Negative Findings from Level-I Trial Still a Step Forward
Donor-site morbidity from harvesting autologous bone graft has driven the decades-long search for a substitute that performs at least as well as a patient’s own bone. Much of the clinical research on donor-site morbidity is flawed by detection bias, but other factors such as operating-room time and expense are still driving the search for the ideal substitute for autologous bone. Still, the discovery of an ideal bone-graft substitute continues to be elusive.
In The November 6, 2019 issue of The Journal, Myerson et al. report findings from a Level-I trial that investigated the use of adipose-derived cellular bone matrix (ACBM) as a graft substitute in patients undergoing subtalar arthrodesis. Among 57 patients who received autograft and 52 who received ACBM, the substitute delivered lower fusion rates as determined by both CT and plain radiographic/clinical evaluations at 6 months. In addition, patients treated with autologous bone graft had lower rates of serious adverse events.
I commend the authors and funders (AlloSource) of this well-designed clinical trial for reporting these negative results, because it is often just as important to know what doesn’t work as what does. (This manuscript was submitted even after AlloSource decided to halt further production of its ACBM product in 2017.) Such transparent reporting saves other investigators and graft substitute-focused companies from going down similar avenues of investigation. Perhaps even more importantly, publishing negative results such as this might save patients from undergoing procedures with similar formulations that would probably have minimal chance of helping and could do harm.
By contributing to the scientific “process of elimination,” this study brings us one step closer to the identification of a worthy substitute for autologous bone graft.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Subtalar Joint’s Middle Facet Yields Insight into Flatfoot
Many foot and ankle surgeons would relish a simple measurement made from a readily available imaging modality to help detect whether patients with adult acquired flatfoot deformity (AAFD) are at high risk for progressive collapse—and to help them with surgical planning. According to the findings from a case-control study by de Cesar Netto et al. in the October 16, 2019 issue of The Journal of Bone & Joint Surgery, that wish may soon be realized.
The authors made standing, weight-bearing computed tomography (CT) scans of 30 patients with stage-II AAFD (mean age of 57.4 years) and 30 matched controls (mean age of 51.8 years). From those images, 2 fellowship-trained surgeons, who were blinded regarding the patient cohorts, measured the amount of subluxation (percentage of uncoverage) and the incongruence angle of the middle facet of the subtalar joint in the coronal plane. The authors found substantial to almost perfect intraobserver and interobserver reliability for both measurements.
Based on these middle-facet measurements, the mean value for joint uncoverage in patients with AAFD was 45.3% compared with 4.8% in controls. Similarly, the mean incongruence angle in the AAFD group was 17.3° in the AAFD group and 0.3° in controls. Further analysis led the authors to conclude that “an incongruence angle of >8.4° and an uncoverage percentage of 17.9% were found to be highly diagnostic for symptomatic stage-II AAFD.”
De Cesar Netto et al. say the biomechanics of the subtalar joint made focusing on the middle facet a sensible approach, and they attributed the high reliability of the measurements to the relatively simple anatomy of the middle facet. Still, because clinical outcomes were not assessed in this study, the role of the middle facet as a marker of peritalar subluxation and a tool for deformity correction in AAFD patients needs further investigation in prospective, longitudinal studies.
Step Monitors Yield New Insight into Ankle Surgery Outcomes
Patients considering surgery for end-stage ankle arthritis often ask which treatment—arthroplasty or arthrodesis—will help the most. Findings from various studies attempting to answer that complex question have been equivocal. In the July 3, 2019 issue of The Journal of Bone & Joint Surgery, Shofer et al. inject some objective data gleaned from step counters worn by 234 patients into this predominantly subjective question.
All patients were treated with either arthroplasty (n = 145) or arthrodesis (n = 89). Their step activity was measured with a StepWatch 3 Activity Monitor preoperatively and at 6, 12, 24, and 36 months postoperatively. In both groups combined, step counts during “high activity” (>40 steps per minute) increased by 46% over 36 months. At 6 months, the mean high-activity step improvement was 194 steps in the arthroplasty group, compared with a mean decline of 44 steps for the arthrodesis group. However, by 36 months after surgery, the between-group differences in high-activity steps had disappeared.
