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The FAITH and HEALTH Trials: Are We Studying Different Hip Fracture Patient Populations?
Michael Blankstein1, Emil H Schemitsch, Sofia Bzovsky
1aDepartment of Orthopaedics and Rehabilitation, University of Vermont Medical Center, South Burlington, VT; bDepartment of Surgery, University of Western Ontario, London, ON, Canada; cDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; dDepartment of Orthopedic and Trauma Surgery, OLVG, Amsterdam and Leiden University Medical Center, Leiden, the Netherlands; eDivision of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway; fDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; and gDepartment of Orthopaedic Surgery, University of Minnesota, Minneapolis, MN.
Background:
Over the past decade, 2 randomized controlled trials were performed to evaluate 2 surgical strategies (internal fixation and arthroplasty) for the treatment of low-energy femoral neck fractures in patients aged ≥50 years. We evaluated whether patient populations in both the FAITH and HEALTH trials had different baseline characteristics and compared the displaced femoral neck fracture cohort from the FAITH trial to HEALTH trial patients.
Methods:
Patient demographics, medical comorbidities, and fracture characteristics from both trials were compared. FAITH trial patients with displaced fractures were then compared with HEALTH patients. T-tests and χ tests were performed to compare differences for sex, age, osteoporosis status, and ASA class.
Results:
The mean age of the 1079 FAITH trial patients was 72 versus 79 years for the 1441 HEALTH trial patients. HEALTH patients were older, mostly White, used more medication, and had more comorbidities than FAITH patients. Of the 1079 FAITH trial patients, 32% (346/1079) had displaced fractures. Their mean age was significantly lower than that of HEALTH patients (66 vs. 79 years; P < 0.001). HEALTH trial patients were significantly more likely to be female, have ASA classification Class III/IV/V, and carry a diagnosis of osteoporosis, as compared with the subgroup of FAITH patients with displaced femoral neck fractures (P < 0.001).
Conclusion:
This study demonstrates significant differences between patients enrolled in the 2 trials. Although both studies focused on femoral neck fractures with similar enrollment criteria, patient populations differed. This sheds light on a noteworthy limitation of discordant patient enrollment into randomized trials, despite similar eligibility criteria.
Level Of Evidence:
Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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