Dataset Information

The benefits of hardware removal in patients with pain or discomfort after fracture healing of the ankle: a systematic review protocol.

ABSTRACT:

Introduction

For any orthopaedic surgeon working with trauma; ankle fractures are one of the most common injuries treated. The treatment of ankle fractures can be conservative, using external fixation, but more commonly the fractures are treated with open reduction and internal fixation. Residual pain and discomfort are common in patients after surgical treatment of fractures of the ankle. Sometimes it is difficult to determine whether the pain or discomfort is due to the implants left in situ or the primary injury itself. In many cases, the decision is made to remove the implants. Extraction of internal fixation material from the ankle is a common procedure in many orthopaedic clinics. There are no evidence-based guidelines or consensus regarding the effect of hardware removal from the ankle. The aim of this protocol is to describe the method that will be used to collect, describe and analyse the current evidence regarding hardware removal after fracture healing of the ankle.

Methods and analysis

We will conduct a systematic review of studies that were published after 1967 regarding the benefits of hardware removal in patients with pain or discomfort after fracture healing of the ankle. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. We will make a predefined search strategy and use it in several databases. We will include both randomised controlled trials (RCTs) and non-RCT studies. We will use descriptive statistics to summarise the studies collected. If more than one RCT is collected then a meta-analysis will be conducted. The quality of evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation guidelines.

Ethics and dissemination

No ethics approval is required as no primary data will be collected. Once complete, the results will be made available by peer-reviewed publication.

Trial registration number

PROSPERO registration number CRD42016039186.

SUBMITTER: Thune A

PROVIDER: S-EPMC5724201 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Publications

The benefits of hardware removal in patients with pain or discomfort after fracture healing of the ankle: a systematic review protocol.

Thune Alexandra A Hagelberg Mårten M Nåsell Hans H Sköldenberg Olof O

BMJ open 20170811 8

<h4>Introduction</h4>For any orthopaedic surgeon working with trauma; ankle fractures are one of the most common injuries treated. The treatment of ankle fractures can be conservative, using external fixation, but more commonly the fractures are treated with open reduction and internal fixation. Residual pain and discomfort are common in patients after surgical treatment of fractures of the ankle. Sometimes it is difficult to determine whether the pain or discomfort is due to the implants left i ...[more]

PMID: 28801390

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Project description:BackgroundAnkle fractures are among the most common physeal fractures in children. When surgical management is warranted, subsequent hardware removal remains controversial. This study was designed to determine rates of hardware removal in patients with physeal ankle fractures and identify risk factors for removal. Procedure data was utilized to compare rates of subsequent ankle procedures in patients with hardware removed and hardware retained.MethodsWe conducted a retrospective cohort study utilizing data from the Pediatric Health Information System (PHIS) for the years 2015 through 2021. We longitudinally followed patients treated for distal tibia physeal fractures to determine the rates of hardware removal and subsequent ankle procedures. Patients with open fractures or polytrauma were excluded. We used univariate, multivariate, and descriptive statistics to characterize the rates of hardware removal, identify factors associated with removal, and assess the rates of subsequent procedures.ResultsThis study included 1008 patients who underwent surgical management of a physeal ankle fracture. The mean age at index surgery was 12.6 years with an SD of 2.2 years, and 60% of patients identified as male. Two hundred forty-two patients (24%) had their hardware removed at an average time of 276 days (range, 21-1435 days) following index surgery. Patients with Salter Harris III (SH-III) or Salter Harris IV (SH-IV) fractures had hardware removed more often than patients with Salter-Harris II (SH-II) fractures (28.9% vs 11.7%, P < .01). Four-year rates of subsequent ankle procedures are similar between patients with hardware removed and hardware retained.ConclusionThe rate of hardware removal in children with physeal ankle fractures is higher than previously reported. Patients of younger age, higher income, and with fractures involving the epiphysis (SH-III and SH-IV) are more likely to undergo hardware removal.Level of evidenceLevel III, retrospective study.

