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Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial - study protocol.

ABSTRACT: BACKGROUND:Lisfranc injuries are known to be rare and often overlooked injuries that can cause long-term disability and pain when missed or treated incorrectly. The wide variety of Lisfranc injuries ranges from subtle ligament distensions to open fracture dislocations. The treatment of Lisfranc joint injuries is still controversial and very little is known about what types of injury can be treated nonoperatively. The current literature provides only two randomized studies on dislocated Lisfranc injuries. These studies have shown that primary arthrodesis (PA) leads to a similar or better outcome and results in fewer secondary operations when compared with open reduction and internal fixation (ORIF) in ligamentous injuries. There have been no previous randomized studies of the nonoperative versus operative treatment of Lisfranc injuries. Therefore, the purpose of this study is to compare the operative and nonoperative treatment of non-dislocated Lisfranc injuries and to compare the ORIF and PA treatment of dislocated Lisfranc injuries. METHODS:This study is a prospective, randomized, national multi-center trial. The trial comprises two strata: Stratum I compares cast-immobilization versus open reduction and internal fixation (ORIF) treatment of non-dislocated Lisfranc joint injuries. Stratum II compares PA versus ORIF in the treatment of dislocated injuries of the Lisfranc joint. The main hypothesis of stratum I is that the nonoperative treatment of non-dislocated Lisfranc injuries achieves a similar outcome compared with operative treatment (ORIF). The hypothesis of stratum II is that PA of dislocated Lisfranc injuries yields a similar functional outcome compared with ORIF, but that PA results in fewer secondary operations than ORIF. The main outcome measure is the American Orthopaedic Foot and Ankle Society (AOFAS) Midfoot score and the secondary outcome measures are Visual-Analogue-Scale Foot and Ankle (VAS-FA), Visual-Analogue-Scale (VAS), rate of secondary operations and other treatment-related complications. The results will be analyzed after the 2-year follow-up period. DISCUSSION:This publication presents a prospective, randomized, national multi-center trial study protocol. It provides details of patient flow, randomization, aftercare and methods of analysis of the material and ways to present and publish the results. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02953067 24.10.2016.

SUBMITTER: Ponkilainen VT

PROVIDER: S-EPMC6102864 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial - study protocol.

Ponkilainen Ville T VT Mattila Ville M VM Laine Heikki-Jussi HJ Paakkala Antti A Mäenpää Heikki M HM Haapasalo Heidi H HH

BMC musculoskeletal disorders 20180821 1

<h4>Background</h4>Lisfranc injuries are known to be rare and often overlooked injuries that can cause long-term disability and pain when missed or treated incorrectly. The wide variety of Lisfranc injuries ranges from subtle ligament distensions to open fracture dislocations. The treatment of Lisfranc joint injuries is still controversial and very little is known about what types of injury can be treated nonoperatively. The current literature provides only two randomized studies on dislocated L ...[more]

PMID: 30126393

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Project description:BackgroundThe Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture dislocation, treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation. The purpose of the proposed study is to define the optimal treatment for the Lisfranc fracture dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to quality of life, complications, functional outcomes, and cost effectiveness.MethodsStudy design: A prospective multicenter RCT.Study populationAll patients of 18 years and older with an acute (< 6 weeks) traumatic fracture dislocation in the Lisfranc midfoot joints, displaced on static radiographic evaluation or unstable with dynamic evaluation, weight bearing radiographs or fluoroscopic stress testing under anesthesia, and eligible for either one of the surgical procedures. In total, this study will include n = 112 patients with Lisfranc fracture dislocation.InterventionsPatients with Lisfranc fracture dislocation will be randomly allocated to treatment in "The Better to Fix or Fuse Study" (The BFF Study) with either PA or ORIF. Main study parameters/endpoints: Primary outcome parameter: the quality of life.Secondary outcomescomplications, functional outcomes, secondary surgical interventions and cost effectiveness. Nature and extent of the burden: PA is expected to have a better outcome, however both treatments are accepted for this injury with a similar low risk of complications. Follow up is standardized and therefore this study will not add extra burden to the patient.DiscussionThis study protocol provides a comprehensive overview of the aims and methods of the attached clinical study. Limitations of this study are the absence of patient blinding since it is impossible in surgical intervention, and the outcome measure (AOFAS) that has limited validity not for these injuries. This study will be the first with enough power to define optimal treatment for Lisfranc fracture dislocations. This is necessary since current literature is unclear on this topic. Trial registration Current controlled Trial: NCT04519242 with registration date: 08/13/2020. Retrospectively registered; Protocol date and version: Version 4 05/06/2020.

