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
Clavicle Fracture Research: Enough Already?
Orthopaedic surgeons and their staffs are aware of the paradigm shift that has taken place in the last 10 to 15 years regarding the treatment of clavicle fractures. Interest in the outcome differences between surgical and nonsurgical treatment has grown substantially since the 2007 Canadian Orthopaedic Trauma Society publication in JBJS showed that, relative to nonoperative treatment, plate fixation of displaced midshaft clavicle fractures resulted in improved functional outcomes and fewer malunions in active adult patients. Since that time, The Journal alone has published 14 articles related to management of clavicle fractures. In addition, the orthopaedic literature contains a number of well-conducted meta-analyses on the topic, comparing both nonoperative and surgical treatment as well as different methods of surgical fixation.
So, with all this evidence, why have we published the randomized controlled trial on this topic by King et al. in the April 3, 2019 issue of The Journal? Partly because the authors build upon our knowledge by comparing a relatively new fixation device (a flexible intramedullary locked nail) to a more standard treatment (an anatomically contoured plate). These plate and nail devices are very different from one another in terms of mechanics and surgical technique, and the flexible nail used in this study is much different than the rigid, straight nails or pins that have been used in the past.
A union rate of 100% was observed in both groups, but the authors found that the flexible nail was significantly faster in terms of operative time. (A single surgeon experienced with both devices performed all 72 surgeries.) They also found that the DASH scores between the groups were similar until the 12 month follow-up, at which point the flexible intramedullary nail group had statistically better scores. The authors concede, however, that the 12-month DASH-score difference “might not be clinically relevant.”
There is one other reason why we deemed this article important: The flexible intramedullary device used in this study is substantially more expensive than prior fixation devices that have been shown to effectively treat clavicular fractures. King et al. did not compare device costs, but whenever we study a device that adds to the total cost of care we should attempt to prove that it adds enough patient benefit to warrant the added expense. As the authors conclude, both devices evaluated in this study appear to be effective at treating displaced/shortened clavicular fractures, and there are a number of other factors that both the surgeon and patient should consider (such as surgeon skill and experience and cosmetic results) when deciding which treatment to use.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
JBJS 100: Shoulder Impingement and Distraction Osteogenesis
Under one name or another, The Journal of Bone & Joint Surgery has published quality orthopaedic content spanning three centuries. In 1919, our publication was called the Journal of Orthopaedic Surgery, and the first volume of that journal was Volume 1 of what we know today as JBJS.
Thus, the 24 issues we turn out in 2018 will constitute our 100th volume. To help celebrate this milestone, throughout the year we will be spotlighting 100 of the most influential JBJS articles on OrthoBuzz, making the original content openly accessible for a limited time.
Unlike the scientific rigor of Journal content, the selection of this list was not entirely scientific. About half we picked from “JBJS Classics,” which were chosen previously by current and past JBJS Editors-in-Chief and Deputy Editors. We also selected JBJS articles that have been cited more than 1,000 times in other publications, according to Google Scholar search results. Finally, we considered “activity” on the Web of Science and The Journal’s websites.
We hope you enjoy and benefit from reading these groundbreaking articles from JBJS, as we mark our 100th volume. Here are two more:
Anterior Acromioplasty for Chronic Impingement Syndrome in the Shoulder
C S Neer: JBJS, 1972 January; 54 (1): 41
For many years after its publication, this 1972 JBJS article changed the treatment approach for patients with shoulder disability. But more recently, arthroscopy and magnetic resonance imaging arthrography have identified other painful non-impingement shoulder conditions. Consequently, the liberal use of acromioplasty to treat “impingement” is being replaced by a trend toward making an anatomic diagnosis, such as a partial or complete rotator cuff tear, and performing aggressive rehabilitation prior to corrective surgery.
Use of the Ilizarov Technique for Treatment of Non-union of the Tibia Associated with Infection
G K Dendrinos, S Kontos, E Lyritsis: JBJS, 1995 June; 77 (6): 835
This case series described a technique of bone transport with bridging achieved by distraction osteogenesis. The defects averaged 6 cm, the mean duration of treatment was 10 months, and the mean time to union was 6 months. More recent research has focused on augmenting the osteogenic potential of tissues in the distraction gap with substances such as bone morphogenetic protein, platelet-rich plasma, and mesenchymal stem cells.
More Clinical Data on the “Clavicle Question”
The last time OrthoBuzz reported on a JBJS randomized trial looking at treatment of midshaft clavicle fractures, the authors concluded that “neither treatment option [nonoperative or surgical] is clearly superior for all patients” and that “the clavicular fracture is preeminently suitable for shared treatment decision-making.”
Now, a multicenter randomized trial by Ahrens et al. published in the August 16, 2017 JBJS adds more data for that shared decision-making discussion. In this trial, 300 patients with a displaced midshaft clavicle fracture were randomized to receive either open reduction and internal fixation (ORIF) with a plate or nonoperative management. Patients were recruited from a range of UK hospitals, and a single implant and standardized technique were used in the operative group. The rehabilitation protocol was the same for both groups.
The union rate in both groups at 3 months was low, approximately 70%. But at 9 months after the injury, the nonunion rate was <1% in the surgically treated patients, compared to 11% in the nonsurgically treated patients. The patient-reported scores (DASH and Constant-Murley) were significantly better in the operative group at 6 weeks and 3 months, but were equivalent to those in the nonoperative group at 9 months.
“Overall,” the authors conclude, “we think that surgical treatment for a displaced midshaft clavicle fracture should be offered to patients, and [these findings] can provide clear, robust data to help patients make their choices.”
Atypical Femoral Fractures: Predicting Post-surgical Healing Problems
Orthopaedic journals and OrthoBuzz have devoted ample space to the apparent association between long-term bisphosphonate use and atypical femoral fractures. The latest insight into this relationship comes from Lim et al. in the December 7, 2016 edition of The Journal of Bone & Joint Surgery. The authors analyzed factors associated with delayed union or nonunion after surgical treatment of 109 atypical femoral fractures in patients who had an average 7.4-year history of bisphosphonate use.
Here’s what Lim et al. found among the 30% of patients studied who had delayed union or nonunion, relative to the 70% who had successful healing:
- Patient Factors: Patients who had problematic fracture healing had a higher BMI, longer duration of bisphosphonate exposure, and higher rate of prodromal symptoms.
- Radiographic/Fracture Factors: Supra-isthmic/subtrochanteric fracture location, femoral bowing of ≥10° in the coronal plane, and a lateral/medial cortical thickness ratio of ≥1.4 were predictive of problematic healing.
- Operative Factors: Iatrogenic cortical breakage around the fracture site and a ratio of ≥0.2 between the remaining gap and the cortical thickness on the anterior and lateral sides of the fracture site were associated with problematic fracture healing.
In an accompanying commentary on the study, Edward J. Harvey, MD notes that most trauma surgeons use cephalomedullary nails to treat atypical femoral fractures, but that “it is impossible from this manuscript to determine what effect the fixation technique had on the outcomes.” He therefore recommends a larger multicenter study using standardized therapy and bone biopsies to further improve understanding in this area.
JBJS Editor’s Choice—Nonunions of Foot/Ankle Fusions Matter
In the December 7, 2016 issue of JBJS, Krause et al. analyze data from a 2013 industry-sponsored RCT to investigate correlations between nonunions of hindfoot/ankle fusions indicated by early postoperative computed tomography (CT) and subsequent functional outcomes. Whether nonunion was assessed by independent readings of those CT scans at 24 weeks or by surgeon composite assessments at 52 weeks, patients with failed healing had lower AOFAS, SF-12, and Foot Function Index scores than those who showed osseous union.
This study suggests that a CT should be obtained from patients who are at least 6 months out from a surgical fusion and are not progressing in terms of activity-related pain and function. Depending on the specific CT findings, a repeat attempt at bone grafting, with the possible addition of bone-graft substitute and/or possible modification of internal fixation, may be warranted to forestall later clinical problems.
Krause et al. imply that trusting plain radiographs that show no indication of fusion failure is not acceptable when patient pain and function do not improve in a timely fashion. Conversely, they conclude that their findings do not support “the concept of an asymptomatic nonunion (i.e., imaging indicating nonunion but the patient doing well),” because nonunions identified early by CT eventually resulted in worse clinical outcomes. The authors also noted that obesity, smoking, and not working increased the risk of nonunion, corroborating findings from earlier studies.
While advanced imaging such as CT is not necessary in foot/ankle fusion patients who are improving in terms of function, pain, and swelling , this study stresses the importance of achieving union following these fusion procedures.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
JBJS Classics: The Küntscher Method of IM Fixation
OrthoBuzz regularly brings you a current commentary on a “classic” article from The Journal of Bone & Joint Surgery. These articles have been selected by the Editor-in-Chief and Deputy Editors of The Journal because of their long-standing significance to the orthopaedic community and the many citations they receive in the literature. Our OrthoBuzz commentators highlight the impact that these JBJS articles have had on the practice of orthopaedics. Please feel free to join the conversation about these classics by clicking on the “Leave a Comment” button in the box to the left.
In 1957 Gerhard Küntscher presented his work on intramedullary (IM) nailing to the American Academy of Orthopaedic Surgeons. His classic JBJS paper on the subject, published in January 1958, summarized his views on this comparatively new technique and encouraged other surgeons to use it for the treatment of long bone fractures and nonunions.
Küntscher pointed out that callus was very sensitive to mechanical stresses, and therefore any treatment method should aim at complete immobilization of the fracture fragments throughout the healing process. External splints, such as plaster casts, did not achieve that, and “inner splints” fixed to the outside of the bone damaged the periosteum.
In advocating for intramedullary fixation, Küntscher was careful to distinguish nails from pins. He was very complimentary about J. and L. Rush, who developed intramedullary pinning, but he pointed out that, unlike pins, nails allowed both longitudinal elasticity and cross-sectional compressibility if they were designed with a V-profile or clover-leaf cross section. This cross-sectional elasticity allowed the nail to fit the canal and expand during bone resorption.
Not only did Küntscher appreciate the biomechanics of the intramedullary nail, but he also pointed out the physical and psychological advantages of early mobilization, particularly in the elderly. He also emphasized that massage was unnecessary—and potentially harmful—during the recovery phase, claiming that any measures that make patients more conscious of their injuries are psychologically disadvantageous.
Küntscher used intramedullary nailing to treat fractures, nonunions, and osteotomies of the femur, tibia, humerus, and forearm. He accepted that it was “a most daring” approach that would destroy the nutrient artery, but he pointed out that proper nailing almost always prevented pseudarthoses and that antibiotics had checked the threat of infection. He said further that perioperative x-rays entailed short exposures and that the “electronic fluoroscope” had, even back then, practically eliminated the risk of x-ray injury to assistants.
The paper clearly illustrates Küntscher’s widespread knowledge and innovative skills. However, it was the subsequent development of locked nails that resulted in intramedullary nailing becoming the treatment of choice for femoral and tibial fractures. Time will tell if modern orthopaedic surgeons will catch up with Küntscher and use nailing for humeral and forearm diaphyseal fractures.
Charles M Court-Brown, MD, FRCSCEd
JBJS Deputy Editor
JBJS Editor’s Choice—Quality-of-Life Measures Emphasize Impact of Long Bone Nonunions
“Health-related quality of life” is easier to say than to measure. In the September 2, 2015 edition of The Journal, Schottel et al. document the impact of a diaphyseal nonunion on health-related quality of life using the well-accepted methodology of time trade-off. In this approach, patients are asked what percentage of their remaining life they would be willing to trade for perfect health, free from the disability in question.
Among the 832 long-bone nonunions studied, Schottel et al. found patients were willing to trade an average of 32% of their remaining lifespan for perfect health. Patients with nonunions of the forearm were willing to trade the greatest percentage of their lives (46%) to be rid of their disability.
This study demonstrates negative impacts of long bone nonunions that are greater than the patient-perceived impacts of diabetes, stroke, or AIDS, with all their attendant comorbidities and medical management issues. These findings serve to re-emphasize how important musculoskeletal function is for optimum quality of life—a fact that all practitioners who treat patients with musculoskeletal issues realize.
I’m certain more than a few of these patients developed a nonunion partly due to poor surgical indications and technique. Hence, our emphasis needs to be on curtailing long bone nonunions through injury-prevention strategies and optimum diagnosis and treatment of diaphyseal fractures. Also, as Mundi and Bhandari point out in their commentary to the Schottel et al. study, “It would behoove orthopaedic care providers to identify early patients with risk factors for nonunion, such that close surveillance and timely intervention can be initiated to minimize nonunion risk.”
Our orthopaedic community should be out in front of this issue with honest evaluations of surgical indications and outcomes so that we can all improve our judgment and surgical skill. While injury mechanisms and severity and patient characteristics undoubtedly also play a major role in the development of long bone nonunions, we orthopaedists should minimize as much as possible our part in creating these high-impact health problems.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
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