Dataset Information

Fixation Using Alternative Implants for the Treatment of Hip Fractures: The feasibility of a multicenter 2 × 2 factorial randomized controlled trial evaluating surgical treatment and vitamin D supplementation in young femoral neck fracture patients.

ABSTRACT:

Objectives

To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial.

Design

Pilot trial.

Setting

Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites.

Patients/participants

Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation.

Intervention

Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture.

Main outcome measurements

Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence).

Results

Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months.

Conclusions

Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.

SUBMITTER: Sprague S

PROVIDER: S-EPMC8022909 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundFemoral 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.MethodsWe 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.DiscussionResults 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 registrationThe FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant.

Project description:To compare the static and dynamic mechanical properties of a modified crossed cannulated screw (CS) configuration, the inverted triangle (IT) cannulated screw configuration, and a compression hip screw (CHS) with derotation screw in Pauwels type III femoral neck fractures.Thirty synthetic femora were divided into 3 groups, and vertical femoral neck osteotomies were made. Ten osteotomized femora were fixed with a CS configuration, 10 were fixed with 3 parallel screws in an IT configuration, and the remaining 10 osteotomized femora were fixed with a CHS construct. All groups were tested using a cyclic (up to 15,000 load cycles) axial loading protocol, and survivors were statically loaded to failure. Cycles to failure, load to failure, and stiffness were calculated. The Kaplan-Meier method was used to estimate survival functions and were compared among fixation methods. The relationship between construct structural properties (maximum load and stiffness) and treatment were assessed using general linear modeling.All CHS fixation constructs survived the 15,000 cycle loading protocol. They endured longer (P = 0.034) than the CS fixation constructs (mean failure 13,332 cycles), but were not different from IT fixation constructs (mean failure 13,592 cycles). Maximum loads to failure for CS (3870 N) and IT (3756 N) fixation constructs were not different, but were less (P < 0.0001) than the maximum loads to failure for the CHS fixation constructs (5654 N). These findings parallel the results of the axial stiffness measurements: CS fixation constructs (663.01 N/mm) were not stiffer than IT fixation constructs (620.0 N/mm), but were less (P = 0.0005) than the axial stiffness of the CHS fixation constructs (1241.86 N/mm).The biomechanical performance of the CHS fixation method was superior to both the CS fixation method and the IT fixation method using a synthetic femoral model and this test protocol. Biomechanical performance of the latter 2 groups was indistinguishable. We recommend the use of CHS with the derotational screw construct for Pauwels III femoral neck fractures whenever possible.