Gintautiene 2016.
| Study characteristics | ||
| Methods | RCT. Prospective 2‐arm, parallel‐group design Randomisation of participants (not feet) |
|
| Participants | 44 children with 63 feet were managed in a single centre from 2011 ‐ 2013. 5 participants (8 feet, 12.7%) dropped out and were excluded. Data from 39 children (55 feet) were collected Inclusion criteria: Idiopathic CTEV, up to 3 months of age, written consent to participate in the study, patients who underwent no other prior treatment Exclusion criteria: Patients who refused to participate in the study, severe concurrent genetic or neurological pathology that is likely to affect the child's physical development and/or the function of the foot PARTICIPANT CHARACTERISTICS Characteristics of feet: 17 right (43.59%), 6 left (15.38%), 16 bilateral (41.03%) Ponseti group Baseline severity (mean (SD)): Pirani score 5.05 (0.66), Diméglio score 11.93 (2.72) Characteristics of feet: 16 right, 12 left Age mean: 19.04 days Sex (male:female): 13:8 TATT group Baseline severity (mean (SD)): Pirani score 5.09 (0.75), Diméglio score 12.63 (2.34) Characteristics of feet: 17 right, 10 left foot Age mean: 15 days Sex: male:female: 14:4 |
|
| Interventions | Ponseti method versus early tibialis anterior tendon transfer for idiopathic CTEV Ponseti group underwent a traditional Ponseti casting. Percutaneous Achilles tenotomy was performed when equinus was persistent. Feet were immobilised for 3 weeks. Abduction brace was worn 23 hours a day up to 6 months of age, followed by 14 to 16 hours a day up to 2 years of age TATT group received the same intervention up to 6 months of age. At 6 months underwent TATT. Foot was immobilised for 5 weeks. No brace was worn after removal of plaster Follow‐up: 2 years and 5 to 12 years |
|
| Outcomes | Pirani scale, Diméglio scale Foot range of movement, e.g. dorsiflexion, plantar flexion, supination, pronation, radiological examination |
|
| Conflicts of interest | Quote: "The authors have no conflict of interest to declare" | |
| Funding | Not reported | |
| Notes | Relapse and long‐term (5‐ to 12‐year) follow‐up reported Location: Lithuania Dates conducted: 2011 to 2013 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated |
| Allocation concealment (selection bias) | Unclear risk | Quote: "At baseline patients were allocated randomly by the sealed envelope technique to one of two groups" Comment: Unclear how many bilateral and unilateral cases were allocated to each group |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of participants and personnel was not possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of assessors was not stated |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 8 feet dropped out, but it was unclear if an intention‐to‐treat analysis was used |
| Selective reporting (reporting bias) | Low risk | No selective reporting |
| Other bias | Low risk | |