A Close Look at Crossovers in Knee RCTs

partial_meniscectomyIn a November 16, 2016 JBJS study whose findings have implications for both research and practice, Katz et al. analyzed data from the MeTeOR trial to answer two questions:

  • What prompts patients with meniscal tears and knee osteoarthritis who are randomized to physical therapy (PT) in trials comparing PT to arthroscopic partial meniscectomy (APM) to cross over from nonoperative therapy to APM?
  • Do those who cross over to APM receive symptom relief that’s comparable to those originally randomized to APM?

After careful multivariate analysis of 48 patients who crossed over in the MeTeOR trial (representing 27% of those originally randomized to PT), the authors identified two factors associated with a higher likelihood of crossover: a baseline WOMAC Pain Score of ≥40 and symptom duration of <1 year.  The authors also found that patients who crossed over to APM were just as likely to experience improvement in pain scores as those originally randomized to APM.

From a research standpoint, the authors suggest that future investigators may wish to make “special efforts” to keep patients who present with severe pain and relatively short symptom duration in nonoperative therapy. Clinically, Katz et al. say the findings “underscore the emerging treatment recommendation…to try a PT regimen before opting for APM.”

Guest Post: Will Rep-Less ORs Improve Surgical Consistency?

OrthoBuzz occasionally receives posts from guest bloggers. The following commentary comes from David Kovacevic, MD in response to a November 14, 2016 article in The Washington Post.

Sandra G. Boodman’s recent column in The Washington Post, ”Why is that salesman in the operating room?… sheds light on the potential for conflicts of interest and other possible pitfalls of having device reps in the OR.  Currently, device reps are required to abide by the ethical standards set forth by AdvaMed, a medical device trade association. In addition, the American Academy of Orthopaedic Surgeons has adopted standards of professionalism regarding orthopaedist-industry conflicts of interest.

Both device rep and surgeon should have one common goal—to do what is in the best interest of the patient. Ultimately, though, the surgeon is responsible for patient welfare and safety.  This includes thorough pre-surgical planning; expertise in surgical anatomy, approach, and technique; complete knowledge about surgical instrumentation and implantable devices; and total transparency in the doctor-patient relationship.  The competent surgeon also manages the surgical team, collaborates with the anesthesia team, and recognizes the device rep’s adjunct role.

The presence of device reps in the operating room should be limited to answering implant-specific questions for the surgical team.  Patient-care problems can arise when the surgical team leader (i.e., the attending surgeon) and surgical team rely too heavily on device reps for technical expertise and assistance.  This can lead to questions as to who really is in charge and accountable.

Several solutions exist for sidestepping such ambiguity.  The consent-for-surgery form should state explicitly that a device rep may be present in the procedure room, and the device rep should wear scrubs or a disposable head cover that is a different color from the OR attire worn by surgical and anesthesia teams. The most effective solution, though, lies in building, developing, and sustaining surgical teams focused on improving operating room efficiency and consistency.  That’s a large undertaking, and the culture change needed for it requires buy-in from multiple stakeholders, such as the medical director of perioperative services, departments in the supply chain, and leaders in anesthesia, surgery, and nursing.

One rationale for a rep-less model is to reduce the cost of implants by working directly with and purchasing from the implant manufacturer and bypassing the group purchasing organization, sales reps, and distributors.  As Boodman’s article explains, for Loma Linda University Medical Center this meant obtaining device inventory directly from the implant manufacturer and training one of its surgical technicians as a de facto rep. The result was at least a 54% reduction in total case costs for primary total hip and total knee replacement procedures and empowering surgical technicians with additional knowledge about implants. It is too early to tell whether this model enhances consistency in the operating room, decreases operative time, or reduces length of stay and 30-day hospital readmission rates.

We should expect ongoing scrutiny of the device rep’s role in the operating room. With help from surgeons, hospitals and health systems should consider developing more effective surgical teams, including surgical techs specially trained about implants, to improve patient outcomes and consistency.

