Summary of findings 1. Treatment of initial congenital talipes equinovarus (CTEV; clubfoot).
Patient or population: participants with CTEV at initial presentation
Settings: single centres
Intervention: various Comparison: various | |||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Certainty of the evidence (GRADE) | Comments | ||
Assumed risk | Corresponding risk | ||||||
Control | Intervention | ||||||
Function | 2 trials reported on function using validated scales, but raw data were not available for analysis. 2 trials reported on function using non‐validated methods. |
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Foot alignment Pirani score. Scale from: 0 to 6. A lower score indicates better alignment | Ponseti vs Kite technique Follow‐up: 10 weeks |
Kite technique The mean foot alignment score in the Kite group was 2.12 pointsa |
Ponseti technique The mean foot alignment score in the Ponseti group was 1.15 points lower (1.32 lower to 0.98 lower) |
‐ | 38 (1 study) | ⊕⊕⊝⊝ Lowb | When treated at birth, foot alignment may be better after Ponseti plaster casting than after Kite plaster casting. |
Ponseti technique vs traditional treatment (plaster casting and surgery) Follow‐up: 42 months |
Traditional treatment The mean foot alignment score in the traditional treatment group was 1.8 pointsc |
Ponseti technique The mean foot alignment score in the Ponseti group was 1.50 points lower (2.28 lower to 0.72 lower) |
‐ | 28 (1 study) |
⊕⊝⊝⊝ Very lowd,e | The certainty of evidence is too low to draw conclusions about foot alignment after Ponseti casting compared to traditional treatment (plaster casting and surgery) | |
Ponseti technique, semi‐rigid fibreglass compared with plaster of Paris casting for CTEV Follow‐up: 30.8 months |
Ponseti, plaster of Paris cast The mean foot alignment score in the plaster of Paris cast group was 1.0 pointsf |
Ponseti, fibreglass cast The mean foot alignment score in the fibreglass cast group was 0.46 points higher (0.07 lower to 0.99 higher) |
‐ | 30 (1 study) | ⊕⊕⊝⊝ Lowg | When treated at birth using Ponseti casting, semi‐rigid fibreglass may be as effective as plaster of Paris. | |
Gait assessment | Not reported ‐ no trial assessed gait using a validated measure | ||||||
Health‐related quality of life | 2 trials assessed health‐related quality of life using a validated measure, but raw data were not available for analysis | ||||||
Adverse events | Ponseti vs. Kite Follow‐up: 10 weeks |
In the Kite vs Ponseti comparison 1 trial reported plaster sores and skin ulceration with casting without specifying whether in the Kite or Ponseti group. The remaining trials did not report adverse events. Following relapse, the risk difference for major surgery in the Kite group was 25% and 50% higher in 2 trials. The third trial reported 11/50 relapses in the Kite group. Management was not stated. |
⊕⊕⊝⊝ Lowb | ‐ | |||
Ponseti vs. traditional treatment (plaster casting and surgery) Follow‐up: 42 months |
Infant discomfort in orthoses was reported (1 participant, 11%). Relapse was seen in 2/9 participants in the Ponseti group within 2 months of completion of serial casting. The traditional treatment required 50% more surgical procedures on follow‐up compared to the Ponseti group. | ⊕⊝⊝⊝ Very lowd,e | ‐ | ||||
Ponseti technique, semi‐rigid fibreglass compared with plaster of Paris casting for CTEV Follow‐up: 30.8 months |
1 trial (N = 11) reported minor skin irritation and plaster casts slippage. 1 trial (N = 30) reported a relapse rate of 1/18 in the fibreglass group and 3/12 in the Ponseti group. This trial did not report any adverse events. |
⊕⊕⊝⊝ Lowg | ‐ | ||||
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; CTEV: congenital talipes equinovarus | |||||||
GRADE Working Group grades of evidence High certainty: Further research is very unlikely to change our confidence in the estimate of effect. Moderate certainty: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low certainty: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low certainty: We are very uncertain about the estimate. |
aFinal mean Ponseti score of pooled results from three strata. bDowngraded twice: once for study limitations and once for imprecision. There was insufficient information to assess allocation concealment. Blinding of providers was not possible, but observers were blinded. The study had 38 participants. cFinal mean Pirani score in control group. dDowngraded twice for study limitations: there was a high risk of performance bias, and outcome assessment was not blinded. The risk of bias was unclear in several other domains, including allocation concealment. An early stopping rule was instigated. eDowngraded for imprecision: The trial had 28 participants. fFinal mean Pirani score for control group (plaster of Paris casting). gWe downgraded the evidence twice: once for study limitations, as blinding of participants and personnel was not possible and it was unclear whether outcome assessors were blinded, and once for imprecision, as the trial included 30 participants.