IntraMedullary nailing Versus EXternal ring fixation for the treatment of tibial shaft fractures (IMVEX): a multicentre randomized controlled clinical trial.

• DOI: 10.1302/0301-620x.107b3.bjj-2024-0812.r1
• Publication Date: 2025-03-01
• Authors: Rasmus Stokholm; Peter Larsen; Jan Duedal Rölfing; Juozas Petruskevi...; Morten Kjerri Ras...; Steffen Skov Jensen; Rasmus Elsøe

One of the most common patient-reported complaints following intramedullary nailing (IMN) tibial shaft fractures is anterior knee pain reported by 10% to 80% patients. The present study aimed compare 12-month Knee injury and Osteoarthritis Outcome Score (KOOS) sport recreation activities subscale (sport/rec) scores after IMN with external ring fixation (RF) adult patients fractures. This was a pragmatic multicentre randomized, non-blinded trial, two-group parallel design. Included were (aged ≥ 18 years) presenting an acute fracture deemed operable nail. primary outcome KOOS sport/rec, ranging from 0 (worst score) 100 (best at follow-up. Secondary outcomes included Foot Ankle (FAOS), health-related quality life assessed EuroQol five-dimension five-level health questionnaire, scores. A total 67 in study. In all, 33 randomized standard 34 RF. mean age 47.7 years (SD 19.2; 84) 34% female (n = 23). analysis revealed no statistically significant difference sport/rec between RF groups follow-up (adjusted -18.1 (95 % CI -43.4 7.2); favouring RF). No differences observed However, these results should be interpreted caution, due high risk type II error.