Svehlik 2017.
| Study characteristics | ||
| Methods | RCT. Prospective 2‐arm, parallel‐group design Randomisation of participants (not feet) |
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| Participants | 19 participants with 28 CTEV feet Inclusion criteria: idiopathic CTEV, infants < 2 weeks of age with no other congenital deformities Exclusion criteria: perinatal problems, suspicion of neurologic or metabolic disorders PARTICIPANT CHARACTERISTICS 2 infants (4 clubfeet) in Ponseti group opted out of allocated treatment but were included in analysis 3 infants lost to follow‐up in surgical group (moved out of area) Ponseti 10 participants, 16 clubfeet Age at follow‐up, mean (SD): 9.81 (0.78) years Characteristics of feet at follow‐up: 12 feet. 3 bilateral: 6 unilateral Sex: male:female 7:5 Baseline severity: median Pirani score at birth: 3.25 Surgical 9 participants,12 clubfeet Age at follow‐ up, mean (SD): 9.85 (0.39) years Sex: male:female: 11:1 Characteristics of feet: 12 feet. 5 bilateral: 2 unilateral Baseline severity: median Pirani score at birth: 3.75 |
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| Interventions | Ponseti versus surgical intervention In the Ponseti group, weekly manipulation and above‐knee casting as in Ponseti method followed by percutaneous Achilles tenotomy and a final cast for 3 weeks. Orthotic management once correction achieved until 2 years of age. Feet were placed in abduction bracing at 70 ° and 45 ° of external rotation for the club foot and the healthy foot in unilateral cases, respectively. Custom‐moulded shoes were provided after 2 years for daily use In the surgical group, casting according to the technique of Johann Bosch until 6 to 8 months with residual foot deformity corrected by posteromedial release (Cincinnati approach) followed by 6 weeks in a plaster cast. Night‐time rigid AFOs were provided after removal of plaster up to 36 months Follow‐up average (SD): 9.8 years (0.6) |
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| Outcomes | Pirani scale FRS Ankle range of motion Oxford Food Model (OFM) PODCI |
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| Conflicts of interest | Quote: "Conflict of Interest: None" | |
| Funding | One or more of the authors has received funding from Land Steiermark, Graz, Austria | |
| Notes | Recruitment was stopped after an interim report indicated a higher number of surgical procedures were required to achieve correction of the clubfoot deformity in the surgical group 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: started 2001, completion date not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation table |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind participants and personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear whether assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 feet were lost to follow‐up. Intention‐to‐treat protocol was used |
| Selective reporting (reporting bias) | Low risk | No selective reporting |
| Other bias | Unclear risk | The trial report did not include sufficient detail to judge whether there could be other bias |