Wang 2007.
| Methods | Quasi‐randomised controlled trial | |
| Participants | Setting: Taiwan Size: a total of 59 fractures in 56 patients. There was one exclusion in each group, leading to 27 fractures in 27 patients in the test and 30 fractures in 27 patients in the control. Baseline characteristics: mean (range) age was 34.2 years (15 to 81), 40 males and 16 females. Inclusion: patients with acute, displaced, high energy trauma diaphyseal fractures of the femur and tibia that required reduction and internal or external fixation. Exclusion: pathological fracture, active infection, coagulopathy, immunosuppression, pregnancy, cardiac pacemaker, skeletal immaturity, poor compliance. |
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| Interventions | All closed fractures were treated with open or closed reduction and internal fixation with intra‐medullary nailing or plate fixation. Patients with type III‐C open fractures were initially treated with surgical debridement of the wounds and external fixator for fracture stabilization. Delayed open or closed reduction and internal fixation was performed when the soft tissues were optimised. All other open fractures were treated with primary open reduction and internal fixation. Postoperative management included early ambulation with no weight bearing allowed through the affected limb; quadriceps and hamstring and lower limb joint range of motion exercises. Test: participants in the study group received shockwave treatment immediately after surgery under the same anaesthesia. For patients with type III‐C open fractures, shockwave treatment was performed after delayed open reduction and internal fixation for the fractures. The source of shockwaves was from an OssaTron (High Medical Technology, Kreulingen, Switzerland). Shockwaves were performed with patients on the fracture table. The fracture site was verified with C‐arm X‐rays, and the depth of treatment was confirmed with the control guide of the device under C‐arm imaging. Surgical lubrication gel was applied to the area of skin in direct contact with the shockwave tube. Each fracture site was treated with 6,000 impulses of shockwave at 28 kV (equivalent to 0.62 mJ/mm² energy flux density). Shockwaves were applied in two planes with equal dosage in each plane as a single session. Control: participants in the control group received open reduction and internal fixation without shockwave treatment after surgery. |
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| Outcomes | Follow‐up schedule: 1, 3, 6 and 12 months. Primary: proportion of union at 12 months. Secondary: proportion of union at earlier time points, fracture alignment, pain (VAS), weight bearing status, adverse events. |
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| Notes | Authors have assumed independence between observations from multiple fractures in a single participant. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "[The study group] who had surgery on odd days of the week, and the control group ... who had surgery performed on even days of the week" Comment: Quasi‐randomised study. |
| Allocation concealment (selection bias) | High risk | Quote: "[The study group] who had surgery on odd days of the week, and the control group..who had surgery performed on even days of the week" Comment: Unclear whether method of randomisation known, but would be easy to identify pattern. |
| Blinding (performance bias and detection bias) Patient‐reported measures | Unclear risk | Quote: "Patients in the control group ... without shockwave treatment after surgery." Comment: It is not reported whether the participants were blind to their allocation. |
| Blinding (performance bias and detection bias) Objective measures | Low risk | Quote: "An independent examiner blinded to the nature of the study protocol performed the examination." |
| Incomplete outcome data (attrition bias) Patient‐reported measures | High risk | Quote: "Two patients were excluded from the final analysis because of postoperative deep infection and osteomyelitis." Comment: This was consistent with the eligibility criteria but is an unusual means to handle data from participants developing adverse events. |
| Incomplete outcome data (attrition bias) Objective measures | High risk | Quote: "Two patients were excluded from the final analysis because of postoperative deep infection and osteomyelitis." Comment: This was consistent with the eligibility criteria but is an unusual means to handle data from participants developing adverse events. |
| Selective reporting (reporting bias) | Unclear risk | No protocol available. |
| Other bias | Low risk | Quote: "56 patients with 59 .... fractures" Some participants had two fractures which may have been randomised independently. No statistical adjustments were reported to allow for this |
| Selection bias (imbalance in baseline characteristics) | Unclear risk | The distribution of smoking status between the groups is not reported. |