FDA Approves Pradaxa for Thromboprevention After Hip Replacement

The FDA this week approved dabigatran (Pradaxa) for prevention of DVT and pulmonary embolism following hip arthroplasty surgery. The approval follows FDA analysis of two randomized phase 3 trials (RE-NOVATE and RE-NOVATE II) in which patients who took dabigatran experienced lower rates of venous thromboembolism and all-cause death than those who took enoxaparin. Conversely, those taking the higher dose of dabigatran (220 mg) had higher rates of major bleeding than those taking enoxaparin.

The FDA initially approved dabigatran to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation; the recent hip-replacement indication is the fourth in five years for this novel anticoagulant.

Perhaps most significantly for orthopaedists who now might prescribe dabigatran for hip-replacement patients, last month the FDA approved the first drug (idarucizumab, or Praxbind) to reverse the effects of dabigatran, possibly making the higher risk of bleeding with dabigatran less of a clinical concern.

Patient Pain Perception: Two New Studies

The connection between patient pain and clinical orthopaedic outcomes has received much attention lately. Here are relevant findings from two recent studies:

–An in-press study of 48 patients (average age of 72 years) who underwent TKA found that those with low pain thresholds prior to surgery (as measured with VAS scores while a blood-pressure cuff was inflated over the proximal forearm) were more likely to have lower Knee Society pain and function scores two years after surgery than those with moderate or high pain thresholds. The authors use this test in preoperative workups, and they advise patients who grade the cuff stimulus as severe that “their clinical outcomes are expected to be inferior to [those of] other patients,” encouraging such patients to take that into account before consenting to surgery.

–Among more than 1,100 patients (average age of 67 years) who participated in the Multicenter Osteoarthritis Study (MOST), inflammation, as evidenced by synovitis and effusion, was associated with reduced pain thresholds. However, resolution of established inflammation did not deliver a significant change in pain thresholds over two years, leading the authors to conclude that “early targeting of inflammation is a reasonable strategy to test for prevention of sensitization and…reduction of pain severity.”

Including Osseous Fragment in Bankart Repair Yields Good Results

When treating shoulders with a Bankart lesion that includes an osseous fragment, many orthopaedic surgeons excise the fragment while repairing the capsulolabral complex, and then deploy one of various bone-augmentation procedures to address glenoid bone loss. But in the November 18, 2015 issue of JBJS, Kitayama et al. report on positive medium- to long-term results with a procedure that incorporates the osseous fragment into the Bankart repair and thus avoids invasive bone-grafting procedures.

Thirty-eight patients with a chronic osseous Bankart lesion and >15% bone loss of the inferior glenoid who underwent the procedure described by Kitayama et al. were available for follow-up after a mean of 6.2 years. One patient had a redislocation resulting from a traffic accident five months after surgery. But among the remaining patients, the mean Rowe score improved from 30.7 points preoperatively to 95.4 points postoperatively, and the mean WOSI index improved from 26.5% preoperatively to 81.5% postoperatively. Mean glenoid bone loss, measured two different ways using 3-D CT images, improved from 20.4% preoperatively to ‒1.1% postoperatively.

While the authors concede that “the exact time required for osseous union is not known,” they speculate that “if the repair survives without failure at least one year after surgery, a histological osseous union can be expected in the long postoperative period regardless of the amount of glenoid bone loss.” They attribute the normalization of the glenoid anatomy and low recurrence rate found in this study to “excellent fragment reduction and retensioning of the entire inferior glenohumeral ligament.”

CMS Delays Start of Joint-Replacement Bundled Payments til April 1, 2016

The final rule from the Centers for Medicare & Medicaid Services (CMS) regulating “episode-of-care” Medicare payments to hospitals for hip and knee replacements includes a postponed start date of April 1, 2016. The originally proposed implementation date was January 1, 2016.

Approximately 800 hospitals nationwide are subject to the new payment model, which makes hospitals eligible for bonuses or penalties, depending on their quality and cost performance from the day of patient admission to 90 days post-discharge. Based on comments about the initial rule by 400 key stakeholders, CMS also agreed to eliminate penalty payments during the first year of implementation.

Because the CMS model—dubbed Comprehensive Care for Joint Replacement, or CJR—permits gainsharing, individual orthopaedic surgeons could benefit financially if hospitals they are affiliated with receive bonuses. The AAOS commended CMS for revising the methodology for calculating the composite quality score and said that the delayed implementation “adds some flexibility,” but the group is still calling for CMS to “postpose the mandatory implementation feature of the program until at least 85 percent of providers have attained meaningful use [of EHRs] or another metric of infrastructure readiness.”

JBJS Editor’s Choice: Local Antibiotic Delivery for Open Fractures—Ready for an RCT?