The authors also analyzed associations between the objective step results and 3 patient-reported outcomes (the Musculoskeletal Function Assessment and the SF-36 physical function and pain scores). Unlike the patient-reported scores, which improved dramatically in the first 6 months and then plateaued, improvements in step activity increased gradually throughout the 3-year follow-up.
The authors emphasized that during the first 12 postoperative months, the arthrodesis patients had little or no improvement in step activity, but at 3 years there were no significant differences between arthrodesis and arthroplasty patients. These findings suggest that, in this clinical scenario, an individual patient’s expectations with the pace of improvement may be a suitable topic during shared decision making conversations.
This study does not entirely reconcile previously equivocal findings regarding arthroplasty-versus-arthrodesis, but it does emphasize the substantial and sustained activity benefits that patients in both groups receive. Shofer et al. conclude that objective measurements from wearable technology “may complement patient-reported outcomes” in future longitudinal outcome studies of many orthopaedic treatments.
July 2019 Article Exchange with JOSPT
In 2015, JBJS launched an “article exchange” collaboration with the Journal of Orthopaedic & Sports Physical Therapy (JOSPT) to support multidisciplinary integration, continuity of care, and excellent patient outcomes in orthopaedics and sports medicine.
During the month of July 2019, JBJS and OrthoBuzz readers will have open access to the JOSPT article titled “Effectiveness of Foot Orthoses Versus Corticosteroid Injection for Plantar Heel Pain: The SOOTHE Randomized Clinical Trial.”
Among 103 patients with plantar heel pain who received either arch-contouring foot orthoses or a single ultrasound-guided corticosteroid injection, the injection was more effective at week 4, but the foot orthoses were more effective at week 12. But the authors note that “the differences between the interventions did not meet the previously calculated minimal [clinically] important difference value of 12.5 points.”
What’s New in Foot and Ankle Surgery 2019
Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of all OrthoBuzz Specialty Update summaries.
This month, Chad A. Krueger, MD, JBJS Deputy Editor for Social Media, selected the five most clinically compelling findings from among the 60 noteworthy studies summarized in the May 15, 2019 “What’s New in Foot and Ankle Surgery.”
Syndesmotic Injury
–In a Level-II prospective cohort study, 48 patients were reviewed 12 months after transsyndesmotic stabilization with 1 or 2 quadricortically positioned screws.1 Although malreduction of >3 mm or 15° rotation was observed in 30% of the patients, outcome scores were equivalent compared with patients in the anatomically reduced group. Age, obesity, fracture pattern, and screw configuration had no effect on functional outcomes.
Total Ankle Replacement
–A Level-II prospective cohort study compared outcomes of older-generation and newer-generation total ankle replacements (n = 170) with ankle arthrodesis (n = 103). At the 3-year follow-up, both replacement and fusion resulted in improved function and reduced pain, and a pooled comparison of all outcome scores revealed no difference between the 2 procedures. However, subset analyses showed that patients who received newer-generation implants had significantly better outcomes than those who underwent arthrodesis.
Pain Management
–A prospective study analyzing opioid utilization among 988 patients following an outpatient foot and ankle surgical procedure found that only 50% of prescribed opioids were utilized.2 Risk factors for increased opioid consumption included continuous infusion catheter or regional-block anesthesia, age <60 years, high preoperative pain levels, and surgery involving the ankle or hindfoot.
Hallux Rigidus
–Authors of a prospective multicenter series followed 80 patients who underwent a first metatarsophalangeal joint arthroplasty with a 3-component, unconstrained, cementless implant.3 They reported significant improvement in AOFAS Ankle-Hindfoot Scale scores and range of motion at a median follow-up of 11.5 years, with 91.5% implant survival at 15 years. Two patients had periprosthetic cysts on the metatarsal side and 13 patients had phalangeal cysts, but the presence of cysts did not influence clinical results. Multivariate analysis showed a correlation between reduced AOFAS scores and arthrosis of the metatarsosesamoid junction, prompting the authors to suggest that the sesamoid should be enucleated in the presence of substantial arthrosis, fracture, or chondromalacia.
Clubfoot
–Deformity recurrence following Ponseti casting is often treated surgically. However, a comparative cohort study of 35 patients found that repeat casting and bracing for recurrent clubfoot resulted in acceptable 7-year outcomes in 26 (74%) of the patients. The authors suggest that in many children repeat casting should be the first-line intervention in relapsed deformity.
References
- Cherney SM, Cosgrove CT, Spraggs-Hughes AG, McAndrew CM, Ricci WM, Gardner MJ. Functional outcomes of syndesmotic injuries based on objective reduction accuracy at a minimum 1-year follow-up. J Orthop Trauma.2018 Jan;32(1):43-51.
- Saini S, McDonald EL, Shakked R, Nicholson K, Rogero R, Chapter M, Winters BS, Pedowitz DI,Raikin SM, Daniel JN. Prospective evaluation of utilization patterns and prescribing guidelines of opioid consumption following orthopedic foot and ankle surgery. Foot Ankle Int.2018 Nov;39(11):1257-65. Epub 2018 Aug 19.
- Kofoed H, Danborg L, Grindsted J, Merser S. The Rotoglide™ total replacement of the first metatarso-phalangeal joint. A prospective series with 7-15 years clinico-radiological follow-up with survival analysis. Foot Ankle Surg.2017 Sep;23(3):148-52.
Risk Factors for Persistent Opioid Use after Bunion Surgery
OrthoBuzz has previously reported on studies examining the narcotic-prescribing patterns of foot and ankle surgeons. New findings published by Finney et al. in the April 17, 2019 issue of The Journal of Bone & Joint Surgery strongly suggest that the single most powerful and modifiable risk factor for persistent opioid use after bunion surgery was the opioid dose perioperatively prescribed by the surgeon.
The authors analyzed a US private-insurance database to identify >36,500 opioid-naïve patients (mean age, 49 years; 88% female) who underwent one of three surgical bunion treatments. Among those patients, the rate of new persistent opioid use (defined as filling an opioid prescription between 91 and 180 days after the surgery) was 6.2%, or >2,200 individuals. The authors found that patients who underwent a first metatarsal-cuneiform arthrodesis were more likely to have new persistent opioid use, compared with those who received a distal metatarsal osteotomy, which was the most common procedure performed in this cohort. Additional findings included the following:
- Patients who filled an opioid prescription prior to surgery were more likely to continue to use opioids beyond 90 days after surgery.
- Patients who resided in regions outside the Northeastern US demonstrated significantly higher rates of new persistent opioid use.
- The presence of medical comorbidities, preexisting mental health diagnoses, and substance-use disorders were associated with significantly higher new persistent opioid use.
However, physician prescribing patterns had the biggest influence on new persistent opioid use. A total prescribed perioperative opioid dose of >337.5 mg (equivalent to approximately 45 tablets of 5-mg oxycodone) was the major modifiable risk factor for persistent opioid use in this cohort. The authors also pointed out that 45 tablets of 5-mg oxycodone “is a relatively low amount when compared with common orthopaedic prescribing patterns” (see related JBJS study).
As orthopaedic surgeons in all subspecialties rethink their narcotic-analgesic prescribing habits, they should remember that regional anesthesia and non-opiate oral pain-management protocols have had a positive impact on pain management while minimizing narcotic use. The smallest dose of opioids for the shortest period of time seems to be a good rule of thumb.
Microbiomes, OA, and Diabetic Foot Ulcers
This post comes from Fred Nelson, MD, an orthopaedic surgeon in the Department of Orthopedics at Henry Ford Hospital and a clinical associate professor at Wayne State Medical School. Some of Dr. Nelson’s tips go out weekly to more than 3,000 members of the Orthopaedic Research Society (ORS), and all are distributed to more than 30 orthopaedic residency programs. Those not sent to the ORS are periodically reposted in OrthoBuzz with the permission of Dr. Nelson.
We hear the term “microbiome” with increasing frequency nowadays. Merriam-Webster’s online dictionary defines it as “a community of microorganisms (such as bacteria, fungi, and viruses) that inhabit a particular environment and especially the collection of microorganisms living in or on the human body.” Two recent studies suggest how the microbiome can affect musculoskeletal health.
Incorporating the term “the arthritis of obesity,” Rochester, New York researchers1 used obese mice with trauma-induced knee osteoarthritis (OA) to provide evidence that there is a “gut-joint connection” in the OA degenerative process. After supplementing the diets of some of the mice with oligofructose (a prebiotic fiber), the authors found reduced systemic inflammation, reduced obesity-associated macrophage migration to the synovium, and suppressed obesity-induced joint-structure changes.
Another recent study investigated the on-body microbiome as it relates to diabetic foot ulcers (DFUs). Despite clinical signs and nonspecific biomarkers of infection, there is no specific and sensitive measure available to monitor or prognosticate the success of foot salvage therapy (FST) in patients with DFUs. These investigators hypothesized that the initial microbiomes of healed versus nonhealed DFUs are distinct and that the changes in the DFU microbiome during FST are prognostic of clinical outcome.2
Twenty-three DFU patients undergoing FST had wound samples collected at 0, 4, and 8 weeks following wound debridement and antibiotic treatment. Eleven ulcers healed and 12 did not. Healed DFUs had a larger abundance Actinomycetales and Staphylococcaceae (p < 0.05), while nonhealed ulcers had a higher abundance of Bacteroidales and Streptococcaceae (p < 0.05).
In the future, assessment of the initial microbiome and monitoring changes in the prevalence of specific microbiome constituents in patients with diabetic foot ulcers may be a clinical tool for predicting treatment response to foot salvage therapy. It’s also conceivable that microbiome analysis could eventually help patients and surgeons decide between FST and amputation.
References
- Schott EM, Farnsworth CW, Grier A, Lillis JA, Soniwala S, Dadourian GH, Bell RD, Doolittle ML, Villani DA, Awad H, Ketz JP, Kamal F, Ackert-Bicknell C, Ashton JM, Gill SR, Mooney RA, Zuscik MJ. Targeting the gut microbiome to treat the osteoarthritis of obesity. JCI Insight. 2018 Apr 19;3(8). pii: 95997. doi: 10.1172/jci.insight.95997. [Epub ahead of print] PMID: 29669931, PMCID: PMC593113
- MacDonald A, Brodell JD Jr, Daiss JL, Schwarz EM, Oh I. Evidence of differential microbiomes in healing versus non-healing diabetic foot ulcers prior to and following foot salvage therapy. J Orthop Res. 2019 Mar 25. doi: 10.1002/jor.24279. [Epub ahead of print] PMID: 30908702
Preventing VTE in Below-the-Knee Surgery
Venous thromboembolism (VTE) following hip fractures and hip/knee arthroplasty—both deep vein thrombosis (DVT) and pulmonary embolism (PE)—has been relatively well studied. We therefore have a fairly clear understanding what the risks for DVT and PE are with no treatment as well as with modern preventive chemotherapeutic agents. However, such clarity on the need for and effectiveness of VTE prophylaxis is lacking for below-the-knee (BTK) orthopaedic procedures. This is largely due to the fact that such procedures have been deemed “low risk”—despite a dearth of supporting evidence for that assumption. In the March 20, 2019 issue of The Journal, Heijboer et al. used a sophisticated propensity score matching methodology to evaluate the rate of VTE in >10,000 BTK surgery patients at their tertiary care referral center.
The authors evaluated patients who underwent orthopaedic surgery distal to the proximal tibial articular surface, including foot/ankle procedures, open reduction of lower-leg fractures, and BTK amputations. They performed propensity score matching to compare 5,286 patients who received any type of chemotherapeutic prophylaxis with the same number who did not, across several key risk categories. The good news is that VTE prophylaxis effectively lowered the risk of symptomatic DVT or PE from 1.9% to 0.7% (odds ratio of 0.38, p <0.001).