David Kovacevic, MD is associate fellowship director of shoulder and elbow surgery and assistant professor in the Department of Orthopaedics & Rehabilitation at Yale University School of Medicine. He can be reached at david.kovacevic@yale.edu or @KovacevicMD.

 

Updated Knee Content from JBJS

knee-spotlight-image.pngThe recently launched JBJS Knee Spotlight offers highly relevant and potentially practice-changing knee content from the most trusted source of orthopaedic information.

Here are the five JBJS articles to which you will have full-text access through the Knee Spotlight during the month of December 2016:

  • Adult Human Mesenchymal Stem Cells Delivered via Intra-Articular Injection to the Knee Following Partial Medial Meniscectomy

  • Computer Navigation for Total Knee Arthroplasty Reduces Revision Rate for Patients Less Than Sixty-five Years of Age

  • Comparison of Closing-Wedge and Opening-Wedge High Tibial Osteotomy for Medial Compartment Osteoarthritis of the Knee

  • Weight-Bearing Compared with Non-Weight-Bearing Following Osteochondral Autograft Transfer for Small Defects in Weight-Bearing Areas in the Femoral Articular Cartilage of the Knee

  • Early Patient Outcomes After Primary Total Knee Arthroplasty with Quadriceps-Sparing Subvastus and Medial Parapatellar Techniques

Knee studies offered on the JBJS Knee Spotlight will be updated monthly, so check the site often.

Visit the JBJS Knee Spotlight website today.

New JBJS Virtual Recertification Course Now Available

11-2016_VCR_II_Template-Final.jpgThe Second Edition of the JBJS Virtual Recertification Course, in association with the Miller Review Course, is now available.  Featuring 15 updated modules, the course now includes the option to purchase bundles of 3 modules to address your specific educational needs.  Presented by top lecturers, the course is approved for 22.5 AMA PRA Category I credits™ and ABOS-approved for 10 self-assessment examination (SAE) credits.

Each module includes pre- and post-test assessments, hour-long video-learning components, and citations to relevant literature.

Click here to purchase the full 15-module course or five different 3-module bundles.

Topics/faculty presenters include:

  • Adult Hip Reconstruction by Dr. James Browne
  • Adult Knee Reconstruction by Dr. Edward McPherson
  • Basic Science by Dr. Winston Gwathmey
  • Foot and Ankle by Dr. Steven Haddad
  • Hand and Wrist by Dr. Sanjeev Kakar
  • MRI by Dr. Timothy Sanders
  • Pediatric Orthopaedics by Dr. Jeremy Rush
  • Orthopaedic Oncology by Dr. Ginger Holt
  • Rehabilitation by Dr. MaCalus Hogan
  • Spine by Dr. Francis Shen
  • Sports: Upper Extremity by Dr. Kevin Plancher
  • Sports: Lower Extremity by Dr. Mark Miller
  • Test Prep/Statistics by Dr. Stephen Thompson
  • Trauma: Pelvic and Upper Extremity by Dr. Thomas Schaller
  • Trauma: Lower Extremity by Dr. Michael LeCroy

JBJS Webinar: Managing Knee-Arthritis Pain Before and After Surgery

December Webinar Image.jpg

Early on, patients with knee osteoarthritis (OA) often get sufficient pain relief with nonsteroidal anti-inflammatory drugs. But as the condition progresses, many opt for knee replacement. Although knee replacement shows remarkable long-term results, immediate postsurgical pain management is a crucial consideration for orthopaedists and patients.

On Tuesday, December 13, 2016 at 12:30 PM EST, The Journal of Bone & Joint Surgery (JBJS) and PAIN, the official journal of the International Association for the Study of Pain, will host a complimentary webinar focused on relieving pain before and after surgery for knee arthritis.

  • Sachiyuki Tsukada, MD, coauthor of a study in JBJS, will compare pain relief and side effects from intraoperative periarticular injections versus postoperative epidural analgesia after unilateral knee replacement.
  •  PAIN author Lars Arendt-Nielsen, Dr.Med.Sci, will delve into findings from a study examining biomarker and clinical outcomes associated with the COX-2 inhibitor etoricoxib in patients with knee OA.

