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. |
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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. |
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Notes | All treated by one surgeon. Earlier abstract (Sanchez‐Sotelo 1999) reported results of 69 participants at 6 months. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |