High-Level Clinical Research in Developing Countries? Yes!
Generally speaking, orthopaedic surgeons in low-resourced environments deliver the best care for their patients with skill, creativity, and passion. These surgeons are accustomed to scrambling for implants and other tools and to working around limited access to operating theaters and anesthesia services. Their everyday struggles usually leave little energy or time to even think about clinical research.
However, in the May 20, 2020 issue of The Journal, Haonga and colleagues prove that, with a “little help from their friends,” it is possible to conduct Level I research while treating patients in a resource-limited setting. They enrolled and followed 221 patients with open tibial fractures (mostly males in their 30s injured in a road-traffic collision) and randomized them to treatment with either uniplanar external fixation or intramedullary (IM) nailing. The nails were supplied by SIGN Fracture Care International, a not-for-profit humanitarian organization that provides specially designed IM nails that can be used without image intensification to hospitals in developing countries around the world. (See related OrthoBuzz post.)
The research was done in Dar es Salaam, Tanzania, in collaboration with trauma surgeons and epidemiologists from the University of California San Francisco, which has a long-standing relationship with Tanzania’s Muhimbili National Hospital. At the 1-year follow-up, there were no significant between-group differences in primary-outcome events—death or reoperation due to deep infection, nonunion, or malalignment. IM nailing was associated with a lower risk of coronal or sagittal malalignment, and quality-of-life (QoL) scores favored IM nailing at 6 weeks, but QoL differences dissipated by 1 year.
Just as important as the clinical findings, these investigators proved that it is possible to do high-level research in centers with high patient volume and limited resources. Future patients will benefit because the clinicians now have better information to share regarding expectations for functional recovery and risk of infection. Physicians and other healthcare professionals benefit because data like this help improve their analytical skills and become more discerning appraisers of the published literature. With strong internal physician leadership and a little outside support, Haonga et al. have convinced us that prospective—and even randomized—research is possible in these special places.
Finally, SIGN deserves our support as a true champion of orthopaedic surgeons working in under-resourced environments. In addition to providing education and implants, SIGN surgeons are required to report their cases through the SIGN Surgical Database—which encourages the research mindset and helps SIGN surgeons improve tools and techniques for better patient outcomes.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
A Rash of Broken Femoral Nails—What’s Up?
I’ll be honest: I have never worried much about breakage of the cephalomedullary nails I implant for proximal femur fractures. Instead, I’m focused on the fracture reduction, soft-tissue handling, and proper implant positioning. These nails are very strong. Sure, failures of these implants may occur and have been reported. But I have never had a lengthy discussion with a patient about the potential risk of the implant breaking during normal activity—and I doubt many other surgeons have either.
That is why the article by Lambers et al. in the May 1, 2019 issue of The Journal grabbed my attention. The authors carefully analyzed 16 cases in which a specific cephalomedullary nail (the TFNA, made from a titanium-molybdenum alloy) broke in 13 patients after an average of 5 months. Of note, 3 patients who underwent a revision with the same type of nail had a repeat fracture of the implant. The majority of these patients had been treated for a reverse oblique intertrochanteric fracture —a type that we all commonly see and treat—and all the fractures had been well reduced at the time of nail insertion.
The implant fractures all occurred at the proximal aperture of the nail and were consistent with fatigue fracture of the alloy. But they all showed a unique “stepped propagation” pattern, whereby, according to the authors, “a planar crack arrested, changed planes by 90°, progressed, arrested, and then changed planes again by 90° until final failure.”
These types of implant failures are not common for this nail, but they apparently happen more often than I thought. I am certain that the manufacturer will be responding to this data, and I look forward to future design changes—especially because the authors hypothesize that prior changes to this nail’s design and/or alloy may have contributed to these breakages. Then again, there may have been errors in technique that made these types of failures more common, or maybe a different implant would have been a better choice for some of these patients. To me, matching fracture type and implant choice is very important.
I look forward to learning more about this issue and will keep these types of implant failures in the back of my mind during hip-fracture cases. In the meantime, Lambers et al. advise “vigilant clinical and radiographic surveillance of patients with unstable hip fracture patterns who undergo osteosynthesis with use of a TFNA implant.”
Chad A. Krueger, MD
JBJS Deputy Editor for Social Media
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: Femoral Fractures, Shoulder Dislocations
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 full-text 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:
Closed Intramedullary Nailing of Femoral Fractures
RA Winquist, ST Hansen Jr, DK Clawson: JBJS, 1984 January; 66 (4): 529
This paper, which carefully explains how IM nailing procedures were refined as the authors’ experience grew from 1968 to 1979, ushered in the standard of care that exists today and spelled the end of traction treatment and plate fixation. It remains one of the most-cited articles in the history of musculoskeletal trauma literature.
