Similar disability ratings were found in adults with an acute distal tibia fracture who were surgically treated to either intramedullary (IM) nail fixation or locking plate fixation at six months, however, recovery across all outcomes was found to be faster in the IM nail fixation group with higher cost-effectiveness, according to a study published in the journal Health Technology Assessment.
Costa ML and his associates conducted a randomized trial to assess disability, quality of life, complications and resource use in patients treated with intramedullary (IM) nail fixation versus locking plate fixation in the 12 months following a fracture of the distal tibia.
The trial included a total of 321 patients. Exclusions included excluded if patients had open fractures, fractures involving the ankle joint, contraindication to nailing or inability to complete questionnaires.
In IM nail fixation a metal rod is inserted into the hollow center of the tibia whereas in locking plate fixation a plate is attached to the surface of the tibia with fixed-angle screws.!61 patients underwent IM nail fixation and 160 patients underwent locking plate fixation.
The primary outcome measure was the Disability Rating Index (DRI) score, which ranges from 0 points (no disability) to 100 points (complete disability), at 6 months with a minimum clinically important difference of 8 points. The DRI score was also collected at 3 and 12 months.
The secondary outcomes were the Olerud–Molander Ankle Score (OMAS), quality of life as measured using EuroQol-5 Dimensions (EQ-5D), complications such as infection, and further surgery. Resource use was collected to inform the health economic evaluation.
The study found that:
- There was no statistically significant difference in DRI score at 6 months [IM nail fixation group, mean 29.8 points; locking plate group, mean 33.8 points].
- There was a statistically significant difference in DRI score at 3 months in favor of IM nail fixation (IM nail fixation group, mean 44.2 points; locking plate group, mean 52.6 points), but not at 12 months (IM nail fixation group, mean 23.1 points; locking plate group).
- Secondary outcomes showed the same pattern, including a statistically significant difference in mean OMAS and EQ-5D scores at 3 and 6 months in favor of IM nail fixation. There were no statistically significant differences in complications, including the number of postoperative infections (13% in the locking plate group and 9% in the IM nail fixation group).
- Further surgery was more common in the locking plate group (12% in locking plate group and 8% in IM nail fixation group at 12 months).
- The economic evaluation showed that IM nail fixation provided a slightly higher quality of life in the 12 months after injury and at lower cost and, therefore, it was cost-effective compared with locking plate fixation.
- The probability of cost-effectiveness for IM nail fixation exceeded 90%, regardless of the value of the cost-effectiveness threshold.
The study concluded that among adults with an acute fracture of the distal tibia who were randomized to IM nail fixation or locking plate fixation, there were similar disability ratings at 6 months. However, recovery across all outcomes was faster in the IM nail fixation group and costs were lower.
For more reference log on to https://doi.org/10.3310/hta22250
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