Project description:IntroductionAnkle fracture surgery is a common procedure, but the influence of anaesthesia choice on postoperative pain and quality of recovery is poorly understood. Some authors suggest a benefit of peripheral nerve block (PNB) in elective procedures, but the different pain profile following acute fracture surgery and the rebound pain on cessation of the PNB both remain unexplored. We present an ongoing randomised study aiming to compare primary PNB anaesthesia with spinal anaesthesia for ankle fracture surgery regarding postoperative pain profiles and quality of recovery.Methods and analysisAnAnkle Trial is a randomised, dual-centre, open-label, blinded analysis trial of 150 adult patients undergoing primary internal fixation of an ankle fracture. Main exclusion criteria are habitual opioid use, impaired pain sensation, other painful injuries or cognitive impairment. The intervention is ultrasound-guided popliteal sciatic (20 mL) and saphenal nerve (8 mL) PNB with ropivacaine 7.5 mg/mL, and controls receive spinal anaesthesia (2 mL) with hyperbaric bupivacaine 5 mg/mL. Postoperatively all receive paracetamol, ibuprofen and patient-controlled intravenous morphine on demand. Morphine consumption and pain scores are registered in the first 27 hours and reported as an integrated pain score as the primary endpoint. Pain score intervals are 3 hours and we will use the area under curve to get a longitudinal measure of pain. Secondary outcomes include rebound pain on cessation of anaesthesia, opioid side effects (Opioid-Related Symptom Distress Scale), quality of recovery (Danish Quality of Recovery-15 score) and pain scores and medication days 1-7 (diary).Ethics and disseminationThe study has been approved by the Regional Ethics Committees in the Capital Region of Denmark, the Danish Data Protection Agency and the Danish Health and Medical Authority. We will publish the results in international peer-reviewed medical journals.Trial registration numberAnAnkle Trial is registered in the European Clinical Trials Database (EudraCT 2015-001108-76).

Project description:BackgroundThe investigation of nonnarcotic drug regimens for postoperative pain management is important in addressing the opioid epidemic. NSAIDs can be a powerful adjunct in managing postoperative pain, but the possibility of delayed bone healing is a major concern for orthopaedic surgeons. Our recent retrospective study on ketorolac administration demonstrated that the NSAID is not associated with an increased risk of delayed union or nonunion after ankle fracture surgery.Questions/purposesTo determine whether postoperative ketorolac (1) reduces opioid consumption, (2) improves VAS pain control, and (3) affects fracture healing after open reduction and internal fixation of ankle fractures.MethodsBetween August 2016 and December 2017, 128 patients undergoing open reduction and internal fixation of an acute ankle fracture were randomized before surgery via simple randomization to treatment with or without ketorolac. No patients changed treatment regimen groups or opted out of randomization. All other aspects of perioperative care were treated identically. A once-daily survey was distributed via email on postoperative Days 1 to 7. Unblinded participants were asked to report their daily opioid consumption, pain level, and sleep interference using the VAS, and pain frequency using a five-point Likert scale, and side effects with the VAS. For VAS pain, > 20 mm/100 mm on the VAS scale was required to be considered "improved." In all, 83% (106 of 128) patients completed all seven postoperative surveys with 14 in the control group and eight in the ketorolac group lost to follow-up. Fifty-six patients were administered ketorolac with opioid medication (treatment group) and 50 were administered opioids alone (control group). Participants were comprised of 42% men (44), and 58% women (62); mean age was 48 years. The treating surgeon assessed clinical healing based on the patient's ability to ambulate comfortably at 12 weeks postoperatively. Radiographic healing was assessed by two fellowship-trained orthopaedic foot and ankle surgeons blinded to the patient's name and time since surgery. The surgeons evaluated randomized standard ankle series (anteroposterior, mortise, and lateral) radiographs for resolution of each fracture line to determine fracture union, with delayed union being defined as fracture lines present on radiographs taken at 12-week postoperative visits. Intention-to-treat analysis was performed.ResultsPatients in the treatment group consumed a mean of 14 opioid pills, which was less than the mean of 19.3 opioids pills consumed by patients in the control group (p = 0.037). Patients with ketorolac had lower median VAS scores for pain (p < 0.035) postoperatively on postoperative Days 1 and 2 than did control patients. By contrast, patient-reported pain scores and scores for sleep did not convincingly show a benefit to the use of ketorolac. For patients whose ankle fractures healed at 12 weeks, there was no difference between the groups in terms of clinical healing (p = 0.575) and radiographic healing (p = 0.961).ConclusionsIn this randomized study, adding ketorolac to the postoperative drug regimen decreased the use of opioid medication after open reduction and internal fixation of ankle fractures in the early postoperative period, and there were mixed, small effects on pain reduction. This NSAID is a valuable tool in helping patients manage postoperative pain with less use of narcotic analgesia. However, our study was underpowered to determine the true safety of this drug in terms of fracture healing and side effects and these questions warrant higher-powered randomized study investigation.Level of evidenceLevel I, therapeutic study.

Dataset Information

The benefits of hardware removal in patients with pain or discomfort after fracture healing of the ankle: a systematic review protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

The benefits of hardware removal in patients with pain or discomfort after fracture healing of the ankle: a systematic review protocol.

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