Mirzatolooei 2011.

Methods	Study design: single‐centre, 2‐group, parallel‐design RCT Duration of the study: October 2007‐April 2009 Protocol was published before recruitment of participants: not reported, but no protocol was published Details of trial registration: not registered Funding sources: none known
Participants	Place of study: tertiary trauma centre in Iran Number of participants assigned: 60 participants (29 surgical; 31 conservative) Number of participants assessed: 50 participants (26 surgical; 24 conservative) Inclusion criteria Aged 18‐65 years A comminuted (≥ 3 fragments in the fracture site as seen on primary radiography) displaced middle third clavicle fracture No medical contraindications to general anaesthesia Exclusion criteria Any fracture in an upper extremity distal to the shoulder Concomitant fracture in the distal or medial third of the clavicle Any weakness in the upper extremity resulting from a head or neurovascular injury Pathological fracture An old fracture (> 3 weeks before the accident) Inability to complete follow‐up Age Surgical group (mean): 36.0 years Conservative group (mean): 35.3 years Gender of participants assessed (male/female) Surgical group: 20/6 Conservative group: 21/3 Classification of injury: not reported
Interventions	Timing of intervention: not specified; however, participants with intervention > 3 weeks after injury were excluded. Type of surgical intervention: open reduction and plate fixation with 3.5‐mm reconstruction plates on the superior surface of the clavicle. Type of conservative intervention: a commercial sling was used and an elastic cotton band was wrapped around the participant's chest and arm to limit abduction and external rotation of the arm. No attempt was made for closed reduction. Rehabilitation Surgical group: passive ROM exercises were started after 10 days. At 3 weeks after surgery, strengthening exercises were begun and progressed during the following 3 weeks. Conservative group: rehabilitation was not specified Any co‐interventions: not reported
Outcomes	Length of follow‐up Follow‐up was 1 year Participants were evaluated at 1 month and at 3 and 12 months Loss to follow‐up: 10 participants were lost to follow‐up at 1 year Surgical group: 3 participants were lost at 1 year Conservative group: 7 participants were lost at 1 year Primary outcomes Function or disability measured by DASH and Constant score Failure of treatment (symptomatic non‐union) Secondary outcomes Other treatment failure measured by: cosmetic results: hardware prominence, unsightly scar, asymmetry symptomatic malunion Adverse events measured by: short‐term follow‐up: wound infection long‐term follow‐up: skin dysaesthesia, hypertrophic scar, weakness, limitation of motion and plate elevation
Notes	This study population included some participants with open clavicle fractures (7 participants in the surgical group and 5 participants in the conservative group). SDs of DASH and Constant scores were obtained by personal contact with the study authors. Composite adverse events: surgery: infection (n = 1); malunion (n = 4); discomfort leading to implant removal (n = 1); skin dysaesthesia (n = 2). Conservative: malunion (n = 19); neurological claudication (n = 2). In Analysis 1.14 we used event rates 8 for surgery and 19 for conservative. Cosmetic result events: surgery: hardware prominence (n = 1), unsightly scar (n = 2). Conservative: asymmetry (n = 2). In Analysis 1.11 we used event rates 3 for surgery and 2 for conservative.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The method of generating the random sequence was not reported.
Allocation concealment (selection bias)	Low risk	Opaque and sealed envelopes were used.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessors were not blinded.
Incomplete outcome data (attrition bias) All outcomes	High risk	7 participants in the conservative intervention did not complete 1‐year follow‐up and the study authors did not perform an intention‐to‐treat analysis. In addition, 3 participants in the surgical group did not undergo surgery and were excluded.
Selective reporting (reporting bias)	High risk	The study authors did not report outcomes at each time point. It was unclear when the outcomes were collected, and the study authors reported only P values.
Other bias	High risk	No baseline data were provided.