Zwick 2009.
| Methods | RCT. Two‐arm parallel‐group design | |
| Participants | 19 participants with 28 CTEV feet who presented to a single centre Inclusion criteria: idiopathic CTEV, less than 2 weeks of age Exclusion criteria: none stated PARTICIPANT CHARACTERISTICS Ponseti Age mean (SD) weeks: 0.7 (0.8) Sex male (%): 33% Characteristics of feet: 9 participants (12 feet) 2 participants (2 feet) opted out. Intention‐to treat‐analysis was done. Baseline severity: Pirani score 4.6 (1.5) Posteromedial soft tissue release Age mean (SD) weeks: 0.4 (0.4) Sex male (%): 70% Characteristics of feet: 10 participants (16 feet) Baseline severity: Pirani score 4.5 (1.1) |
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| Interventions | Ponseti versus surgical intervention Randomisation was done on participants Treatment using the Ponseti technique was done with long leg casts changed weekly. All participants required an Achilles tenotomy which were done under general anaesthesia and then 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 per 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, 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 via 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 postoperatively. Correction was maintained with rigid knee ankle foot orthoses, 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 Functional Rating System (FRS) Laaveg and Ponseti |
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| Notes | ||
| 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 (performance bias and detection bias) All outcomes | High risk | Blinding of intervention provider not possible. Assessor not blinded. Unable to blind participants or families |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 'As‐treated' analysis done with substantial departure of the intervention received from that assigned at randomisation |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information |
| Other bias | High risk | Stopped early secondary to ethical implications.The traditional technique was leading to greater rates of major surgical intervention compared to the Ponseti technique. Different assessors for different outcome measures |
AFO: ankle foot orthosis
CPM: continuous passive motion
CTEV: congenital talipes equinovarus
FDL: flexor digitorum longus
FHL: flexor hallucis longus
MRI: magnetic resonance imaging
PODCI: Pediatric Outcomes Data Collection Instrument
RCT: randomised controlled trial
SD: standard deviation