Off-label use and prescribing: what does it mean for the foot and ankle surgeon?

Drugs and medical devices obtain specific on-label indications for use by the Food and Drug Administration. Physicians are able to use such devices and drugs off label as part of the practice of medicine, but is this is good thing? This edition of In the Profession examines what it means to be off label in terms of regulations, clinical studies, industry marketing, and common areas of use.     

Surgical clerkship or medical clerkship first: Does it make a difference?

Introduction

This study compares NBME surgical clerkship scores of students who completed their medicine clerkship before their surgical clerkship with the performance of those who had not previously completed their medical clerkship.

Neuromuscular monitoring: does it make a difference?

Purpose

The objective of the present prospective study was to evaluate the influence of neuromuscular monitoring. on the level of neuromuscular blockade from induction of anaesthesia until extubdtion of the trachea.

Methods

Forty-two patients aged between 18 and 73 yr undergoing a range of surgical procedures under general anaesthesia were randomly distributed into two groups of 21 patients each. In both groups a Datex NMT Monitor® was used and electromyographic responses of the the ulnar muscles to supramaximal stimulation of the ulnar nerve were recorded. In Group 1, the anaesthetist could see the movements of the stimulated hand, but not the monitor. In Group 2, the anaesthetist could see neither the stimulated hand nor the monitor. The same anaesthetist administered the neuromuscular relaxants which were succinylcholine 1.5 mg · kg^?1 for trachéal intubation and vecuronium 0.1 mg· kg^?1 for neuromuscular relaxation during surgery, followed by 1 to 2 mg maintenance injections. Possible residual curarization was evaluated in the recovery room by head lift tests and pulse oximetry.

Results

Patients in Group 1 had deeper neuromuscular block throughout surgery, despite the use of a comparable dose of vecuronium (10.1 mg for G1 vs 11.2 mg for G2). The EMG values of T₁ and train-of-four values were not different at trachéal intubation or at extubation. No patients presented signs of residual curarization in the recovery room.

Conclusion

The study demonstrates that with the same amount of vecuronium the neuromuscular relaxation was deeper with the use of a simple neuromuscular monitoring (visual evaluation of the thumb movements). Despite the deeper neuromuscular block in the monitored group, there was no residual curarization in the recovery room.     

Early leukocytosis in trauma patients: what difference does it make?

OBJECTIVE: To determine the association of the admission white blood cell count in trauma patients with demographics, severity and mechanism of injury, and need for therapeutic intervention. METHODS: Evaluation of prospectively collected registry data (admissions to a Level I trauma center in 2001). Differences in mean white blood cell count on admission were evaluated with t tests. Multiple linear regressions were performed with forward stepwise selection of variables. RESULTS: Of the 882 patients admitted for greater than 24 hours, white blood cell count was available for 786. Variations in white blood cell count were noted on bivariate analysis among different races, injury mechanisms and severities, Glasgow Coma Scores, blood pressures, and between patients requiring early transfusions versus those who did not. No difference was noted between patients who went to the operating room in the first 24 hours versus those who did not, or for patients who died in the hospital. On multiple linear regression analyses, only ISS greater than 15, GCS less than or equal to 8, and white race were associated with increases in white blood cell count. Leukocytosis was found not to be associated with mechanism of injury, specific organ injury, shock on admission, or the need for transfusion or surgery. CONCLUSION: Variations in white blood cell count in trauma patients are associated with race and injury severity, but they are not beneficial in predicting the need for volume resuscitation, transfusion, or surgery.     

Intraoperative ultrasonography and surgical strategy in hepatic resection: What difference does it make?

Background

With modern advancements in preoperative imaging for liver surgery, intraoperative ultrasonography (IOUS) may be perceived as superfluous. Our aim was to determine if IOUS provides new information that changes surgical strategy in hepatic resection.

Methods

We retrospectively analyzed 121 consecutive liver resections performed at a single institution. Preoperative computed tomography and/or magnetic resonance imaging determined the initial surgical strategy. The size, location and number of lesions were compared between IOUS and preoperative imaging. Reviewing the operative report helped determine if new IOUS findings led to changes in surgical strategy. Pathology reports were analyzed for margins.

Results

Of 121 procedures analyzed, IOUS was used in 88. It changed the surgical plan in 15 (17%) cases. Additional tumours were detected in 10 (11%) patients. A change in tumour size and location were detected in 2 (2%) and 3 (4%) patients, respectively. Surgical plans were altered in 7 (8%) cases for reasons not related to IOUS. There was no significant difference (p = 0.74) in average margin length between the IOUS and non-IOUS groups (1.09 ± 1.18 cm v. 1.18 ± 1.05 cm).

Conclusion

Surgical strategy was altered owing to IOUS results in a substantial number of cases, and IOUS-guided resection planes resulted in R0 resections in nearly all procedures. The best operative plan in hepatic resection includes IOUS.     

Peer reviewing in foot and ankle surgery: is there a limit to scientific altruism?

IntroductionComplex foot and ankle trauma surgery is a super-specialization of orthopedic trauma surgery. This topic is gaining in interest, both clinically and in research. The peer review process is the cornerstone of the current scientific model of evaluation of research papers. The burden of peer review activity in foot and ankle trauma surgery is currently unknown.Material and methodA comprehensive Microsoft Outlook® analysis of over seven years’ worth of review invites from one surgical Foot & Ankle specialist working at a Level-1 trauma center was evaluated. The topic of each paper was recorded. Whether or not the journal was specifically foot ankle, orthopedic, general medicine or predatory of origin was noted. In addition, it was recorded if the journal was indexed in Pubmed, Medline, or Scopus. The topic of the paper was scored as being foot and ankle related, and more specifically foot and ankle trauma related. Review of revisions were scored as invites as well.ResultsFrom January 2013 to December 2019 a total of 467 review invites were received. The number of peer review invitations rose from 14 in 2013 to 127 in 2019. The percentage of foot and ankle specific journals was 27.4%. The number of requests from non-indexed (predatory) journals rose from 3.7% in 2014 to 36.2% in 2019, with a decrease in article topics related to the authors subspecialty. The annual absolute number of performed reviews stayed approximately the same throughout the study period (34 on average in the last 5 years).ConclusionThe number of review requests in foot and ankle surgery has increased about 5-fold over the 5 year period evaluated. There is a need for more reviewers to spread the burden. Therefore, foot and ankle specialists who are prepared to publish, should also be prepared to provide peer reviews to maintain a high level of quality in foot and ankle research.     

Language barriers and paediatric burns: Does education make a difference?

A focused first aid education campaign was conducted in Sydney in 1996 for parents of children from Non-English speaking backgrounds (NESB) to improve their knowledge of correct burns first aid treatment (BFAT). This study sought to determine the correlation, if any, between the reported beneficial results of this education campaign and the subsequent severity of burns in children. A retrospective review of all patients admitted to the state Burns Unit at The Children's Hospital at Westmead (CHW) over a 7-year period from January 1995 to December 2001 was performed. Number of patients, language spoken at home (English, Chinese, Arabic, Vietnamese or Other) and the rate of burns requiring skin grafting was assessed. A total of 1,283 patients were admitted over 7 years. Skin grafting was required in 544 (42%). NESB children required grafting in up to 88% of cases prior to the first aid education campaign, reducing to a minimum of 37% at 1 year and 65% at 5 years following the campaign. This compared to 40 and 36%, respectively, for English speaking children. While the initial decrease in grafting requirements may reflect an effective education campaign, the subsequent rise suggests the need for reinforcement.     

Narcotrend-assisted propofol/remifentanil anaesthesia vs clinical practice: does it make a difference?

BACKGROUND: The Narcotrend is a computer-based EEG monitor designed to measure the depth of anaesthesia. The aim of the present study is to test the hypothesis that the intraoperative level of anaesthetic depth differs if decision-making is guided by Narcotrend monitoring or not. METHODS: Forty-eight patients undergoing elective surgery were randomized to receive a Narcotrend-controlled propofol/remifentanil anaesthetic regimen or standard clinical practice. In the EEG group, anaesthesia was adjusted to achieve a Narcotrend level of D2-E0, which is recommended for moderate to deep anaesthetic depth for surgery. EEG values were recorded continuously every 20 s in both groups. Depending on data distribution, group comparisons of the EEG parameters, propofol plasma concentration, and recovery characteristics were performed by analysis of variance for repeated measurements or non-parametric statistics. RESULTS: About 62 (sd 29)% of the Narcotrend values were within the target level in the EEG group during maintenance of anaesthesia; this was true for 64 (26)% of the data in the non-EEG group. The variance of the Narcotrend data was significantly lower in the EEG group compared with the non-EEG group [median: 0.4 (range: 3.5) vs 0.6 (2.5); P = 0.048]. There was no difference in propofol or remifentanil dosage, propofol plasma concentrations, and time for extubation. Ten minutes after extubation, visual analogue scores for nausea indicated a lower incidence in the Narcotrend group [7 (15) vs 24 (34); P = 0.005]. CONCLUSIONS: Guidance of anaesthesia with the Narcotrend-monitor leads to fewer deviations from a defined target than clinical assessment of anaesthetic depth only. This results in lower scores of nausea in the immediate period after anaesthesia.     

