We have entered an era where total ankle arthroplasty (TAA) is accepted as a rational approach for patients with degenerative arthritis of the ankle. TAA results have been shown to be an improvement over arthrodesis in some recent comparative trials.
That was not always the case, however. In the 1980s, the orthopaedic community attacked ankle joint replacement with gusto, and numerous prosthetic designs were introduced with great enthusiasm based on short-term cohort studies. Unfortunately, the concept of TAA was all but buried as disappointing longer-term results with those older prosthetic designs appeared in the scientific literature. It took a full decade for new designs to appear and be subjected to longer-term follow-up studies before surgeons could gain ready access to more reliable instrumentation and prostheses. The producers of these implants behaved responsibly in this regard, facilitated by an FDA approval process that had increased in rigor.
In the December 21, 2016 issue of The Journal, Hofmann et al. publish their medium-term results with one prosthetic design that was FDA-approved in 2006. Implant survival among 81 consecutive TAAs was 97.5% at a mean follow-up of 5.2 years. There were only 4 cases of aseptic loosening and no deep infections in the cohort. Total range of motion increased from 35.5° preoperatively to 39.9° postoperatively.
The fact that a high percentage (44%) of ankles underwent a concomitant procedure at the time of TAA attests to the need for careful preoperative planning for alignment of the ankle joint and the need for thorough assessment of the hindfoot. The fact that a substantial percentage (21%) of ankles underwent another procedure after the TAA attests to the need for thoughtful benefit-risk conversations with patients prior to TAA.
I think the TAA concept and procedure are here to stay, but we still have much work to do in fine-tuning prosthetic designs and instrumentation and enhancing surgeon education for more reliable outcomes.
Marc Swiontkowski, MD
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
OrthoBuzz occasionally receives posts from guest bloggers. In response to a recent JAMA study, the following two commentaries come from Chad Krueger, MD, and Shahriar Rahman, MS.
“Hmmm…. Maybe I’m operating on too many ankle fractures.” That was my first thought as I read the abstract of the recent Willett et al. study in JAMA. They conducted a well-designed, randomized controlled trial that compared operative and nonoperative treatment of unstable ankle fractures, using the Olerud-Molander Ankle Score at 6 months postoperatively as the primary outcome measure.
On the surface, it appeared as though patients who were treated nonoperatively with close contact casting did just as well as those who underwent operative intervention. This seemed to be not only the case with the primary outcome measure, but also with secondary outcomes such as quality of life, pain, and patient satisfaction. “Do less” appeared to be the main message of the abstract. However, I became more skeptical after critically reading the entire article.
First off, the study was designed to determine differences between treatment groups, not to prove that they were equivalent. Finding no difference is not the same as showing equivalence, and the article did the former, not the latter.
There are also a few things about the study that may limit the wide applicability of the findings and provide some solace to surgeons like me who feel that fixing unstable ankle fractures provides superior outcomes. First, only initial radiographs were used to determine who had unstable ankle fractures. Stress radiographs were an exclusion criterion, so for the many ankle fractures that require such imaging to determine instability, the results from Willett et al. may not apply.
Second, the study was designed to compare these treatments in older adults. The mean ages of operative and nonoperative groups were 69.8 and 71.4 years old, respectively, and almost 75% of both groups were female. While bone density was not measured in either group, it is likely that many patients included in this study had osteoporotic disease, which introduces another potential variable when interpreting the findings.
Furthermore, nearly 20 percent of all patients who initially were treated with casting developed some type of complication that required conversion to surgical fixation. This finding, plus the fact that all casts were applied by surgeons in the operating room with patients under general or spinal anesthesia, suggests that treating unstable ankle fractures with surgical fixation in a single visit would perhaps provide the most definitive treatment.
So, I will probably continue to offer patients with unstable ankle fractures surgical fixation. I have never tried the close contact casting that was described in the article, and I suspect, despite the authors’ claim of evidence to the contrary, that there is a significant learning curve associated with that technique. If about one out of every five patients I perform casting on as definitive treatment ends up needing additional procedures, I am not sure I have done the patient justice. While this study provides interesting evidence and may apply to a small subset of my older patients, I think it has limited applicability in other patients who present with unstable ankle fractures.