Moderated by JBJS Associate Editor Nitin Jain, MD, the webinar will include an additional perspective from musculoskeletal pain-management expert Michael Taunton, MD. The last 15 minutes will be devoted to a live Q&A session, during which the audience can ask questions of all three panelists.

Seats are limited, so register now!

Orthopaedic Surgeon Could Be Next HHS Secretary

Rep. Tom Price.jpgAccording to Medscape (registration required) and other media reports, President-Elect Donald Trump has tapped Rep. Tom Price, MD (R-GA) to be the next secretary of the US Department of Health and Human Services (HHS).

Dr. Price, an orthopaedic surgeon, became chair of the House Budget Committee in 2014, and he is a member of the GOP Doctors Caucus, which has vigorously opposed the Affordable Care Act (ACA). Dr. Price has introduced ACA-replacement legislation called the Empowering Patients First Act. Among other things, Dr. Price’s legislation would allow Medicare-eligible people to opt out of the program and purchase private health insurance using tax credits. In the bill’s latest form, people between 18 and 35 years of age would also be eligible to receive $1200 in tax credits to buy health coverage on the individual market.

Dr. Price has taken other stands on health care policy that are consistent with a small-government approach, although he did vote for the Medicare Access and CHIP Reauthorization Act (MACRA), which gradually shifts Medicare from a fee-for-service to pay-for-value system.

HHS Secretary nominees face a confirmation vote in the Senate, but by all accounts, Dr. Price’s personality will not get in the way of that. Donald Palmisano, Jr., executive director of the Medical Association of Georgia, told Medscape that Dr. Price is “approachable and accessible to political friends and foes alike.”

Reperfusion Patterns in Legg-Calve-Perthes Disease

Perfusion_MRI.pngIn the November 16, 2016 edition of The Journal of Bone & Joint Surgery, Kim et al. improve our understanding of how blood flow is restored to the necrotic femoral head in Legg-Calve-Perthes disease. Using a series of perfusion MRI scans, the authors evaluated 30 hips with Stage-1 or -2 disease; 15 of the hips were treated conservatively, and 15 underwent one of three operative interventions.

Revascularization rates varied widely (averaging 4.9% ± 2.3% per month), but the revascularization pattern was similar, converging in a horseshoe-shaped pattern toward the anterocentral region of the femoral epiphysis from the posterior, lateral, and medial aspects of the epiphysis. The MRIs yielded no evidence of regression or fluctuation of perfusion of femoral heads, which casts some doubt on the proposed repeated-infarction theory of pathogenesis for this disease.

In a related commentary, Pablo Castaneda emphasizes that the study was not designed to evaluate the effects of different treatments, but he says knowing about an MRI pattern that is predictive of final outcomes in Legg-Calve-Perthes disease “has potential for improving our prognostic abilities.” Still, neither the commentator nor the authors suggest routinely obtaining serial MRIs in this patient population.

What’s New in Shoulder and Elbow Surgery

reverse_TSA.pngEvery 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, Aaron Chamberlain, MD, MSc, a co-author of the October 19, 2016 Specialty Update on Shoulder and Elbow Surgery, selected the five most clinically compelling findings from among the more than 40 studies summarized in the Specialty Update.

Reverse Shoulder Arthroplasty

Optimizing reverse shoulder arthroplasty implant design continues to be a research focus. There is significant variation among different implants with regard to the amount of lateralization of the center of rotation, and how lateralization affects clinical outcomes is of particular interest.  Authors randomized patients to undergo reverse shoulder arthroplasty with a center of rotation at the native glenoid face or with lateralization.1  Postoperative functional results at a mean follow-up of 22 months were similar between groups overall.  However, when the analysis excluded patients with teres minor muscle degeneration, patients with a more lateralized center of rotation had a greater improvement in external rotation.  This may portend a benefit of lateralization in the setting of an intact posterior rotator cuff.

