Skip to main content
. 2015 Mar 30;2015(3):CD010261. doi: 10.1002/14651858.CD010261.pub2

Guo 2010.

Methods Randomisation: participants were allocated a sequential study number but there was no mention of method otherwise
 Assessor blinding: there was no assessor blinding
Length of follow‐up: 12 months
Participants First Affiliated Hospital of Soochow University, Suzhou, China
 Period of study: July 2005 to January 2008
 111 participants each with distal metaphyseal fracture of the tibia. There were 26 participants "who had not reached one year by the time of the study."
 Sex (of 85): 35 female, 50 male
 Age: mean 44.3 years, range 23 to 70
 Fracture type: AO/OTA 43‐A1:26, 43‐A2: 28, 43‐A3: 31
Unknown number of open fractures (Gustilo type I). Most participants had a fractured fibula (19 that were surgically fixed were excluded)
Inclusion criteria
1. Distal metaphyseal fracture of tibia
2. Presence of a distal fragment of at least 3 cm in length with no articular incongruity (OTA type 43‐A fracture)
Exclusion criteria
1. Individuals with pathological fractures, non‐osteoporotic osteopathies such as endocrine disorders, rheumatologic disorders, diabetes mellitus, renal disease, immunodeficiency states, mental impairment or difficulty in communication
2. Those with open fractures according to Gustilo and Anderson type II or type III or fractures with a displaced intra‐articular fragment
Assigned: 57/54 participants (intramedullary nail/plate)
Analysed: 44/41 (12 months)
Interventions 1. Closed reduction and intramedullary nailing (IMN) (S2 nailing system; Stryker, Schönkirchen, Germany). Nails were inserted after reaming. Static locking applied in all cases.
2. Closed reduction and locking compression plate (LCP) (LCP; Synthes, Bettlach, Switzerland) applied with minimally percutaneous plate osteosynthesis (MIPO) technique.
Operation was usually performed on day of injury. However, operations were delayed 5 to 10 days in 5 plate group participants because of excessive swelling or bruising.
Other care: All received prophylactic antibiotics. Same postoperative care for both groups. Sutures removed after 14 or 15 days. Ankle was immobilised on a short‐leg cast or splint for 3 weeks. Range of motion ankle exercises were encouraged. Timing of partial and full weight‐bearing was on an individual basis.
Outcomes
  • AOFAS functional score

  • Re‐operation

  • Delayed union, non‐union, malunion (malalignment)

  • Pain

  • Function

  • Wound problem including delayed wound healing and superficial wound infection

  • Time to union

  • Radiation time, operation time

  • Implant removal questionnaire. Implant removal after the end of the follow‐up period was also reported

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were allocated a sequential study number. There was no mention how this was done.
Allocation concealment (selection bias) High risk Participants were allocated a sequential study number. Thus it appears that the sequence was predictable and allocation was not concealed.
It was stated there were "no exclusions after randomisation" but then stated that "If the associated fibular fracture was fixed, the patient was excluded from the study". This applied to "ten patients in the IMN group and nine in the LCP group". reported that 19 participants whose associated fibular fracture was fixed surgically were excluded.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The difference between the two methods means that blinding is not possible for the surgeon and unlikely for the participants. There was no statement on blinding.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcomes were assessed by the two of the three operating surgeons involved in the treatment.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "The remaining 26 patients had not reached one year by the time of the study."
"Ten patients in the IMN group and nine in the LCP group were excluded due to fixation of fibular fracture." Contradictory statements mean that it is unclear how many were excluded from the trial.
Selective reporting (reporting bias) Unclear risk Protocol unavailable and results reported in a different way between abstract and text. Subsequent correction published.
Other bias Unclear risk Since the baseline characteristics of 26 participants (23% of 111) were not provided, we cannot tell if the baseline characteristics were balanced. Similar numbers in the 2 groups who had surgically fixed fibular fractures (10 in nail group and 9 in plate group) but these people were excluded; it is unclear whether these were counted in the 111 participants. All operations were carried out by the three senior surgeons. Postoperative care was reported to be comparable.