Sud 2008.
| Study characteristics | ||
| Methods | Quasi‐RCT. 2‐arm, parallel‐group design Randomisation of participants (not feet) |
|
| Participants | 53 participants with 81 CTEV feet who presented to a single centre Inclusion criteria: < 3 months of age, idiopathic CTEV Exclusion criteria: non‐idiopathic CTEV, > 3 months of age PARTICIPANT CHARACTERISTICS 8 participants lost to follow‐up and excluded prior to data analysis Ponseti Age mean (SD) days: 31.75 (27.4) Sex male:female: 14:9 Characteristics of feet: 23 participants, 36 feet. 26 bilateral (13 participants), 4 right, 6 left Baseline severity (Diméglio scale score mean (SD)): 14.39 (3.2) Kite Age mean (SD) days: 26.06 (21.4) Sex male:female: 17:5 Characteristics of feet: 22 participants, 31 feet. 18 bilateral (9 participants), 5 right, 8 left Baseline severity (Diméglio scale score mean (SD)): 16.19 (2.8) |
|
| Interventions | Ponseti versus Kite In the Ponseti group, weekly manipulation and casting was done until correction or 1 year (whichever came first). Correction was defined as 50 ° to 60 ° external rotation and 15 ° dorsiflexion with or without an Achilles tenotomy. Following correction, feet were placed in abduction bracing at 50 ° to 60 ° of external rotation, worn full time for 2 to 3 months then at night until 2 to 4 years of age In the Kite group, manipulation and casting was done until the foot was corrected. Correction was maintained in a night brace in dorsiflexion and slight valgus Follow‐up average: 26 months |
|
| Outcomes | Diméglio scale Range of movement Function ‐ squat, independent walking, pain, participation in games |
|
| Conflicts of interest | None stated | |
| Funding | None stated | |
| Notes | Location: India Dates conducted: March 2003 through February 2004 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Alternate allocation |
| Allocation concealment (selection bias) | High risk | Alternate allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Intervention provider unable to be blinded. Participant blinding unlikely to affect outcome |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 8 participants were excluded or lost to follow‐up and excluded from analysis |
| Selective reporting (reporting bias) | High risk | Prespecified outcomes were unclear in Methods |
| Other bias | Unclear risk | Insufficient information to permit judgment |