Rotator Cuff Tear Natural History

A Level-I prospective cohort study of patients with asymptomatic rotator cuff tears evaluated patterns of tear progression over time.2 Of specific interest was whether the integrity of the anterior supraspinatus cable influenced tear size and/or risk for tear enlargement.  Cable-disrupted tears were 9 mm larger at baseline, but cable integrity did not influence risk for tear enlargement or time to enlargement.  This understanding may help inform patient discussions about the risks of nonoperative management of rotator cuff tears.

Rotator Cuff Repair

Do patients with symptomatic degenerative rotator cuff tears fare better with surgery or nonoperative management?   Only three prospective randomized trials have been published comparing outcomes after randomizing patients to nonoperative management or surgical repair. This Level-I trial randomized patients (mean age of 61) with degenerative full thickness cuff tears to either a course of non-operative management (corticosteroid injection, physical therapy, and oral analgesics) or surgical rotator cuff repair. 3 Patients who underwent surgery experienced a greater reduction in VAS pain and VAS disability scores compared with the nonoperative cohort at 1 year of follow-up.

In another prospective randomized study, authors randomized patients who were ≥55 years of age with painful degenerative supraspinatus tears into one of three treatments: 1) physical therapy alone, 2) acromioplasty and physical therapy, and 3) rotator cuff repair, acromioplasty, and physical therapy. Patients in this study were older than those in the study mentioned above, with a mean age of 65 (range 55 to 81).  At the 2-year follow-up, no significant differences among the three interventions were seen in the Constant score, VAS pain score, or patient satisfaction. This data supports initial conservative treatment in older patients with degenerative atraumatic cuff tears.  However, the importance of tear progression over time and the age threshold that separates “older” patients from “younger” patients remain to be determined.

Biological Supplementation

Can we improve the biologic healing environment for rotator cuff repair healing? A Level-I prospective randomized controlled study evaluated leukocyte and platelet-rich fibrin in rotator cuff repairs.4 Patients underwent arthroscopic rotator cuff repair with and without leukocyte and platelet-rich fibrin applied to the repair site. No beneficial effect of leukocyte and platelet-rich fibrin was found in overall clinical outcome, healing rate, postoperative defect size, and tendon quality at the 1-year follow-up.  A reliable biological augmentation solution for rotator cuff healing remains elusive.

References

1            Greiner S, Schmidt C, Herrmann S, Pauly S, Perka C. Clinical performance of lateralized versus non-lateralized reverse shoulder arthroplasty: a prospective randomized study. J. Shoulder Elbow Surg. [Internet]. 2015;24(9):1397–404. Available from: http://www.sciencedirect.com/science/article/pii/S1058274615002864doi:10.1016/j.jse.2015.05.041

2            Keener JD, Hsu JE, Steger-May K, Teefey SA, Chamberlain AM, Yamaguchi K. Patterns of tear progression for asymptomatic degenerative rotator cuff tears. J. Shoulder Elbow Surg. [Internet]. 2015 Dec 1;24(12):1845–1851. Available from: http://linkinghub.elsevier.com/retrieve/pii/S1058274615004759

3            Lambers Heerspink FO, van Raay JJAM, Koorevaar RCT, van Eerden PJM, Westerbeek RE, van ’t Riet E, et al. Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial. J. Shoulder Elbow Surg. [Internet]. 2015;24(8):1274–81. Available from: http://www.sciencedirect.com/science/article/pii/S1058274615002852doi:10.1016/j.jse.2015.05.040

4            Zumstein MA, Rumian A, Thélu CÉ, Lesbats V, O’Shea K, Schaer M, et al. SECEC Research Grant 2008 II: Use of platelet- and leucocyte-rich fibrin (L-PRF) does not affect late rotator cuff tendon healing: a prospective randomized controlled study. J. Shoulder Elbow Surg. [Internet]. 2016 Jan 1;25(1):2–11. Available from: http://linkinghub.elsevier.com/retrieve/pii/S1058274615005388

