Evaluation of the efficacy of salmon calcitonin nasal spray on bone healing following open reduction and internal fixation of mandibular fractures — A randomized controlled trial

Author(s):  
Aritra Roy ◽  
Selvakumar Thulasiraman ◽  
Elavenil Panneerselvam ◽  
Guruprasad Thulasi Doss ◽  
Mary Nancy Selvaraj ◽  
...  
2021 ◽  
Vol 103-B (6) ◽  
pp. 1040-1046
Author(s):  
Edward J. Dickenson ◽  
Nick Parsons ◽  
Damian R. Griffin

Aims We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial. Methods HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months. Results Overall, 60-month outcome data were available for 118 patients (78%; 52 ORIF, 66 nonoperative). After 60 months, mean Kerr-Atkins scores were 79.2 (SD 21.5) for ORIF and 76.4 (SD 22.5) for nonoperative. Mixed effects regression analysis gave an estimated effect size of -0.14 points (95% confidence interval -8.87 to 8.59; p = 0.975) in favour of ORIF. There were no between group differences in difficulty walking (p = 0.175), or on the type of shoes worn (p = 0.432) at 60 months. Additional surgical procedures were conducted on ten participants allocated ORIF, compared to four in the nonoperative group (p = 0.043). Conclusion ORIF of displaced intra-articular calcaneal fractures, not causing fibular impingement, showed no difference in outcomes at 60 months compared to nonoperative treatment, but with an increased risk of additional surgery. Cite this article: Bone Joint J 2021;103-B(6):1040–1046.


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