Unfortunately (but not surprisingly), this effectiveness came at the price of increased systemic or local bleeding among patients using chemical VTE prophylaxis, with an incidence of 1.0% in the no-prophylaxis group and 2.2% in the prophylaxis group (odds ratio of 2.18, p <0.001). The authors did not assess the incidence of deep infection or hematoma formation, which often accompany increased local bleeding. The low overall incidence of VTE and bleeding did not allow for subgroup analysis according to location of surgery, and aspirin use was not controlled for in their study. In addition, Heijboer et al. used hospital coding data, and the accuracy of the database was not assessed.
The authors recommend that “anticoagulant prophylaxis be reserved only for patient groups who are deemed to be at high risk for VTE,” but we still don’t know precisely who is at high risk among BTK surgery patients. It is my hope that these findings will prompt large, prospective multicenter trials in the foot and ankle community to better determine which types of patients should be exposed to an increased risk of postoperative bleeding complications in order to achieve a clinically important decreased risk of VTE with chemical prophylaxis.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
2018 EST Awards: And the Winners Are…
JBJS Essential Surgical Techniques (EST) and The Journal of Bone and Joint Surgery (JBJS) give out two annual awards–one for the best Subspecialty Procedure (SP) article, and the other for the best Key Procedures (KP) video published during each calendar year.
We are pleased to announce the winners for 2018:
- Editor’s Choice Technique Award:
The Pararectus Approach to Acetabular Fractures: A New Concept
by Marius J.B. Keel, MD, Klaus-Arno Siebenrock, MD, Moritz Tannast, MD, and Johannes D. Bastian, MD - Editor’s Choice Video Award:
Use of Suture Button in the Treatment of Syndesmosis Injuries
by Mette Renate Andersen, MD and Wender Figved, MD, PhD
Full open access to both articles is available for a limited time.
Submissions for the 2019 EST Awards are currently being accepted.
Letting Go of the Script
OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent New England Journal of Medicine Perspective, the following commentary comes from Adam Bitterman, DO.
The physician-patient relationship is highly regarded and has withstood the test of time. Unfortunately, today it appears to be under significant stress. While it is still possible to maintain a meaningful and professional doctor-patient connection, the balance between arriving at a correct diagnosis, moving down your patient list, and truly caring for each individual patient is difficult to find. The advent of electronic medical records (and their attendant task lists and button clicking) and satisfaction scores have not made maintaining meaningful patient relationships any easier.
In her February 7, 2019 Perspective piece for The New England Journal of Medicine, cardiologist Dr. Lisa Rosenbaum describes her encounters with the medical system as a patient after sustaining a Jones fracture. As she highlights her experience from the initial presentation in the emergency department to the follow-up examination with an orthopedic surgeon, she describes the repeated sensation of being a diagnosis treated by an algorithm rather than an individual with an ailment receiving care.
She also highlights an anecdote about another patient’s family pleading with a staff physician to “get off your script” and focus on treating the unique patient. Invoking the legacy of Sir Robert Jones, the orthopaedist after whom the foot fracture is named, Dr. Rosenbaum observes that “medicine teeters atop an edifice of workarounds,” as physicians try to play by the rules while taking good care of patients.
Standardization and treatment protocols have a useful role in many instances, but we physicians must remember that behind every complaint is a patient, an individual with personal connections to friends and family. It is easy to get caught up in the standardized protocols that reside within electronic medical records, but it takes only a moment to disconnect yourself from the screen and keyboard and provide the creative connection that patients desire. (A study in the upcoming February 20, 2019 JBJS addresses this topic.)
Although you may be encountering your seventh patient of the day with a Jones fracture, for each of those people, their foot is all that matters. It is our job—a decidedly difficult one—to provide the unique and sometimes creative treatment plan to all our patients, while somehow maintaining a top-tier standard of care that is reproducible for all.
Adam Bitterman, DO is a fellowship-trained foot and ankle surgeon practicing at Northwell Health in Huntington, NY. He is also a member of the JBJS Social Media Advisory Board.
Recent Comments