Nonoperative Treatment of Primary Anterior Shoulder Dislocation in Patients 40 Years of Age and Younger
L Hovelius et al: JBJS, 2008 May; 90 (5): 945
After 25 years of follow-up, half of >200 primary shoulder dislocations in Swedish patients aged 12 to 25 that had been treated nonoperatively had not recurred or had become stable over time. Based on these findings, the authors opine that “routine, immediate surgery for the treatment of all first-time dislocations in patients 25 years of age or younger will result in a rate of unnecessary operations of at least 30%.”
JBJS Editor’s Choice: Fracture-Care Progress in the Developing World
In the March 1, 2017 edition of The Journal, Eliezer et al. report on their experience managing femoral fractures in a major treatment center in Dar es Salaam, Tanzania, one of many low-resource locations around the world.
The authors tracked one-year outcomes for 331 femoral fractures in 329 patients. The vast majority of those fractures were treated with intramedullary nails, with open reduction and without intraoperative imaging. The actual reoperation rate for nails was 3.4%, with infection being the most common reason for reoperation.
Eliezer et al. also found that the factors most strongly associated with reoperation were proximal fractures with varus coronal alignment, small nail diameter (8 mm vs larger diameters), and a Winquist type-3 fracture pattern (comminution that included 50% to 75% of the femoral shaft).
Road-traffic accidents are the major cause of disability and loss of work productivity in the developing world among the young, economically productive segments of society. Through the support of organizations like SIGN Fracture Care International, local surgeons in low-resource countries have been able to treat patients who’ve sustained diaphyseal long bone fractures safely and with good functional outcomes. Carefully conducted follow-up studies such as this one give data-driven reassurance to everyone who supports these efforts that surgery can be safely conducted with good patient outcomes.
Performing intramedullary fixation allows early weight bearing and joint motion to limit muscle atrophy and joint stiffness. As long as we can be assured that these procedures have acceptably low rates of reoperation and patient morbidity, we can more confidently encourage the expansion of these programs in the developing world. Organizations like SIGN deserve our support in this regard.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
Atypical Femoral Fractures: An Update
We posted our first “Case Connections” article about bisphosphonate-related atypical femoral fractures (AFFs) one year ago. Since then, JBJS Case Connector has published three additional case reports on the same topic, suggesting that it’s time for a revisit. These three recent cases demonstrate that AFFs can occur despite prophylactic intramedullary (IM) nailing of an at-risk femur, that AFFs can present as periprosthetic fractures, and that men taking bisphosphonates—not just women—can experience AFFs.
JBJS Editor’s Choice: IM Nails vs Hip Screws—How Many More Trials Do We Need?
In the December 2, 2015 issue of The Journal, Reindl et al. report on the results of a multicenter randomized trial comparing intramedullary (IM) fixation versus sliding hip screws for stabilization of type A2 unstable intertrochanteric fractures. This trial is yet another product of the Canadian Orthopaedic Trauma Society (COTS), which has collaborated on high-quality clinical trials for more than a decade.
There have been more than 20 RCTs comparing intramedullary fixation with sliding hip screws. Many of these trials exclusively investigated stable fracture patterns or included both stable and unstable fractures. These studies generally concluded that nails provide no clear outcome benefits, except perhaps in unstable fractures. Several meta-analyses have also been published that identified no significant difference in clinical or functional outcomes.
Up until now, there has been little dispute with the recommendation that unstable intertrochanteric fractures be fixed with intramedullary implants. While this current trial confirms radiographic advantages to IM fixation (significantly less femoral-neck shortening) after 12 months, Reindl et al. found but no significant functional advantage (in terms of Lower Extremity Measures, Functional Independence Measures, or timed up-and-go tests) with IM fixation in unstable A2 fractures. These findings add more evidence to the claim that IM implants for both stable and unstable patterns are overused in North America.