Project description:BackgroundOpen reduction and plate fixation are the preferred treatment options for most distal humerus fractures in adults. However, it is often challenging for orthopedic surgeons because of the complex anatomy and the difficulty in achieving stable fixation. This multicenter study aimed to analyze the complication types and rates of patients with distal humerus fractures treated with open reduction and plate fixation, and compare the results with those found in the literature. In addition, we describe the clinical outcomes.MethodsThis retrospective multicenter study was conducted between September 2001 and March 2021 and included data from four hospitals. In total, 349 elbows underwent surgical treatment at these hospitals during the study period. Patients > 17 years of age who were treated by plate fixation were included, and patients who were treated by other fixation methods were excluded. A total of 170 patients were included in the study. The following types of complications were investigated: (1) nerve related; (2) fixation and instrument related; (3) osteosynthesis related; (4) infection; and (5) others.ResultsThe following complications were found: (1) 26 (15.3%) cases of postoperative ulnar nerve symptoms; 4 (2.4%) of postoperative radial nerve symptoms; (2) one (0.6%) case of screw joint penetration and screw loosening; and eight (4.7%) cases of hardware removal due to instrument skin irritation; (3) seven (4.1%) cases of nonunion; (4) two (1.2%) and four (2.2%) cases of superficial and deep infection, respectively, and seven (3.9%) cases of wound complication; and (5) 37 (21.8%) cases of heterotrophic ossification, 79 (46.5%) cases of elbow stiffness (did not achieve functional range of motion [ROM]), and 41 (24.1%) cases of osteoarthritis over Broberg and Morrey Grade I. Paradoxically, the postoperative ulnar nerve symptoms were more frequent in the prophylactic ulnar nerve anterior transposition group. However, this difference was not statistically significant (p = 0.086). The mean ROM was 123.5° flexion to 9.5° extension. The average Disabilities of the Arm, Shoulder and Hand (DASH) score was 14.5 ± 15.6.ConclusionsOpen reduction and plate fixation for distal humeral fractures is a reasonable treatment option with acceptable complication rates and favorable clinical outcomes. Surgeons must be vigilant about ulnar nerve complications. Level of Evidence Therapeutic Level III.

Project description:BackgroundProximal humerus fractures treated in the face of ipsilateral injuries to the shoulder girdle may be predisposed to worse clinical outcomes.Questions/purposesThe purpose of this investigation was to examine outcomes of proximal humerus fractures treated with open reduction internal fixation (ORIF) using an endosteal augment in the presence of a concomitant shoulder girdle injury in comparison to isolated proximal humerus fractures treated with ORIF and endosteal augment.MethodsA prospective database was used to identify proximal humerus fractures with ipsilateral shoulder girdle injuries (glenohumeral and acromioclavicular dislocation, fractures of the acromion, clavicle, scapula, or humeral diaphysis). These were compared to isolated proximal humerus fractures treated in the same fashion (ORIF with endosteal augment). Minimum of 1 year follow-up was required for inclusion. Outcomes assessed included range of motion (ROM), development of avascular necrosis (AVN), hardware-related complications, reoperation, and subjective outcome assessments including the Disabilities of Arm Shoulder and Hand questionnaire (DASH), Constant score, UCLA rating scale, and the Short Form-36 (SF-36).ResultsFifteen ipsilateral injuries were seen in 14 patients. Seventy-seven isolated proximal humerus fractures were available for comparison. The ipsilateral injury group had significantly worse forward flexion (141 vs 156°, p = 0.02), external rotation (56 vs 64°, p = 0.03), higher rates of avascular necrosis (4 of 14, 28.6% vs 1 of 77, 1.3%, p = 0.002), and inferior SF-36 physical health scores (48.5 vs 63.5; p = .04). Despite these differences, no significant differences were seen with hardware-related complications or DASH, Constant score, or UCLA rating scale results. No patients required secondary reconstructive procedures.ConclusionDespite a statistically higher rate of AVN and decreased ROM, patient-based outcomes of proximal humerus fractures with ipsilateral shoulder injuries approached those seen in isolated proximal humerus fractures. This suggests that these injuries can achieve similarly good clinical results provided any associated shoulder pathology is identified and treated appropriately.