Minimising negative ankle and foot X-rays in the Emergency Department—Are the Ottawa ankle rules good enough?

ObjectivesTo review fracture rates in patients who had X-rays of either the ankle or foot or both in the Emergency Department of a district hospital.MethodA retrospective review of 2589 Emergency Department patients who had X-rays of the ankle or foot or both over a 12-month period.ResultsThere were 1199 ankle X-rays taken of which 193 (16%) showed a significant fracture. There were 1081 patients who had a foot X-rayed of which 165 (15%) showed a significant fracture. Younger patients had more X-rays but older patients were more likely to have a fracture. There were 309 patients who had an ipsilateral ankle and foot X-rayed at the same time, and of these 42 (14%) showed one fracture and just two (0.6%) showed a significant fracture of both ankle and foot.ConclusionsThe approach to X-raying ankle and feet in this study is probably widespread, and Ottawa Ankle Rules still seem to be of limited use in diagnosing fractures. This low yield of positive X-ray could be accepted or a more sophisticated ankle rule introduced.     

Functional outcomes and clinical strength assessment after infraspinatus-sparing surgical approach to scapular fracture: Does it really make a difference?

Background

Surgical treatment of scapular fractures with posterior approach is frequently associated with postoperative infraspinatus hypotrophy and weakness. The aim of this retrospective study is to compare infraspinatus strength and functional outcomes in patients treated with the classic Judet versus modified Judet approach for scapular fracture.

Patients and methods

20 cases with scapular neck and body fracture treated with posterior approach for lateral border plate fixation were reviewed. In 11 of 20 cases, we used the modified Judet approach (MJ group), and in 9 cases we used the classic Judet approach (CJ group). All fractures were classified according to the AO classification system. At follow-up examinations, patients had X-ray assessment with acromiohumeral distance (AHD) measurement, clinical evaluation, active range of motion (ROM) examination, Constant Shoulder Score, and Disability of the Arm, Shoulder and Hand (DASH) Score. Infraspinatus strength assessment was measured using a dynamometer during infraspinatus strength test (IST) and infraspinatus scapular retraction test (ISRT).

Results

Demographic data did not significantly differ between the CJ group and MJ group, except for mean follow-up, which was 4.15 years in the CJ group and 2.33 in the MJ group (p < 0.001). All X-ray examinations showed fracture healing. AHD was significantly decreased in the CJ group (p = 0.006). We did not find significant differences in active ROM between the MJ and CJ groups in the injured arm (p < 0.05). The Constant Score was 75.83 (±14.03) in the CJ group and 82.75 (±10.72) in the MJ group (p = 0.31); DASH Score was 10.16 in the CJ group and 6.25 in the MJ group (p = 0.49). IST showed mean strength of 8.38 kg (±1.75) in the MJ group and 4.61 kg (±1.98) in the CJ group (p = 0.002), ISRT test was 8.7 (±1.64) in the MJ group and 4.95 (±2.1) in the CJ group (p = 0.002). Infraspinatus hypotrophy was detected during inspection in six patients (five in the CJ group and one in the MJ group); it was related to infraspinatus strength weakness in IST and ISRT (p < 0.001).

Conclusions

Infraspinatus-sparing surgical approach for scapular fracture avoids infraspinatus hypotrophy and external-rotation strength weakness. We suggest use of the modified Judet approach for scapular fracture and to restrict the classic Judet approach to only when the surgeon believes that the fracture is not easily reducible with a narrower exposure.

Level of evidence

Level IV.

     

Tibia fractures and NSAIDs. Does it make a difference? A multicenter retrospective study

