magnetic resonance imaging OS: orthopaedic shoe OFM: Oxford Foot Model PMR: posteromedial release PODCI: Pediatric Outcomes Data Collection Instrument RCT: randomised controlled trial SD: standard deviation SRF: semi‐rigid fibreglass TATT: tibialis anterior tendon transfer