In the November 18, 2015 edition of JBJS, Lawing et alswiontkowski marc color. present a well-documented cohort study comparing the outcomes of open-fracture management with local administration of aminoglycoside antibiotics plus systemic antibiotics, versus systemic antibiotics alone. The impact of this intervention on the ultimate rate of deep infection is eye-catching. The deep-infection rate in the local-antibiotic group was 6%, compared to 14.2% in the control group (p = 0.011). Moreover, locally administered aminoglycosides did not have a negative impact on nonunion rates, as one might expect due to the osteocyte toxicity reportedly associated with some aminoglycosides.

There are, however, issues of administrator bias with this study, because the use of local antibiotics was based on attending-surgeon preference. In addition, surgeons make other individual judgments about open-fracture management, such as debridement technique, that were not controlled for in this study. We also went through a period of using local antibiotic drips and catheter pumps in the 1990s that did not seem to yield reproducible results.

Lawing et al. conclude with the hope that their study “will provide support for future prospective, blinded, and randomized trials” focused on this intervention. I believe the data here are compelling enough for one of our trauma clinical-trials networks to plan and conduct an adequately powered trial complete with prospective criteria and blinded outcome adjudication. One reason we publish cohort studies in The Journal is to stimulate just that sort of response in the orthopaedic-research community. It is my hope that within a few years, JBJS editors will be reviewing an RCT manuscript that completes the investigative cycle on this important clinical question.

Marc Swiontkowski, MD

JBJS Editor-in-Chief

What’s New in Shoulder and Elbow Surgery: 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 October 21, 2015 Specialty Update on shoulder and elbow surgery:


–A prospective evaluation of 224 subjects with asymptomatic rotator cuff tears followed annually for an average of five years found that the risk of tear enlargement and muscle degeneration was greater in full-thickness tears, and that pain and supraspinatus muscle degeneration were associated with tear enlargement.

–The authors of a randomized trial comparing physical therapy and primary surgical repair for initial management of degenerative rotator cuff tears concluded that the effects of surgery were not profound enough to justify surgical management for patients who present initially with painful degenerative cuff tears.

–A randomized trial comparing clinical outcomes in 58 patients with a rotator cuff tear and symptomatic acromioclavicular joint arthritis found no differences in function or pain scores between those who underwent cuff repair + distal clavicle resection and those who underwent cuff repair alone.1

–After two years of follow-up, no differences in functional outcomes or rate or quality of postoperative tendon healing were found in a randomized trial comparing patients who received platelet-rich plasma following surgical cuff repair and those who did not.2

–In a three-way randomized trial comparing physical therapy, acromioplasty + physical therapy, and cuff repair + acromioplasty + physical therapy for treating symptomatic, nontraumatic supraspinatus tendon tears in patients older than 55, there were no between-group differences in the mean Constant score one year after treatment.3

–A randomized trial comparing treatments for calcific tendinitis found that ultrasound-guided needling plus a subacromial corticosteroid injection resulted in better functional scores and larger decreases in calcium-deposit size than extracorporeal shock wave therapy.4

–A randomized trial of 196 patients with recurrent traumatic anterior shoulder instability found no significant differences in WOSI and ASES scores or range of motion between groups that underwent open or arthroscopic stabilization procedures.

–A randomized study comparing the effectiveness of immobilization in abduction (15°) and external rotation (10°) versus adduction and internal rotation after primary anterior shoulder dislocation found that after two years, only 3.9% of patients in the abduction/external-rotation group had repeat instability, compared to 33.3% in the adduction/internal-rotation group.5 A separate randomized trial found no significant difference in instability recurrence after one year between a group immobilized in internal rotation (sling) and a group immobilized in adduction and external rotation (brace).6

–A randomized trial of 250 patients (mean age of 65 years) with displaced surgical neck fractures of the proximal humerus compared surgical treatment (internal fixation or hemiarthroplasty) with conservative treatment. Finding no statistically or clinically significant difference in outcomes, the authors concluded that these results do not support the recent trend toward surgical management for proximal humeral fractures.7

–A randomized trial comparing reverse shoulder arthroplasty with hemiarthroplasty for acute proximal humeral fractures found that after two years of follow-up, reverse arthroplasty yielded better functional scores, better active elevation, and fewer complications than hemiarthroplasty.8

–A randomized trial comparing the use of concentric and eccentric glenospheres in reverse shoulder arthroplasty revealed no differences in scapular notching rates or clinical outcomes at a minimum follow-up of two years.

–A systematic review comparing radiographic and clinical survivorship of all-polyethylene versus metal-backed glenoid components used in total shoulder arthroplasty found that all-poly glenoids had a higher rate of radiolucencies and radiographic loosening but a much lower rate of revision after a mean follow-up of 5.8 years.