Project description:BackgroundUnstable Lisfranc injuries are best treated with anatomic reduction and stable fixation. There are controversies regarding which type of stabilization is best. In the present study, we compared primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating in unstable Lisfranc injuries.MethodsForty-eight patients with Lisfranc injuries were included and followed for 2 years. Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients were randomized to temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints. The main outcome parameter was the American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale and the secondary outcome parameters were the 36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain). Computed tomography (CT) scans pre- and postoperatively were obtained. Radiographs were obtained at follow-ups. Pedobarographic examination was performed at the 2-year follow-up. Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up.ResultsThe mean AOFAS midfoot score 2 years postoperatively was 89 (SD 9) in the PA group and 85 (SD 15) in the BP group (P = .32). There were no significant differences between the groups with regard to SF-36 or VAS pain scores. The alignment of the first metatarsal was better in the BP group than in the PA group measured by the anteroposterior Meary angle (P = .04). The PA group had a reduced peak pressure under the fifth metatarsal (P = .047). In the BP group, 11/24 patients had radiologic signs of osteoarthritis in the first TMT joint.ConclusionBoth treatment groups had good outcome scores. The first metatarsal was better aligned in the BP group; however, there was a high incidence of radiographic osteoarthritis in this group.Level of evidenceTherapeutic level I, prospective randomized controlled study.

Project description:BACKGROUND:Proximal humerus fractures are the third most common fracture in the elderly population and are expected to increase due to the aging population. Surgical fixation with locking plate technology has increased over the last decade despite a lack of proven superiority in the literature. Three previous randomized controlled trials have not shown a difference in patient-centered outcomes when comparing non-operative treatment with open reduction and internal fixation. Low patient enrollment and other methodological concerns however limit the generalizability of these conclusions and as a result, management of these fractures remains a controversy. By comparing the functional outcomes of locked plate surgical fixation versus non-operative treatment of displaced three and four-part proximal humerus fractures in the elderly population with a large scale, prospective, multi-centered randomized controlled trial, the optimal management strategy for this common injury may be determined. METHODS:We will conduct a prospective, single blind randomized controlled parallel arm trial to compare non-operative management of proximal humerus fractures with open reduction and internal fixation using locked plating technology. One-hundred and sixty patients > age 60 with acute 3- or 4- part proximal humerus fractures will be randomized to either open reduction and internal fixation with locked plating technology or non-operative management treatment arms. The primary outcome measure is the Constant Score at 24 months post-operative. Secondary outcome measures include the American Shoulder and Elbow Surgeon's Score (ASES), EuroQol EQ-5D-5 L Health Questionnaire Score, short form PROMIS upper extremity score and IPAQ for the elderly score. Further outcome measures include assessment of the initial classification, displacement and angulation and the quality of surgical reduction via a standard computed tomography (CT) scan; rates of non-union, malunion, arthrosis, osteopenia or other complications including infection, nerve injury, intra-articular screw penetration, reoperation rates and hospital re-admission rates. DISCUSSION:The results of this trial will provide Level 1 evidence to guide decision-making in the treatment of proximal humerus fractures in the elderly population. TRIAL REGISTRATION:ClinicalTrials.gov NCT02362100 . Registered 5 Feb 2015.

Dataset Information

Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial - study protocol.

Publications

Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial - study protocol.

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