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Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia: The UK FixDT Randomized Clinical Trial.

ABSTRACT: Importance:The best treatment for fractures of the distal tibia remains controversial. Most such fractures require surgical fixation but outcomes are unpredictable and complications are common. Objective:To assess disability, quality of life, and complications in patients with displaced tibial fracture treated with intramedullary nail fixation vs locking plate fixation. Design, Setting, and Participants:A multicenter randomized trial recruiting 321 patients 16 years or older with an acute, displaced, extra-articular fracture of the distal tibia from April 2013 through April 2016 with final follow-up in February 2017. Exclusion criteria included open fractures, fractures involving the ankle joint, contraindication to nailing, or inability to complete questionnaires. Interventions:Intramedullary nail fixation (nail group; n?=?161), a metal rod inserted into the hollow center of the tibia, vs locking plate fixation (plate group; n?=?160), a plate attached to the surface of the tibia with fixed-angle screws. Main Outcomes and Measures:Disability Rating Index (DRI; score range, 0 [no disability] to 100 [complete disability]) at 6 months was the primary outcome measure, with a minimal clinically important difference of 8 points. DRI measurement was also collected at 3 and 12 months. Secondary outcomes were the Olerud-Molander Ankle Score (OMAS), quality of life, and complications (such as infection and further surgery). Results:Among 321 randomized patients (mean age, 45 years [SD, 16.2]; men, 197 [61%]; had experienced traumatic injury after a fall, 223 [69%]), 258 completed the study. There was no statistically significant difference in the DRI score at 6 months between groups (mean score, 29.8 in the nail group vs 33.8 in the plate group; adjusted difference, 4.0 [95% CI, -1.0 to 9.0], P?=?.11). There was a statistically significant difference in the DRI score at 3 months in favor of nail fixation (mean score, 44.2 in the nail group and 52.6 in the plate group; adjusted difference, 8.8 [95% CI, 4.3 to 13.2], P?

SUBMITTER: Costa ML

PROVIDER: S-EPMC5820712 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia: The UK FixDT Randomized Clinical Trial.

Costa Matthew L ML Achten Juul J Griffin James J Petrou Stavros S Pallister Ian I Lamb Sarah E SE Parsons Nick R NR

JAMA 20171101 18

<h4>Importance</h4>The best treatment for fractures of the distal tibia remains controversial. Most such fractures require surgical fixation but outcomes are unpredictable and complications are common.<h4>Objective</h4>To assess disability, quality of life, and complications in patients with displaced tibial fracture treated with intramedullary nail fixation vs locking plate fixation.<h4>Design, setting, and participants</h4>A multicenter randomized trial recruiting 321 patients 16 years or olde ...[more]