–A retrospective review found that arthroscopic biopsy was much more accurate than fluoroscopically guided fluid aspiration in diagnosing periprosthetic shoulder infections caused by Propionibacterium acnes.

–In a randomized trial of 76 workers’-comp patients with a displaced midshaft clavicular fracture, those receiving surgical management had faster time to union and return to work and better Constant scores than those managed conservatively.9

–Two studies compared plate fixation with intramedullary fixation for stabilizing clavicular fractures. One that randomized 59 patients found no differences in functional outcomes or time to healing. The other, which randomized 120 patients, found no between-group differences in DASH or Constant-Murley scores, but shoulder function improved more quickly in the plate-fixation group.

–A study that compared standard arthroscopic capsular release with capsular release extending to the posterior capsule for treating frozen shoulder found no difference in postoperative clinical or range-of-motion outcomes between the two groups.10


–A randomized trial comparing regional analgesia to local anesthetic injections in patients undergoing elbow arthroscopy found no differences in pain, oral analgesic use, or patient satisfaction within 48 hours after surgery.11

–A randomized trial comparing eccentric and concentric resistance exercises for the treatment of chronic lateral epicondylitis found that the eccentric-exercise group had faster pain regression, lower pain scores at 12 months, and greater strength increases.12


  1. Park YB, Koh KH, Shon MS, Park YE, Yoo JC. Arthroscopic distal clavicle resection in symptomatic acromioclavicular joint arthritis combined with rotator cuff tear: a prospective randomized trial. Am J Sports Med. 2015 Apr;43(4):985-90.Epub 2015 Jan 12.
  2. Malavolta EA, Gracitelli ME, Ferreira Neto AA, Assunção JH, Bordalo-RodriguesM, de Camargo OP. Platelet-rich plasma in rotator cuff repair: a prospective randomized study. Am J Sports Med. 2014 Oct;42(10):2446-54. Epub 2014 Aug 1.
  3. Kukkonen J, Joukainen A, Lehtinen J, Mattila KT, Tuominen EK, Kauko T, Aärimaa V.Treatment of non-traumatic rotator cuff tears: a randomised controlled trial with one-year clinical results. Bone Joint J. 2014 Jan;96-B(1):75-81.
  4. Kim YS, Lee HJ, Kim YV, Kong CG. Which method is more effective in treatment of calcific tendinitis in the shoulder? Prospective randomized comparison between ultrasound-guided needling and extracorporeal shock wave therapy. J Shoulder Elbow Surg. 2014 Nov;23(11):1640-6. Epub 2014 Sep 12.
  5. Heidari K, Asadollahi S, Vafaee R, Barfehei A, Kamalifar H, Chaboksavar ZA,Sabbaghi M. Immobilization in external rotation combined with abduction reduces the risk of recurrence after primary anterior shoulder dislocation. J Shoulder Elbow Surg. 2014 Jun;23(6):759-66. Epub 2014 Apr 13.
  6. Whelan DB, Litchfield R, Wambolt E, Dainty KN; Joint Orthopaedic Initiative for National Trials of the Shoulder (JOINTS).External rotation immobilization for primary shoulder dislocation: a randomized controlled trial. Clin Orthop Relat Res. 2014 Aug;472(8):2380-6.
  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.
  8. Sebastiá-Forcada E, Cebrián-Gómez R, Lizaur-Utrilla A, Gil-Guillén V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg. 2014Oct;23(10):1419-26. Epub 2014 Jul 30
  9. Melean PA, Zuniga A, Marsalli M, Fritis NA, Cook ER, Zilleruelo M, Alvarez C.Surgical treatment of displaced middle-third clavicular fractures: a prospective, randomized trial in a working compensation population. J Shoulder Elbow Surg.2015 Apr;24(4):587-92. Epub 2015 Jan 22.
  10. Kim YS, Lee HJ, Park IJ. Clinical outcomes do not support arthroscopic posterior capsular release in addition to anterior release for shoulder stiffness: a randomized controlled study. Am J Sports Med. 2014 May;42(5):1143-9. Epub 2014 Feb 28.
  11. Wada T, Yamauchi M, Oki G, Sonoda T, Yamakage M, Yamashita T. Efficacy of axillary nerve block in elbow arthroscopic surgery: a randomized trial. J Shoulder Elbow Surg. 2014 Mar;23(3):291-6. Epub 2014 Jan 15.
  12. Peterson M, Butler S, Eriksson M, Svärdsudd K.A randomized controlled trial of eccentric vs. concentric graded exercise in chronic tennis elbow (lateral elbow tendinopathy). Clin Rehabil. 2014 Sep;28(9):862-72. Epub 2014 Mar 14.