Chad Krueger, MD is a military orthopaedic surgeon at Womack Army Medical Center in Fort Bragg, North Carolina.
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The Willett et al. study in JAMA indicates that some patients older than 60 years with unstable ankle fractures can be treated by modified casting alone, without the need for operative stabilization and fixation. The study protocol allowed conversion to surgery among patients randomized to casting if reduction was not possible during the initial procedure or was lost within the first 3 weeks.
One hundred surgeons applied close contact casting at 24 major trauma centers and general hospitals in the UK. After 6 months, the mean Olerud-Molander Ankle Score was 66.0 in the surgery group vs 64.5 in the casting group—no significant difference in the primary outcome.
Secondary outcomes showed that the rate of radiographic malunion was 15% in the casting group compared with 3% in the surgery group. Conversion from casting to operative treatment was high: of the 311 patients randomized to casting, 70 (23%) were ultimately treated by internal fixation, including 18 never treated with close contact casting and 52 who lost reduction and required conversion to internal fixation. Rates of infection and wound complications were 10% in the surgical group versus 1% in the casting group. Additional operating room procedures were required in 6% of the surgery group and 1% of the casting group. Casting required less operating room time compared with surgery.
The overall similarity in clinical outcomes in this study challenges the importance of restoring exact ankle-joint congruence in older adults and suggests that function and pain are not as closely related to malunion as many clinicians believe. Neither method yielded an entirely satisfactory outcome in older adults. In older patients with lower demand, shorter life expectancy, lesser bone and tissue quality, and diminished capacity for healing, the rates of delayed or infected wound healing and loss of implant fixation are greater.
Casting may be an imperfect alternative to surgery particularly in developing countries. One must remember, however, that plaster technique is an art. Achieving the successful outcomes with close contact casting as described by Willett et al. is likely to pose a learning curve. Further studies are needed to identify which specific patients are most and least likely to benefit from casting.
Shahriar Rahman, MS is a consultant orthopaedic surgeon at the Ministry of Health & Family Welfare in Bangladesh.
Despite the remarkable success of modern treatments for congenital clubfoot, including the Ponseti method, some kids still end up with a rigid residual deformity after walking age. In the October 19. 2016 edition of JBJS, Dragoni et al. investigated the Ponseti treatment in 44 patients (68 feet; mean age of 4.8 years) who had been previously treated with various surgical and conservative protocols but whose outcomes were fair or poor, according to International Clubfoot Study Group scores.
The authors performed Ponseti manipulation and cast application with the patients under conscious sedation. Depending on the clinical situation, some patients also received percutaneous heel-cord surgery or percutaneous fasciotomy, and all those over 3 years old (88% of the feet) received tibialis anterior tendon transfer (TATT).
At a mean follow-up of just under 5 years, 84% of the feet had achieved excellent or good results. No feet showed a lack of plantar flexion or were not plantigrade. Despite the mobility problems that a series of long leg Ponseti casts posed for kids of walking age, the authors reported that “families enthusiastically agreed to continue the Ponseti treatment as soon as they looked at the improved shape of their child’s foot after removal of the first plaster cast.”
The practice of orthopaedic surgery is moving fairly rapidly to the outpatient environment. Advances in less invasive surgical procedures, regional anesthesia, and postoperative pain management have provided the foundation for this transition. The migration to outpatient surgery centers enables surgeons to use surgical teams more focused on orthopaedic technology and practice parameters. The concern that arises in everyone’s mind, though, is the issue of safety.
In the October 19, 2016 issue of JBJS, Qin et al. analyzed the NSQIP database and found that the outpatient surgical treatment of patients with a closed ankle fracture and minimal comorbidities resulted in lower risk of pneumonia and no difference in surgical morbidity, reoperations, and readmissions when compared with inpatient surgery.
The NSQIP dataset is voluntary and, as with any database, confounding variables are unavoidable. But these authors used propensity score matching and Bonferroni correction to minimize selection bias and manage multiple comparisons.
The study excluded emergency cases, cases with preoperative sepsis, and cases of open ankle fracture, and I can still foresee that patients with more severe fracture patterns, soft tissue compromise, and unstable medical comorbidities would be better off treated as inpatients. Nevertheless, it is reassuring that this study found no differences in complication or readmission rates. These findings reinforce the movement of orthopaedic surgical practice to the outpatient setting, and in my experience that movement is wholly welcomed by patients and their families.