JBJS Reviews Editor’s Choice–Treating ACL Injuries

Cx5bB4PUkAATggw.jpgOne of the observations that I have made during my years in academic medicine is that the more popular a topic appears to be in the literature, the less likely we are to really understand it. After all, if we need to write about it so much, it must mean that there is still much to learn. This certainly seems to be the case with regard to injuries of the anterior cruciate ligament (ACL). ACL injuries are among the most common injuries sustained in the United States. Over 100,000 ACL reconstructions were performed in the United States in 2006, and the annual rate has continued to increase over time. Although some patients have achieved good results after nonoperative treatment, a survey of the American Orthopaedic Society for Sports Medicine showed that the majority of respondents used nonoperative treatment for fewer than 25% of their patients with ACL injuries.

Noyes et al.1 described the so-called “rule of thirds.” According to this rule, one-third of patients with an ACL injury will compensate well with nonoperative treatment (copers), one-third will avoid symptoms of instability by modifying activities (adapters), and one-third will require operative reconstruction (noncopers). Unfortunately, there does not seem to be any way to predict which group an individual patient will fall into. Thus, there is still substantial ambiguity in determining which patients are most likely to benefit from early intervention with ACL reconstruction following injury.

In this month’s issue of JBJS Reviews, Secrist et al. used the literature to perform a comparison of operative and nonoperative treatment of ACL injuries. They noted that only 3 randomized controlled trials have compared operative and nonoperative treatment of ACL injuries and that 2 of those studies involved the use of ACL suturing as opposed to more modern forms of reconstruction. The third study involved only 32 patients. All studies had substantial methodological limitations. The authors concluded that there have been no Level-I studies comparing ACL reconstruction with nonoperative treatment.

In their review article, Secrist et al. attempted to define and evaluate the available data on the natural history of nonoperatively treated ACL injuries and to determine how the functional outcomes and injury risks associated with nonoperative treatment compared with those associated with reconstruction. Moreover, they sought to define prognostic factors and rehabilitation protocols associated with successful operative outcomes. Finally, they compared the outcomes following early versus delayed ACL reconstruction.

However, by the end of the article, one gets the feeling that the authors have “come full circle.” The authors summarize their findings by saying that some patients can cope with a torn ACL and return to preinjury activity levels, including participation in pivoting sports. On the other hand, patients who have an ACL injury along with a concomitant meniscal injury are at increased risk for osteoarthritis, and it is unclear what effect reconstruction of an isolated ACL has on future osteoarthritis risk in ACL-deficient patients who are identified as “copers.”

I suspect that we will continue to see articles on this topic for many years to come. In light of the “rule of thirds” and the additional impact of meniscal injury, the allocation of a particular patient to operative or nonoperative treatment remains unclear.

Thomas A. Einhorn, MD
Editor, JBJS Reviews

Reference

  1. Noyes FR, Matthews DS, Mooar PA, Grood ES. The symptomatic anterior cruciate-deficient knee. Part II: the results of rehabilitation, activity modification, and counseling on functional disability. J Bone Joint Surg Am. 1983 Feb;65(2):163-74 Medline.

JBJS JOPA Image Quiz: 7-Year-Old Girl with an Injured Wrist

JOPA IQ Wrist Fracture.jpgThis month’s Image Quiz from the JBJS Journal of Orthopaedics for Physician Assistants (JOPA) presents the case of a 7-year-old girl who sustained a wrist injury from a fall off of monkey bars. An initial lateral radiograph is shown here. Clinicians attempted a closed reduction and applied a long arm cast. At the 1-week follow-up visit, radiographs showed additional displacement and increased dorsal angulation.

Select from among five possible choices for the greatest predictor of fracture displacement in the setting of distal radial metaphyseal fractures: increased fracture obliquity, a cast index ratio of less than or equal to 0.7, short arm casting, an intact ulna, or increased initial displacement of the radius.