PurposeThe purpose of this study was to compare healing time for diaphyseal tibia fractures (OTA/AO 42 A, B, C) treated with intramedullary nailing (IMN) in one geographic cohort using nonsteroidal anti-inflammatory drugs (NSAIDs) for post-operative pain control to that of another geographic cohort using opioid medications. The groups represent differing cultural approaches to post-operative pain control. We hypothesized there would be no difference in healing time.MethodsTibia fractures presenting at two level I trauma centers located in different countries between January 1, 2010 and December 31, 2017 were retrospectively screened for enrollment. Fractures classified as OTA/AO 42 A, B, or C that were treated with IMN and had radiographic follow up to union were included. At hospital discharge, one cohort (n = 190) was prescribed NSAIDs and the other (n = 182) was prescribed opioids for pain control. Each analgesic method represented the standard of care for that location. Fracture union was defined as cortical bridging in at least 3 out of 4 cortices on AP and lateral radiographs. The primary outcome was healing time on radiographic evaluation.ResultsThere was no statistically significant difference in healing time between the opioid and NSAID groups: 185 vs 180.5 days respectively (p = 0.64). Both groups had similar mean age. Student t-tests were run to compare rates of tobacco use, diabetes mellitus (DM), open fractures, and polytrauma between the two groups. The opioid cohort had statistically significant higher rates of tobacco use, DM, and polytrauma. The NSAID cohort, however, had a larger number of open fractures.ConclusionThe difference in healing time between the NSAID and opioid groups was not statistically significant. The deleterious effect of NSAID use on fracture healing has been debated for decades. Numerous animal studies have supported this theory; however, high quality clinical studies in humans have not provided convincing evidence to substantiate this negative effect. Our study suggests that NSAIDs may be used safely and effectively in the acute phase of fracture healing without significantly increasing the risk of delayed union or nonunion. Prospective randomized studies are necessary to rule out the negative effect of NSAIDS on bone healing.     

Surgical treatment of acquired flatfoot deformity: what is the state of practice among academic foot and ankle surgeons in 2002?

PURPOSE: This study was performed to review the present approach to the surgical treatment of acquired flatfoot deformity among a cross section of academic foot and ankle surgeons in the United States. METHODS: A typical case of stage II posterior tibial tendon dysfunction was developed. The hypothetical patient was a healthy 62-year-old male with a symptomatic acquired flatfoot deformity with posterior tibial tendon dysfunction. Nonoperative management had failed. A series of academic foot ankle surgeons were surveyed to identify their proposed operative treatment. Each surgeon surveyed was affiliated with an orthopaedic residency program and was directly responsible for teaching orthopaedic residents. Each surgeon had foot and ankle patients as the major component of their practice. The overall response rate was 81% (104/128). RESULTS: Ninety-seven percent (101/104) of respondents reported that they would employ some type of bony procedure in their surgical treatment. Eighty-eight percent (89/104) described techniques that would preserve the subtalar and talonavicular joints. These included a medializing calcaneal osteotomy in 73% (76/104), a lateral column lengthening in 41% (43/104), and a medial column stabilization (first tarsometatarsal and/or navicular cuneiform arthrodesis) in 15% (16/104). Twelve percent (12/104) reported that they would perform an arthrodesis of one or more of the hindfoot joints. Ninety-eight percent (102/104) of respondents reported that they would employ some type of soft-tissue procedure. Ninety-four percent (98/104) would augment the posterior tibial tendon, 53% (55/104) would formally repair the spring ligament, and 70% (73/104) would address a presumed equinus contracture. CONCLUSIONS: There is a wide variation in the approach to surgical treatment of stage II acquired adult flatfoot deformity among academic foot and ankle surgeons. Most surgeons employed a combination of bony and soft-tissue procedures that preserved the subtalar and talonavicular joints.     

Does the site of injection distal to the greater trochanter make a difference in lateral sciatic nerve blockade?

The two components of the sciatic nerve become more distant from one another in their course down the lower limb. This may have clinical implications if a small volume of local anesthetic is used with a single injection technique. In this prospective, randomized, double-blind study, we compared two different injection sites, 20 cm and 30 cm distal to the greater trochanter, in terms of onset time and success rate of sciatic nerve blockade after a single injection of 20 mL of 1.5% mepivacaine. Fifty patients undergoing foot surgery were randomly allocated to receive a lateral sciatic nerve blockade using one of 2 levels: 20 cm distal to the greater trochanter (group proximal; n = 25) and 30 cm distal to the greater trochanter (group distal; n = 25). Twenty milliliters of 1.5% mepivacaine was injected after a flexion plantar response was obtained at <0.5 mA. Time required for onset of sensory and motor blockade of the foot was recorded. Success rate was defined as complete sensory and motor blockade in all sciatic nerve distributions associated with a pain-free surgery. Onset of complete sensory and motor blockade was faster in group proximal (12 +/- 7 min and 15 +/- 8 min, respectively) compared with group distal (19 +/- 9 min and 23 +/- 9 min; P < 0.05). Group proximal also had a more frequent success rate compared with group distal (88% versus 56%, respectively; P < 0.05). It is concluded that in lateral sciatic nerve blockade, a more proximal approach to the sciatic nerve predicts a shorter onset time and more frequent success than a more distal injection site when a single injection and a small volume of local anesthetic is used. IMPLICATIONS: In lateral sciatic nerve blockade, a more proximal approach to the sciatic nerve provides shorter onset times and more frequent success than a more distal injection site when a single injection of 20 mL of mepivacaine 1.5% is used.