Powdered Vancomycin Cuts Surgical Infection Risk in Diabetic Patients

A recent case-control study in Foot & Ankle International found that high-risk diabetic patients (mean age of 60) undergoing reconstructive foot and/or ankle surgery were 80% less likely to develop a deep surgical-site infection when surgeons applied vancomycin powder to the surgical wound than when they didn’t. The overall likelihood of any surgical-site infection (deep or superficial) was decreased by 73% in patients who received powdered vancomycin. The cost of vancomycin and the risk of complications associated with it are both low, the study noted.

The authors concluded that “based on this study, orthopaedic foot and ankle surgeons may consider applying 500 mg to 1,000 mg of vancomycin powder prior to skin closure in diabetic patients who are not allergic to vancomycin.”

A Reminder about What Orthopaedic Surgeons Should Not Do

Originally posted on OrthoBuzz:

The Choosing Wisely campaign seeks to bring more awareness to tests and procedures that should be discussed between physicians and patients. The campaign was spearheaded by the ABIM Foundation, and the American Academy of Orthopaedic Surgeons (AAOS) partnered with the campaign to develop a list of the five things physicians and patients should question.

  1. Avoid performing routine post-operative deep vein thrombosis ultrasonography screening in patients who undergo elective hip or knee arthroplasty.
  2. Don’t use needle lavage to treat patients with symptomatic osteoarthritis of the knee for long-term relief.
  3. Don’t use glucosamine and chondroitin to treat patients with symptomatic osteoarthritis of the knee.
  4. Don’t use lateral wedge insoles to treat patients with symptomatic medial compartment osteoarthritis of the knee.
  5. Don’t use post-operative splinting of the wrist after carpal tunnel release for long-term relief.

The list was developed after review of approved clinical practice guidelines and included input from specialty society leaders.

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Nov. 23 JBJS Webinar—Supracondylar Humeral Fractures

On Monday, Nov. 23, 2015 at 8:00 PM EDT, JBJS will host a one-hour webinar focused on managing pediatric supracondylar humeral fractures.

Because supracondylar humeral fractures present with various degrees of displacement and concomitant injuries may be difficult to assess precisely, there is no single, accepted protocol for managing this condition.This complimentary webinar, moderated by JBJS Deputy Editor for Pediatrics Paul Sponseller, MD, will examine the efficacy of different approaches to supracondylar humeral fractures—and their neurovascular consequences.

Brain SnipImageScannell, MD and Christine Ho, MD, will explore pulseless supracondylar humeral fractures by presenting findings from separate but related studies published in JBJS in 2013. In addition, John Flynn, MD, will present findings from his 2014 JBJS study, which investigated isolated anterior interosseous nerve (AIN) injuries accompanying supracondylar humeral fractures.Commentary from pediatric orthopaedist Donald Bae, MD will complement the author presentations, and the webinar will conclude with a live audience Q&A session.

Click here to register.

JBJS Editor’s Choice: Age Is Only One Factor in Rotator Cuff Decision Making

swiontkowski marc colorIn the November 4, 2015 Level I JBJS study by Kukkonen et al., patients over the age of 55 were randomized to one of three treatment arms for management of a rotator cuff tear—physical therapy alone and acromioplasty with and without rotator cuff repair. We learn that over a two-year follow up, treatment with physiotherapy produced results as clinically favorable as surgery in this “older” age group, although tear size was significantly smaller in the repair group than in the other two.

As Dr. Ken Yamaguchi points out in his commentary on the study, the average patient age for surgical repair of a rotator cuff tear is currently the mid-50s, and we know that the likelihood of repair failure with lack of healing increases in patients beyond their mid-60s. In fact, historic post-mortem studies have identified rotator cuff tears in 70% to 80% of all subjects, making this is a common wear-and-tear phenomenon among humans, akin to degenerative disc disease and declining hearing and vision.

So is the take-home message from Kukkonen et al. that any patient over the age of 55 should be treated with physiotherapy, with no discussion of surgical repair?  I think not. The message is that we should be more supportive of a decision to start down the physiotherapy path with patients in their mid-50s than ones in their mid-40s. Although this study emphasizes the age factor, we should also remember that age is only one data point in a shared decision making discussion. An athletic, fit woman in her mid-50s who participates in yoga and zumba four days a week in addition to resistance training is a very different patient than the sedentary, deconditioned woman of the same age.

In the discussion of what is best for each patient, we need to leverage our knowledge regarding the musculoskeletal problem coupled with the wisdom to consider each patient’s functional demands and goals for activity return. As our population ages and the level of older-patient fitness hopefully increases, these discussions will take more time, but will result in higher-quality decisions for the individual patient.

Marc Swiontkowski, MD

JBJS Editor-in-Chief


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