Maripuri 2013.

Study characteristics
Methods	RCT. Prospective 2‐arm, parallel‐group design Randomisation of participants (not feet)
Participants	26 children with 33 CTEV feet Inclusion criteria: idiopathic clubfeet, no previous treatment, no contraindications to Ponseti treatment Exclusion criteria: clubfoot associated with an overall genetic syndrome (syndromic club foot); teratologic clubfoot associated with a neurological disorder such as meningomyelocoele; parents or guardians declined to participate; no valid consent could be obtained or an eligibility assessment was not performed by the lead clinician PARTICIPANT CHARACTERISTICS Below‐knee casting group Median age (range): 13 (1 to 40) days Sex (male:female): 10:3 Characteristics of feet: 16 feet in total (13 participants), 3 bilateral, 10 unilateral (7 right, 3 left) Baseline severity: mean Pirani score at presentation (range): 4.3 (2.5 to 5.5) Above‐knee casting group Median age (range): 10 (5 to 20) days Sex (male:female): 10:3 Characteristics of feet: 17 feet in total (13 participants), 4 bilateral, 9 unilateral (4 right, 5 left) Baseline severity: mean Pirani score at presentation (range): 4.05 (2.5 to 6)
Interventions	Above‐knee casting versus below‐knee casting All feet were evaluated to decide how many casts were required to correct the deformity and need for tendo Achilles tenotomy. Criteria for tenotomy was minimum abduction of 40 °, the heel in valgus and the anterior process of the calcaneum lateral to the tala head. 2 slips (plaster displacement far enough to retract the toes or the plaster falling off) or a plaster treatment over 8 weeks without achieving correction were considered as a treatment failure. If failure occurred in a foot treated by a below‐knee plaster, that foot was reverted to above‐knee plaster Follow‐up: Trial stopped at the point half the planned sample size had been recruited due to high failure rate in the below‐knee group
Outcomes	Pirani scale Time to readiness for tenotomy Time to full correction Risk of failure due to displacement of the cast, over‐long treatment
Conflicts of interest	Quote: "No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of the article"
Funding	Financial support provided by Orthopaedic Institute at the RJAH Orthopaedic Hospital in Oswestry, UK
Notes	6 failures in the below‐knee group (4 plaster slippages within 8 weeks, 2 casting more than 8 weeks) 1 failure in the above‐knee group (casting more than 8 weeks) Location: UK Dates conducted: between 2010 and 2012
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The details of how the randomisation was undertaken was not stated
Allocation concealment (selection bias)	Low risk	Opaque sealed envelope was drawn by research nurse in front of parents, number given and participants allocated to a group
Blinding of participants and personnel (performance bias) All outcomes	High risk	Unable to blind participants or personnel
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unclear if outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data
Selective reporting (reporting bias)	Low risk	No selective reporting
Other bias	High risk	Following an interim analysis the trial was stopped due to a high failure rate in above‐knee group