The question now becomes how many more trials do we need to further make the point? We know that powerful surgeon-behavior influences exist in academic medical centers that continue to use intramedullary implants routinely for intertrochanteric hip fractures (see the 2010 JBJS prognostic study by Forte et al.). Considering the much higher cost of intramedullary nails relative to hip screws, it is high time that these same centers teach appropriate use of IM implants for these fractures so that trainees become facile with both implant types.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
What’s New in Limb Lengthening/Deformity Correction: Level I and II Studies
Every month, JBJS publishes a Specialty Update—a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Here is a summary of selected findings from Level I and II studies cited in the August 19, 2015 Specialty Update on limb lengthening and deformity correction:
Pediatric Disorders and Trauma
–A modified guided-growth technique for insertion of tension-band plates decreased operative time, radiation exposure, and incision size.1
–Two meta-analyses concluded that, although oral or intravenous bisphosphonates in children with osteogenesis imperfecta increased bone mineral density, evidence of reduction in fracture rates was inconclusive.2, 3
–A systematic review of 40 studies on surgical management of posttraumatic cubitus varus in children noted an overall complication rate of 14.5%, with no single technique being substantially safer or more effective.4
Lower-Limb Trauma/Reconstruction in Adults
–A prospective randomized study on the surgical treatment of complex knee dislocations with ligament reconstruction found a significantly lower risk of delayed ligament failure with adjunctive hinged external fixation compared with a hinged knee brace.
–A prospective randomized study comparing biplanar external fixation with reamed interlocking intramedullary nailing for treating open tibial shaft fractures found similar healing rates and functional outcomes one year postoperatively.5
–Patients with extra-articular distal tibial fractures treated with circular external fixators had earlier weight-bearing and superior function compared with those managed with plate fixation.6
–A randomized controlled trial of patients with medial compartment knee osteoarthritis reported similar radiographic outcomes six years postoperatively among those who had opening-wedge high tibial osteotomy compared with those who had undergone closing-wedge high tibial osteotomy. The closing-wedge group had fewer complications but greater prevalence of conversion to total knee arthroplasty.
Foot and Ankle Reconstruction
–A multicenter prospective study comparing ankle arthroplasty with ankle arthrodesis noted similar patient-reported outcomes, although revision rates and major complications were higher following ankle replacement.
Managing Postoperative Complications
–A comparative study noted a lower prevalence of pin-site infections with the use of chlorhexidine (9.2%) compared with povidone-iodine (27.9%) following external fixation.7
–A randomized study revealed a 27% reduction in external fixation time with the use of low-intensity pulsed ultrasound for tibial osteoplasty.8
–A randomized trial in patients undergoing bilateral tibial lengthening showed no improvement in postoperative pain or ankle-joint mobility following botulinum toxin A injection in the calf muscle.9
New Tools and Techniques
–In a matched-pair study, patients undergoing femoral lengthening using a motorized intramedullary nail showed better consolidation indices, better knee mobility, and decreased complication rates compared with conventional external fixation.10
References
- MasquijoJJ, Lanfranchi L, Torres-Gomez A, Allende V. Guided growth with the tension band plate construct: a prospective comparison of 2 methods of implant placement. J Pediatr Orthop. 2015 Apr-May;35(3):e20
- Dwan K, Phillipi CA, Steiner RD, Basel D. Bisphosphonate therapy for osteogenesis imperfecta. Cochrane Database Syst Rev. 2014;7:CD005088. Epub 2014 Jul 23
- Hald JD, Evangelou E, Langdahl BL, Ralston SH. Bisphosphonates for the prevention of fractures in osteogenesis imperfecta: meta-analysis of placebo-controlled trials. J Bone Miner Res.2014 Nov 18
- Solfelt DA, Hill BW, Anderson CP, Cole PA. Supracondylar osteotomy for the treatment of cubitus varus in children: a systematic review. Bone Joint J. 2014May;96-B(5):691-700
- Rodrigues FL, de Abreu LC, Valenti VE, Valente AL, da Costa Pereira Cestari R,Pohl PH, Rodrigues LM. Bone tissue repair in patients with open diaphyseal tibial fracture treated with biplanar external fixation or reamed locked intramedullary nailing. Injury. 2014 Nov;45(Suppl 5):S32-5
- Fadel M, Ahmed MA, Al-Dars AM, Maabed MA, Shawki H. Ilizarov external fixation versus plate osteosynthesis in the management of extra-articular fractures of the distal tibia. Int Orthop. 2015 Mar;39(3):513-9. Epub 2014 Dec 5
- Cam R, Demir Korkmaz F, Oner Şavk S. Effects of two different solutions used in pin site care on the development of infection. Acta Orthop Traumatol Turc.2014;48(1):80-5
- Salem KH, Schmelz A. Low-intensity pulsed ultrasound shortens the treatment time in tibial distraction osteogenesis. Int Orthop. 2014 Jul;38(7):1477-82. Epub 2014 Jan 7
- Lee DH, Ryu KJ, Shin DE, Kim HW. Botulinum toxin A does not decrease calf pain or improve ROM during limb lengthening: a randomized trial. Clin Orthop Relat Res.2014 Dec;472(12):3835-41
- Horn J, Grimsrud Ø, Dagsgard AH, Huhnstock S, Steen H. Femoral lengthening with a motorized intramedullary nail. Acta Orthop. 2015 Apr;86(2):248-56. Epub 2014 Sep 5
JBJS Classics: The “Game Changer” for Managing Femoral Shaft Fractures
Each month during the coming year, OrthoBuzz will bring 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 will 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.
