Internal Fixation Compared With Arthroplasty for Displaced Fractures of the Femoral Neck

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Background There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo 1 / Forsteo 1 , recombinant human parathyroid hormone) is a bone anabolic drug that is approved for treatment of osteoporosis and glucocorticoid-induced osteoporosis in men and postmenopausal women at high fracture risk. Preclinical and preliminary clinical data also suggest that teriparatide may enhance bone healing.Questions/purposes We wished to test the hypotheses that treatment with teriparatide versus placebo would improve femoral neck fracture healing after internal fixation as measured by (1) frequency of revision surgery, (2) radiographic fracture healing, and (3) other outcomes including pain control, gait speed, and safety. Methods We initiated two separate, but identically designed, clinical trials to meet FDA requirements to provide substantial evidence to support approval of a new indication. The two prospective, randomized double-blind, placebo-controlled Phase III studies were designed to evaluate the effect of subcutaneous teriparatide (20 lg/day) for 6 months versus placebo on fracture healing at 24 months. The trials were conducted concurrently with a planned enrollment of 1220 patients per trial. However, enrollment was stopped owing to very slow patient accrual, and an a priori decision was made to pool the results of those studies for statistical analyses before study completion; pooling was specified in both protocols. Randomization was stratified by fixation (sliding hip screw or multiple cancellous screws) and fracture type (displaced or nondisplaced). An independent Central Adjudication Committee reviewed revision surgical procedures and radiographs. A total of 159 patients were randomized in the two trials (81 placebo, 78 teriparatide). The combined program had very low power to detect the originally This study was sponsored by Eli Lilly and Company. The institutions of authors (MB, NG, RW) have received, during the study period, funding from Eli Lilly and Company. One author (MB), or a member of his or her immediate family, has or may receive payments or benefits, during the study period, an amount of less than USD 10,000 from Eli Lilly and Company. One or more of the authors (LJ, KS, RB, KDK, MRW, BM) are employees of Eli Lilly and Company, that provided funding for this study. One of the authors (QIA) was an employee of Eli Lilly and Company at the time of the study but he no longer is employed by them. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research 1 editors and board members are on file with the publication and can be viewed on request. Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained. This study was conducted at the authors' various institutions. Clinical Orthopaedics and Related Research ®A Publication of The ...

Section: Discussionsupporting

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial

Bhandari

Jin

See

et al. 2016

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“…If there is a difference in mortality between the methods, it would be an important factor in decision-making, even when including the functional benefits of treatment with hemiarthroplasty. No randomized study has reported a higher mortality rate after hemiarthroplasty [2,28], and it would require a very large study to conclude on this matter; Bhandari et al [2] estimated that demonstrating a 5% increased mortality rate would require a study sample size of 26,641 patients. Regarding mortality in this patient group overall, it is high the first year after fracture [20].…”

Section: Discussionmentioning

confidence: 99%

Randomized Trial of Hemiarthroplasty versus Internal Fixation for Femoral Neck Fractures: No Differences at 6 Years

Støen

Lofthus

Nordsletten

et al. 2014

Background Hemiarthroplasty has been shown superior to internal fixation for displaced femoral neck fractures (FNF) in the first 2 years. However, there are unanswered questions about the performance of hemiarthroplasty over the longer term compared with internal fixation. Questions/purposes We sought to compare hemiarthroplasty with internal fixation in terms of (1) outcomes scores for pain, hip function, and quality of life at a minimum of 5 years after surgery in a randomized trial. A secondary purpose was to compare (2) patient survival and (3) frequency of reoperation in the two groups. Methods A total of 222 consecutive patients older than 60 years, including those cognitively impaired, with FNF were randomized to either internal fixation with two parallel screws or bipolar hemiarthroplasty. At a minimum followup of 4.9 years (mean, 5.9 years; range, 4.9-7.2 years), 68 of the 70 surviving patients were examined by a study nurse and study physiotherapist blinded to initial treatment. Questionnaires on hip function (Harris hip score), quality of life (Eq5D), and activity of daily living function (Barthel ADL) were administered. The Barthel ADL index score was split into good function (score 95 or 100) and reduced function (score below 95).

“…In these instances, shared decision making must go beyond providing information to patients (evidence-based data on what could happen) to also receiving it from them (their preferences regarding the perhaps mutually exclusive outcome states). There are numerous orthopaedic clinical cases with an inherent tradeoff between desirable outcome states, including immediate versus delayed reconstruction for acute ruptures of the anterior cruciate ligament [11], arthroplasty versus internal fixation for treatment of displaced femoral neck fractures [4], arthroscopic versus open surgical repairs for management of anterior glenohumeral instability [17], and open reduction and internal fixation versus cast immobilization for nondisplaced or minimally displaced scaphoid fractures [6] (Table 1). In all these cases, the decision selected must be based on the relative values assigned to the possible outcomes; evidence-based medicine cannot, in the abstract, inform us of a universally correct (dominant) decision.…”

Section: Utility Rxà Dxàmentioning

confidence: 99%

The Variability of Patient Preferences

Bernstein

2012

BackgroundWide variation in procedure utilization suggests that surgical indications might not be rigorously defined. An alternative explanation is that surgical outcomes are valued differently across groups. When a patient, using the information provided by the surgeon, places high value on successful results or is indifferent to the costs of ineffective treatment, the treatment threshold is lower and more surgery will be chosen.