Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Slobogean, Gerard P.; Sprague, Sheila; Bzovsky, Sofia; Scott, Taryn; Thabane, Lehana; Heels‐Ansdell, Diane; O’Toole, Robert V.; Howe, Andrea; Gaski, Greg E.; Hill, Lauren C.; Brown, Krista; Viskontas, Darius; Zomar, Mauri; Rocca, Gregory J. Della; Bhandari, Mohit; Investigators, Faith

doi:10.1097/bot.0000000000001773

Cited by 11 publications

(31 citation statements)

References 28 publications

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“…Overall, our results appear largely consistent with a mounting body of vitamin D research questioning previously hypothesized benefits of vitamin D supplementation for nonskeletal pathology. ( 26, 31–35 ) However, our post hoc analyses suggest high doses of vitamin D 3 might confer a modest benefit in clinical fracture healing, but this result requires confirmation in a larger RCT.…”

Section: Discussionmentioning

confidence: 87%

“…Among patients with ipsilateral femoral shaft fractures, the FAITH‐2 results detected no differences in the average time to radiographic femoral shaft healing between the groups ( p = 0.52). ( 26 ) Furthermore, vitamin D supplementation did not reduce the risk of other patient‐important complications associated with fracture healing. ( 26 )…”

Section: Discussionmentioning

confidence: 99%

“…( 26 ) Furthermore, vitamin D supplementation did not reduce the risk of other patient‐important complications associated with fracture healing. ( 26 )…”

Section: Discussionmentioning

confidence: 99%

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Effect of Vitamin D₃ Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial

et al. 2022

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Nearly half of adult fracture patients are vitamin D deficient (serum 25‐hydroxyvitamin D [25(OH)D] levels <20 ng/mL). Many surgeons advocate prescribing vitamin D supplements to improve fracture healing outcomes; however, data supporting the effectiveness of vitamin D 3 supplements to improve acute fracture healing are lacking. We tested the effectiveness of vitamin D 3 supplementation for improving tibia and femur fracture healing. We conducted a single‐center, double ‐ blinded phase II screening randomized controlled trial with a 12‐month follow‐up. Patients aged 18–50 years receiving an intramedullary nail for a tibia or femoral shaft fracture were randomized 1:1:1:1 to receive (i) 150,000 IU loading dose vitamin D 3 at injury and 6 weeks ( n = 27); (ii) 4000 IU vitamin D 3 daily ( n = 24); (iii) 600 IU vitamin D 3 daily ( n = 24); or (iv) placebo ( n = 27). Primary outcomes were clinical fracture healing (Function IndeX for Trauma [FIX‐IT]) and radiographic fracture healing (Radiographic Union Score for Tibial fractures [RUST]) at 3 months. One hundred two patients with a mean age of 29 years (standard deviation 8) were randomized. The majority were male (69%), and 56% were vitamin D 3 deficient at baseline . Ninety‐nine patients completed the 3‐month follow‐up. In our prespecified comparisons, no clinically important or statistically significant differences were detected in RUST or FIX‐IT scores between groups when measured at 3 months and over 12 months. However, in a post hoc comparison, high doses of vitamin D 3 were associated with improved clinical fracture healing relative to placebo at 3 months (mean difference [MD] 0.90, 80% confidence interval [CI], 0.08 to 1.79; p = 0.16) and within 12 months (MD 0.89, 80% CI, 0.05 to 1.74; p = 0.18). The study was designed to identify potential evidence to support the effectiveness of vitamin D 3 supplementation in improving acute fracture healing. Vitamin D 3 supplementation, particularly high doses, might modestly improve acute tibia or femoral shaft fracture healing in healthy adults, but confirmatory studies are required. The Vita‐Shock trial was awarded the Orthopaedic Trauma Association's (OTA) Bovill Award in 2020. This award is presented annually to the authors of the most outstanding OTA Annual Meeting scientific paper. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

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Section: Discussionmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

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Effect of Vitamin D₃ Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial

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“…After enrolling 91 participants in the pilot trial, it was determined a definitive trial would not be feasible [6] . A subsequent analysis of the primary clinical outcome, a composite of fracture-related complications, failed to identify any differences in complications between the surgical and vitamin D treatment groups within the limited sample size [7] . Despite being underpowered for the primary clinical outcome comparison at 12-months, we sought to determine if differences in hip function and HRQL would exist between the treatment groups.…”

Section: Introductionmentioning

confidence: 98%

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Slobogean¹,

Sprague²,

Bzovsky³

et al. 2021

Injury

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Results: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6-and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment.Conclusions: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional effort s to improve the outcomes of these challenging injuries are still needed.

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“…Details of the primary and secondary clinical outcomes of the FAITH-2 pilot trial will be reported separately. [ 10 ]…”

Section: Introductionmentioning

confidence: 99%

Fixation Using Alternative Implants for the Treatment of Hip Fractures

Sprague¹,

Bhandari²,

Bzovsky³

et al. 2020

OTA International: The Open Access Journal of Orthopaedic Trauma

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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.

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Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Cited by 11 publications

References 28 publications

Effect of Vitamin D₃ Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial

Effect of Vitamin D₃ Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Fixation Using Alternative Implants for the Treatment of Hip Fractures

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Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Cited by 11 publications

References 28 publications

Effect of Vitamin D3 Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial

Effect of Vitamin D3 Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients

Fixation Using Alternative Implants for the Treatment of Hip Fractures

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Effect of Vitamin D₃ Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial

Effect of Vitamin D₃ Supplementation on Acute Fracture Healing: A Phase II Screening Randomized Double‐Blind Controlled Trial