The classic 1984 JBJS review of 520 cases of intramedullary (IM) nailing by Winquist, Hansen, and Clawson changed everything for patients with fractures of the femoral shaft.
In North America during the 1960s and 70s, the debate was all about details of traction management for femoral-shaft fractures: Balanced skeletal traction versus Perkins traction, where to place the traction pin, how many weeks until the spica cast and what type of spica cast, and whether a fracture brace was a viable option. At the same time in Europe, the Swiss orthopaedic community, which was the focal point for the AO, was advocating plate fixation to avoid “fracture disease,” pneumonia, and pulmonary emboli by mobilizing patients.
Meanwhile, Kay Clawson had traveled extensively in Europe and became aware of the outstanding results being achieved with closed, reamed, femoral nailing, as published (originally in German) by Gerhard Kuntscher. Dr. Clawson ordered the equipment—including the reamers, intramedullary nails, and fracture table—and had them shipped to the University of Washington in Seattle.
There they sat on a pallet for more than a year until Dr. Clawson sent Bob Smith, one of the chief residents, to Europe to work with Kuntscher directly. Dr. Smith brought back the knowledge to do reamed IM nailing of the femur, and as experience increased, a Spokane farm boy turned orthopaedic resident named Ted Hansen became especially skilled at the procedure. When Dr. Hansen became an attending, he taught the procedure to another highly skilled resident, Bob Winquist.
Experience grew to the point where they were able to publish this classic manuscript with all its tips, tricks, and outcomes, including which fracture patterns could be treated without keeping patients in traction for weeks to maintain length, and which fractures required open cerclage to create length stability. During this time, there were no commercially available interlocking nails, so we developed ways to drill holes through Kuntscher rods and inserted cortical screws through them with free-hand technique. We also began retrograde nailing these fractures by increasing the bend of the rods to allow them to be inserted off the articular surface in the medial condyle.
This paper, which also carefully explains how procedures were refined as the authors’ experience grew from 1968 to 1979, ushered in the standard of care that exists today and spelled the end of traction treatment and plate fixation. It remains one of the most-cited articles in the history of musculoskeletal trauma literature.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
JBJS Editor’s Choice—Clavicle-Fracture Fixation and Golf-Club Selection
Golf enthusiasts endlessly debate club design and selection when approaching standard situations on the course. For example, for a shot to a large green from 100 yards, one golfer might choose a pitching wedge, while another would opt for a sand wedge or even a chocked-down nine iron. There are no style points in golf for this shot—what matters is getting the ball close to the pin.
There is a strong similarity between this club-selection dilemma and fixation of midshaft clavicle fractures. Two well-done Level I randomized controlled trials in the April 15, 2015 edition of The Journal (van der Meijden et al. and Andrade-Silva et al.) support the notion that, when a patient’s fracture displacement and clinical characteristics warrant fixation, it does not matter whether the surgeon chooses an intramedullary pin or a plate. This decision must be made based on the surgeon’s experience, skill, prior outcomes, and a candid discussion of the options with the patient.
One area of particular concern is the highly comminuted midshaft fracture that is not length-stable. The Andrade-Silva et al. trial showed that, in this setting, the reconstruction plate may well result in clavicular shortening that is statistically greater than shortening with the intramedullary device, but was not found to be clinically important. Still, in those cases a more rigid plate construct may be preferable.
Otherwise, pin or plate achieves equivalent clinical outcomes, just as the sand wedge and pitching wedge can both get the ball close to the pin. It is the experience and skill of the person with the club in hand that matters.
Click here for a commentary by Gordon Groh, MD on the Andrade-Silva et al. article.
Marc Swiontkowski, MD
JBJS Editor-in-Chief
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