PMID: 29136444

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Project description:The use of low-profile dorsal and volar locking plates for distal radial fracture surgery has improved results and lowered the complication rate compared with older plate designs. The purpose of the present randomized controlled trial was to compare patient-reported outcomes as well as radiographic and functional results between patients who underwent stabilization with a volar locking plate or a dorsal locking nail-plate for the treatment of dorsally displaced unstable extra-articular distal radial fractures. One hundred and twenty patients ≥55 years of age were randomized to surgery with either a volar locking plate or a dorsal locking nail-plate and were assessed at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. The primary outcome was the abbreviated version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score. Secondary outcomes were the Patient-Rated Wrist Evaluation (PRWE), EuroQol 5 Dimensions (EQ-5D) index and visual analog scale (VAS), range of motion, grip strength, radiographic measurements, and complication rate. The median age was 66 years (range, 55 to 88 years). The rate of follow-up was 97%. There was no clinically important difference between the groups at any point during follow-up. Patients in the volar locking plate group had better mean QuickDASH scores at 6 weeks, 6 months, and 1 year. However, the differences were small (5.8 vs. 11.3 points at 1 year; mean difference, -5.5 points [95% confidence interval (CI), -9.9 to 1.2]; p = 0.014), which is lower than any proposed minimum clinically important difference (MCID). The difference in PRWE scores was also lower than the MCID (1.0 vs. 3.5 at 1 year; mean difference, -2.5 [95% CI, -4.4 to 0.6]; p = 0.012). The dorsal locking nail-plate group had slightly better restoration of volar tilt (p = 0.011). EQ-5D index, EQ-5D VAS, range of motion, grip strength, and complication rates were similar. We found no clinically relevant difference between the volar locking plate and dorsal locking nail-plate groups after 1 year or in the time period up to 1 year. A dorsal locking nail-plate can therefore be an alternative method for the treatment of these unstable fractures or in cases in which a dorsal approach is preferable over a volar approach. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:ObjectivesTo compare the clinical effectiveness of Kirschner wire fixation with locking plate fixation for patients with a dorsally displaced fracture of the distal radius.DesignA multicentre two arm parallel group assessor blind randomised controlled trial with 1:1 treatment allocation.Setting18 trauma centres in the United Kingdom.Participants461 adults with a dorsally displaced fracture of the distal radius within 3 cm of the radiocarpal joint that required surgical fixation. Patients were excluded if the surgeon thought that the surface of the wrist joint was so badly displaced it required open reduction.InterventionsKirschner wire fixation: wires are passed through the skin over the dorsal aspect of the distal radius and into the bone to hold the fracture in the correct anatomical position. Locking plate fixation: a locking plate is applied through an incision over the volar (palm) aspect of the wrist and secured to the bone with fixed angle locking screws.Main outcome measuresPrimary outcome measurevalidated patient rated wrist evaluation (PRWE). This rates wrist function in two (equally weighted) sections concerning the patient's experience of pain and disability to give a score out of 100.Secondary outcomesdisabilities of arm, shoulder, and hand (DASH) score, the EuroQol (EQ-5D), and complications related to the surgery.ResultsThe baseline characteristics of the two groups were well balanced, and over 90% of patients completed follow-up. The wrist function of both groups of patients improved by 12 months. There was no clinically relevant difference in the patient rated wrist score at three, six, or 12 months (difference in favour of the plate group was -1.3, 95% confidence interval -4.5 to 1.8; P=0.40). Nor was there a clinically relevant difference in health related quality of life or the number of complications in each group.ConclusionsContrary to the existing literature, and against the rapidly increasing use of locking plate fixation, this trial found no difference in functional outcome in patients with dorsally displaced fractures of the distal radius treated with Kirschner wires or volar locking plates. Kirschner wire fixation, however, is cheaper and quicker to perform.Trial registrationCurrent Controlled Trials ISCRTN 31379280. UKCRN 8956.

Project description:ObjectiveThe treatment of distal third humeral shaft fracture is difficult. Studies have shown that anterior minimally invasive plate has lower probability of complication and higher healing rate. However there is no applicable anatomical plate at present. This study is to investigate the clinical effect of intramedullary nail combined with anterior minimally invasive plate in the treatment of distal humeral shaft fractures.MethodsThe data of 83 patients with lower humerus shaft fracture treated from September 2015 to January 2020 were analyzed. According to different treatment methods, they were divided into two groups: 40 patients were treated with intramedullary nailing combined with minimally invasive anterior plate fixation (group A), and 43 patients were treated with double plate fixation through posterior approach (group B). General preoperative data, operative time, intraoperative blood loss, total incision length, fracture healing time, shoulder and elbow visual analogue scale (VAS) score, Constant-Murley shoulder function score, Mayo elbow function score, and complications were recorded and compared between the two groups. Two independent sample t-tests was used for follow-up, age, BMI, operation time, intraoperative bleeding, total incision length, fracture healing time, Constant-Murley score and Mayo score, and rank sum test was used for VAS score of shoulder and elbow.ResultsThere was no significant difference in preoperative general data between the two groups (p > 0.05), indicating comparability. There were no significant differences in operation time, total incision length, fracture healing time, Constant-Murley shoulder function score at the last follow-up, Mayo elbow function score, and shoulder and elbow VAS pain score between 2 groups (p > 0.05). The amount of intraoperative blood loss in observation group was 76.98 ± 16.46, which was significantly less than that in control group, and the difference was statistically significant (p < 0.01). There were no radial nerve injury, musculocutaneous nerve injury, incision infection and fracture nonunion in the observation group. In the control group, four cases of iatrogenic radial nerve injury, three cases of incision infection and three cases of fracture nonunion were found. The complication rate was 23.3% (10/43). There was statistical difference in the incidence of complications between the two groups (p < 0.01).ConclusionA humeral intramedullary nail combined with an anterior minimally invasive plate in the treatment of distal humeral shaft fracture has the advantages of less soft tissue damage, less blood transfusion, high fracture healing rate and low risk of iatrogenic radial nerve injury, which is an effective method for clinical treatment of this type of fracture.

Dataset Information

Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia: The UK FixDT Randomized Clinical Trial.

Publications

Effect of Locking Plate Fixation vs Intramedullary Nail Fixation on 6-Month Disability Among Adults With Displaced Fracture of the Distal Tibia: The UK FixDT Randomized Clinical Trial.

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