Marc Swiontkowski, MD
Relapse of clubfoot deformity has been attributed to non-adherence to post-corrective bracing recommendations. The October 5, 2016 issue of The Journal of Bone & Joint Surgery contains a study by Sangiorgio, et al. in which wireless sensors measured the actual brace use in 44 patients aged 6 months to 4 years who were supposed to use a post-corrective foot abduction orthosis for an average of 12.6 hours per day. The authors compared the mean number of hours of daily brace use as measured by the sensors with the physician-recommended hours and with parent-reported hours of brace use.
Here’s what Sangiorgio et al. found:
–Median brace use recorded by the sensors was 62% of that recommended by the physician and 77% of that reported by parents.
–18% of the patients experienced relapse. The mean number of daily hours of brace use for those patients (5 hours a day) was significantly lower than the 8 hours per day for those who didn’t experience relapse.
While this study suggests that 8 hours or more of daily brace use may be helpful to prevent relapse, studies with larger cohorts will be needed to determine more definitive bracing minimums. Still, the authors say that “routine brace monitoring has the potential to accurately identify patients who are receiving an inadequate number of hours of brace use and facilitate more effective counseling of these families.”
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. Click here for a collection of all OrthoBuzz Specialty Update summaries.
This month, David Teague, MD, co-author of the July 7, 2016 Specialty Update on orthopaedic trauma, selected the eight most clinically compelling findings from among the 35 studies summarized in the Specialty Update.
–The randomized PROFHER trial found that surgical treatment of acute displaced proximal humeral fractures (with either ORIF or hemiarthroplasty) yielded no difference in patient outcomes compared with nonsurgical sling treatment at time points up to 2 years. Surgery was also significantly more expensive.1
–A randomized trial of 461 patients with an acute dorsally displaced distal radial fracture found no difference at one year in primary or secondary outcomes between a group that received ORIF and a group that received Kirschner-wire fixation. K-wire fixation was also more cost-effective.2
–A retrospective study of 137 type-III open tibial fractures concluded that both antibiotic prophylaxis and definitive wound coverage should occur as soon as possible for severe open tibial fractures. Prehospital antibiotic administration should be considered when transport is expected to take longer than one hour. 3
–A randomized trial of 214 patients who received either supervised physical therapy or engaged in self-directed home exercise after six weeks of immobilization treatment for an ankle fracture found no difference in activity and quality-of-life outcomes at 1, 3, and 6 months.4
–A registry study examining the incidence of deep venous thrombosis (DVT)/pulmonary embolism (PE) after surgery for a fracture distal to the knee identified the following risk factors for a thromboembolic event: previous DVT or PE, oral contraceptive use, and obesity.
–A randomized controlled trial of 2,447 patients compared irrigation with normal saline solution at various pressures to castile soap irrigation. Saline was superior in terms of reoperation rates after 12 months but irrigation pressure did not influence the reoperation rate.5
–A retrospective cohort study involving 104 patients who required a fasciotomy found that hospital stays were shorter among patients who underwent delayed primary closure (DPC) or a split-thickness skin graft on the first post-fasciotomy surgery. The authors noted limited utility of repeat surgeries to achieve DPT if fasciotomy wounds were not closed primarily on the first return trip.6
–A prospective observational study of 376 trauma patients requiring orthopaedic surgery found that those with a BMI of >30 kg/m2 had an overall complication rate of 38% and had longer hospital stays, longer delays to definitive fixation, and higher infection rates than nonobese patients.7
- Rangan A, Handoll H, Brealey S, Jefferson L, Keding A, Martin BC, Goodchild L, Chuang LH, Hewitt C,Torgerson D; PROFHER Trial Collaborators. Surgical vs nonsurgical treatment of adults with displaced fractures of the proximal humerus: the PROFHER randomized clinical trial. JAMA. 2015 Mar 10;313(10):1037-47.
