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. 2022 Feb 10;2022(2):CD013405. doi: 10.1002/14651858.CD013405.pub2

Dalsgaard 1986.

Study characteristics
Methods Quasi‐randomised; parallel design
Review comparison group: Ender versus SSP
Participants Total number of randomised participants: 101
Inclusion criteria: pertrochanteric fractures
Exclusion criteria: not reported
Setting: single centre, hospital, Denmark
Baseline characteristics
Intervention group 1 (Ender)
  • Age, average (range): 79 (47 to 97) years

  • Fracture classification, stable/unstable, n: 21/36


Intervention group 2 (SSP)
  • Age, average (range): 80 (49 to 93) years

  • Fracture classification, stable/unstable, n: 17/27


Note:
  • study provided no baseline characteristics

Interventions General details: prophylactic antibiotics were not used. 30% of participants were operated on by senior house officers, and remaining were operated on by consultants and senior registrars; regular clinical follow‐up for minimum of 6 months
Intervention group 1:
  • Ender nails (manufacturer not reported)

  • Number randomised to group = 57; losses = not reported, number analysed = 57


Intervention group 2:
  • Sliding nail plate (manufacturer not reported)

  • Number randomised to group = 44; losses = not reported, number analysed = 48

Outcomes Outcomes measured/reported by study authors: unplanned return to theatre (available at six months); operations time; distal slipping; deep infection; shortening of the leg; walking ability
Outcomes relevant to the review: unplanned return to theatre (reported at 6 months); mortality (6 months)
Notes Funding/sponsor/declarations of interest: no details on funding or conflict of interest are provided
Study dates: not reported
Note: 
  • study reported in Danish. We used an English translation of this paper by SU Sjølin.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Randomised using date of birth
Allocation concealment (selection bias) Unclear risk Method of allocation not reported
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk It is not possible to blind surgeons to treatment groups. 
Other performance bias: surgeon experience of both implants Unclear risk Study authors do not report the experience and skills of the surgeons and we could not be certain whether surgeons were equally experienced with both types of implants.
Blinding of outcome assessment: unplanned return to theatre (detection bias) High risk It is not possible to blind surgeons to treatment groups. We judged that knowledge of the type of intervention could influence judgments made by surgeons when assessing this subjective outcome.
Incomplete outcome data (attrition bias)
All outcomes Low risk No losses are reported.
Selective reporting (reporting bias) Unclear risk Study authors did not report pre‐published protocol or clinical trial registration. It is not feasible to effectively assess risk of selective reporting bias without these documents.
Other bias Low risk We identified no other sources of bias.