Mehdinasab 2008.

Methods	Quasi‐randomised, open‐label, parallel‐group, controlled trial Country: Iran Setting: Two hospitals (Mehr Hospital, Kianpars, Ahwaz and Dept. of Orthopedics, Imam Khomeini Hospital, Azadegan Avenue, Ahwaz) Duration: May 2003 to February 2006
Participants	Participants: 70 children Age: 6 to 11 years of age Sex: 15 girls, 51 boys (of the 66 children followed up) Inclusion criteria: Children with closed fractures of the femoral shaft Exclusion criteria: Open, pathologic,segmental, trochanteric, epiphyseal fractures Multiple trauma
Interventions	Intervention: Open reduction and internal fixation with intramedullary pin and cast (N = 36) A 4 to 5 mm slightly bent pin was inserted retrograde first, into proximal fragment with the hip in flexion, adduction, and internally rotated and after reduction, into distal fragment. Pin end was bent above the greater trochanter subcutaneously. Control of reduction was performed by a C‐ arm fluoroscopy. Then a hip spica cast was applied Control: Skeletal traction by 90–90 technique followed by spica cast (N = 30) In the operating room, under local anaesthesia after insertion of a 3 or 4 mm Steinman pin into proximal tibia, 90‐90 skeletal traction and leg support with sling was applied. Following primary callus formation and early union that was characterised by loss of pain, tenderness and motion at the fracture site, pin was removed and 1½ spica cast was applied
Outcomes	Outcomes reported in the trial and used in this review: Unacceptable malunion Serious adverse events Resource use: length of hospital stay (no measure of dispersion reported) Outcomes reported in the trial but not used in this review: Superficial infection Duration of hospitalisation and total treatment (No measures of dispersion reported) Outcomes sought for this review but not reported in the trial: Functional outcome measures Time to return to usual activities Child satisfaction Parent satisfaction Resource use and other costs.
Notes	Funding: Not stated Notes: Mean follow‐up was 6 months. Range is not provided The authors have reported malunion without separating the acceptable from non‐acceptable shortenings. As the mean of 1 cm falls well within the acceptable limits it is not possible to use this as malunion. Mean of 15º malrotation falls beyond acceptable, hence this is being used as malunion but we do not know if any of these were less than 10º Pain and irritable pin ends have been placed under serious adverse events, however the duration of both were unclear. As the pain is reported to have persisted untill the pins were removed we have considered it as persistent pain and a serious adverse event 70 children were randomised, and 4 were lost to follow‐up; details provided only for 66 children
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "Randomizing of patients into two groups was performed consecutively based on their order of presentation and hospitalization." Comment: Quasi‐randomised. Baseline characteristics of the 2 groups are not provided
Allocation concealment (selection bias)	High risk	Comment: Not concealed. Alternate participants were allotted to either treatment group
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: This was an open‐label study and prone to the risk of performance bias
Blinding of outcome assessment (detection bias) Objective outcomes (e.g. malunion)	Unclear risk	Comment: This was an open‐label study. However, it is unclear if this led to biases in detecting the objective outcomes reported in this trial and used in the review
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: "Out of seventy 6‐11 years old children who were admitted and treated for closed femoral shaft fractures, four patients were lost to follow up and were excluded from study, but 66 cases (51 boys and 15 girls) were available and followed‐up for 6 months." Comment: Only 4 children were lost to follow‐up; outcome data for continuous outcomes were reported without measures of dispersion; some data inconsistencies (e.g. number with pin end irritation were present).
Selective reporting (reporting bias)	Unclear risk	Comment: Although the trial was not prospectively registered, the outcomes to be evaluated stated in the Methods were incompletely reported (no measures of dispersion)
Other bias	Unclear risk	Comment: The trial was conducted in 2 hospitals. Unclear if same standards applied in each hospital