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Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2?×?2 factorial randomized controlled trial in young femoral neck fracture patients.

ABSTRACT: Background:Femoral neck fractures in patients ??60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial. Methods:We will conduct a multicenter, concealed randomized controlled pilot study, using a 2?×?2 factorial design in 60 patients aged 18-60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed. Discussion:Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations. Trial registration:The FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant.

SUBMITTER: FAITH-2 Investigators

PROVIDER: S-EPMC6540373 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients.

Slobogean Gerard P GP Sprague Sheila S Bzovsky Sofia S Heels-Ansdell Diane D Thabane Lehana L Scott Taryn T Bhandari Mohit M

Pilot and feasibility studies 20190528

<h4>Background</h4>Femoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus r ...[more]

PMID: 31161044

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Project description:BACKGROUND:Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. METHODS:For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a centralised computer system to receive a single large-diameter screw with a side-plate (sliding hip screw) or the present standard of care, multiple small-diameter cancellous screws. Surgeons and patients were not blinded but the data analyst, while doing the analyses, remained blinded to treatment groups. The primary outcome was hip reoperation within 24 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. Analyses followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT00761813. FINDINGS:Between March 3, 2008, and March 31, 2014, we randomly assigned 1108 patients to receive a sliding hip screw (n=557) or cancellous screws (n=551). Reoperations within 24 months did not differ by type of surgical fixation in those included in the primary analysis: 107 (20%) of 542 patients in the sliding hip screw group versus 117 (22%) of 537 patients in the cancellous screws group (hazard ratio [HR] 0·83, 95% CI 0·63-1·09; p=0·18). Avascular necrosis was more common in the sliding hip screw group than in the cancellous screws group (50 patients [9%] vs 28 patients [5%]; HR 1·91, 1·06-3·44; p=0·0319). However, no significant difference was found between the number of medically related adverse events between groups (p=0·82; appendix); these events included pulmonary embolism (two patients [<1%] vs four [1%] patients; p=0·41) and sepsis (seven [1%] vs six [1%]; p=0·79). INTERPRETATION:In terms of reoperation rates the sliding hip screw shows no advantage, but some groups of patients (smokers and those with displaced or base of neck fractures) might do better with a sliding hip screw than with cancellous screws. FUNDING:National Institutes of Health, Canadian Institutes of Health Research, Stichting NutsOhra, Netherlands Organisation for Health Research and Development, Physicians' Services Incorporated.

Project description:IntroductionHip arthroplasty (HA) is commonly performed to treat various hip pathologies. Its volume is expected to rise further due to the increasing age of the population. Complication rates are low; however, periprosthetic femoral fractures (PFF) are a rare, albeit serious, complication with substantial economic impact. While current guidelines propose revision with long-stemmed prostheses for all Vancouver B2 and B3 PFF, some recent research papers suggest that open reduction with internal fixation (ORIF) could lead to an equivalent outcome. Our aim was to summarize the evidence, elucidating under which circumstances ORIF leads to a favorable outcome after B2 and B3 PFF compared with revision surgery.Materials and methodsA systematic literature search was performed to identify studies on patients treated with ORIF and with stem revision after B2 and/or B3 fractures. Extracted information included initial pathology, stem fixation mechanism, bone quality and stem stability at the time of PFF, clinical outcomes, and mortality. Results of individual studies were summarized in a table in lieu of a quantitative data synthesis due to a lack of standardized information.ResultsWe identified 14 original research articles including both patients treated with ORIF and with stem revision after B2 and/or B3 PFF. Five studies included statistical comparisons, all were in favor of ORIF or indeterminate. The common lack of rigorous statistical analyses and significant methodological weaknesses made identification of outcome predictors impossible.ConclusionThe choice of treatment modality for PFF depends on fracture, implant, and bone characteristics. Recent data show that successful outcome can be achieved without revising loose stems. ORIF may be a viable option if bone stock is adequate around uncemented or tapered polished stems with an intact cement mantle and the fracture geometry allows stable anatomic reconstruction. Conceptional considerations support this idea, but more data are needed to identify outcome predictors.

Dataset Information

Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2?×?2 factorial randomized controlled trial in young femoral neck fracture patients.

Publications

Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients.

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