Evaluation of Patient-Reported Outcome Measures in Patients Receiving Bio-Integrative Screws for Lisfranc Injuries: A Case Series Study

Abstract

Category: Midfoot/Forefoot; Midfoot/Forefoot Introduction/Purpose: Lisfranc injury consists of a spectrum of injuries affecting the tarsometatarsal joint. Various fixation methods are used to treat Lisfranc injuries and each show different outcomes. Metal implants have been used for open reduction and internal fixation (ORIF) of Lisfranc injuries routinely. However, other than the complications in these patients, such as non- anatomical reduction, implant loosening, breakage, and arthrosis, most of these patients will undergo a second surgery for implant removal. Using bio-degradable and bio-integrative materials in these implants reduces the need for these re-operations; however, whether other complications reported for metal implants occur by using bio-integrative materials has yet to be proven. The aim of our study is to assess patient-reported outcome measures (PROMs) and complications in patients received bio-integrative screws for Lisfranc fixation. Methods: The inclusion criteria were 1) ≥ 18 years old, and 2) had ORIF for Lisfranc injury using bio-integrative (OSSIOfiber ™) screws. The patients’ charts were reviewed, and the variables were gathered, including the type of injury, pain score, and PROMs. The questionnaires used to evaluate PROMs were Patient-Reported Outcome Measurement Information System (PROMIS) surveys for physical function, pain interference, pain intensity, and depression. We also reported the average scores for these PROMs among a randomly sampled population of patients who had ORIF with metal screws for Lisfranc injuries for comparison (n=12). Results: We recruited 12 patients for this study. The minimum follow-up time of the patients in this study was three months. Out of 12 patients, 1 patient showed non-union. The mean (SD) PROMIS scores for physical function, pain interference, pain intensity, and depression were 43.9 (14.9), 56.1 (13.9), 45.9 (10.1), and 43.5 (4.9) in patients who received bio-integrative screws, respectively. In the sampled population treated with metal screws, these PROMs were 42.1 (9.5), 55 (10.1), 46.4 (8.1), and 44.4 (6.4) for physical function, pain interference, pain intensity, and depression, respectively. No significant difference was observed between the two groups regarding physical function (P=0.72), pain interference (P0.82), pain intensity (P=0.88), and depression (P=0.69). Conclusion: The current report showed promising patient-reported outcomes after Lisfranc ORIF with bio-integrative screws. However, longer term follow-ups, as well as comparison with a larger population for both types of instruments, bio-integrative and metal, will shed light on the pros and cons of both materials. Moreover, cost-effective studies are highly suggested to assess the usefulness of these implants against their costs for the healthcare system and the patients.