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. 2014 Aug 12;2014(8):CD008602. doi: 10.1002/14651858.CD008602.pub3

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)
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
Outcomes Pirani score
PODCI
Functional Rating System (FRS) Laaveg and Ponseti
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