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. 2008 Apr 23;2008(2):CD006836. doi: 10.1002/14651858.CD006836.pub2

Sanchez‐Sotelo 2000.

Methods Method of randomisation not stated 
 Assessor blinding: not reported 
 Intention‐to‐treat analysis: likely 
 Lost to follow up: probably 0
Participants Teaching hospital, Spain 
 110 participants 
 Inclusion criteria: age 50 to 85 years, AO: A3 (extra‐articular) or C2 (intra‐articular) distal radius fractures. Presentation within 24 hours of fracture. Informed consent. 
 Exclusion criteria: injuries in the ipsilateral upper limb or contralateral wrist; previous injuries to fractured wrist. 
 Classification: AO (A3, C2) (extra‐ and intra‐articular) 
 Sex: 97 female 
 Age: mean 66 years 
 Assigned: 55/55 [bone substitute / POP] 
 Assessed: 55/55 (1 year)
Interventions Timing of intervention: soon after fracture 
 (1) Closed reduction using fingertrap system monitored by fluoroscopy. Debris (loose fragments etc) removed through 1 cm incision and Norian SRS (calcium‐phosphate bone cement) injected into cavity. Below‐elbow cast applied in slight palmar flexion and ulnar deviation for 2 weeks. 
 (2) Closed manipulation under traction and below‐elbow cast applied in slight palmar flexion and ulnar deviation for 6 weeks.
Active assisted movements of digits, elbow and shoulder encouraged in both groups. Heavy loads avoided until 12 weeks.
Outcomes Length of follow up: 12 months; also assessed at 1, 2, 3 and 6 weeks, 3 and 6 months.
(1) Functional: Overall grades clinical scale (Bradway 1989 modification of Green and O'Brien), grip strength, radio‐ulnar and radiocarpal pain (VAS), range of movement (flexion, extension, radial and ulnar deviation, pronation, supination). 
 (2) Clinical: Complications: re‐manipulation and new cast, malunion, median nerve compression, RSD, tendon rupture (EPL), refracture, infection (none), extraosseous Norian SRS deposits / extrusions, extra surgery to remove deposit. 
 (3) Anatomical: X‐ray at above follow‐up times. Volar angle, radial shortening, radial width, ulnar variance, radial angle, intra‐articular gap. Malunion.
Notes All treated by one surgeon.
Earlier abstract (Sanchez‐Sotelo 1999) reported results of 69 participants at 6 months.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment? Unclear risk B ‐ Unclear