- Costa ML, Achten J, Plant C, Parsons NR, Rangan A, Tubeuf S, Yu G, Lamb SEUK. UK DRAFFT: a randomised controlled trial of percutaneous fixation with Kirschner wires versus volar locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius. Health Technol Assess.2015 Feb;19(17):1-124: v-vi
- Lack WD, Karunakar MA, Angerame MR, Seymour RB, Sims S, Kellam JF, Bosse MJ. Type III open tibia fractures: immediate antibiotic prophylaxis minimizes infection. J Orthop Trauma. 2015 Jan;29(1):1-6.
- Moseley AM, Beckenkamp PR, Haas M, Herbert RD, Lin CW; EXACT Team. Rehabilitation after immobilization for ankle fracture: the EXACT randomized clinical trial. JAMA. 2015 Oct 6;314(13):1376-85.
- Bhandari M, Jeray KJ, Petrisor BA, Devereaux PJ, Heels-Ansdell D, Schemitsch EH, Anglen J, Della RoccaGJ, Jones C, Kreder H, Liew S, McKay P, Papp S, Sancheti P, Sprague S, Stone TB, Sun X, Tanner SL,Tornetta P 3rd., Tufescu T, Walter S, Guyatt GH; FLOW Investigators. A trial of wound irrigation in the initial management of open fracture wounds. N Engl J Med. 2015 Dec 31;373(27):2629-41. Epub 2015 Oct 8.
- Weaver MJ, Owen TM, Morgan JH, Harris MB. Delayed primary closure of fasciotomy incisions in the lower leg: do we need to change our strategy? J Orthop Trauma. 2015 Jul;29(7):308-11.
- Childs BR, Nahm NJ, Dolenc AJ, Vallier HA. Obesity is associated with more complications and longer hospital stays after orthopaedic trauma. J Orthop Trauma. 2015 Nov;29(11):504-9.
Since its introduction in the late 20th century, the 2-stage induced membrane technique has been lauded for its bone-reconstruction advantages over alternatives such as distraction osteogenesis and vascularized bone. The cases presented in this month’s “Case Connections” demonstrate that the technique can work with a variety of bone-defect shapes, sizes, and locations.
The springboard case, from the August 10, 2016 edition of JBJS Case Connector, describes 3 cases of chronic post-infection osteomyelitis in children in whom large diaphyseal defects were successfully treated with the induced membrane technique. Three additional JBJS Case Connector case reports summarized in the article focus on:
- a 50-year-old diabetic man with a necrotic foot ulcer in whom an extensive midfoot defect was successfully treated with this technique
- successful induced-membrane treatment of a 7-year-old girl with congenital pseudarthrosis of the clavicle
- 2 cases of trauma-caused segmental bone loss that were treated successfully with the induced membrane technique
It is imperative to resolve all active infection before or during stage 1 of this procedure, and careful spacer removal prior to stage 2 is of paramount importance to prevent damage to the induced membrane.
A therapeutic Level II study by DiGiovanni et al. in the August 3, 2016 edition of The Journal of Bone & Joint Surgery examined the relationship between successful foot/ankle fusions and the amount of graft material used. The authors found that among 573 procedures in which graft material (either autograft or AUGMENT bone graft) occupied ≥50% of the cross-sectional fusion space at nine weeks, 81% were successfully fused at 24 weeks. However, among 101 procedures with <50% of the graft space filled, only 21% were successfully fused at 24 weeks.
The authors determined both graft-fill percentages at nine weeks and fusion success at 24 weeks using CT scans. The percentage of graft fill was estimated by mental summation of graft fill present in each individual CT slice of the joint, and joint fusion was determined by measuring the percentage of osseous bridging in the same semiquantitative manner.
The significant fusion rate differences between joints with and without ≥50% graft fill were consistent regardless of whether autograft or allograft was used and regardless of which joint was fused. The authors conclude that these findings “demonstrated that when a surgeon can eliminate bone-to-bone gaps in any joint intended for fusion,…such a joint has a significantly better chance of ultimately achieving fusion,” although they caution against “overpacking a joint with excessive graft material.” DiGiovanni et al. cite the need for further research “to determine the ideal amount of graft material required for a clinically relevant and impactful effect on fusion” and to help develop “graft materials that are easier to introduce and can be more precisely inserted into the intended fusion space.”