Table 2 Planned analysis of feasibility and clinical outcomes
Variable/outcome | Type of outcome | Hypothesis for surgical treatments | Hypothesis for biologic treatments | Outcome measures | Method of analysis |
|---|---|---|---|---|---|
Initiation of clinical sites | Feasibility | N/A | N/A | Reporting of locations and timelines of initiation | Count and percentage or mean and standard deviation or median and interquartile range |
Rate of participant enrolment | Feasibility | N/A | N/A | Number of participants enrolled | Count and percentage |
Rate of protocol adherence | Feasibility | N/A | N/A | Number of errors in randomization | Count and percentage |
Number of crossovers between SHS and cancellous screw treatment groups | |||||
Adherence to the daily vitamin D supplementation | |||||
Proportion of participants with complete follow-up at 12 months post-fracture | Feasibility | N/A | N/A | Number of participants who complete follow-up at 12 months post-fracture | Count and percentage |
Level of data quality | Feasibility | N/A | N/A | Completeness of data | Count and percentage |
Composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, nonunion) | Clinical | The risk of patient important outcomes will be lower in the SHS treatment arm compared to cancellous screw treatment arm | The risk of patient important outcomes will be lower in the vitamin D treatment arm than in the placebo arm | Unplanned re-operation related to the treatment of the femoral neck fracture anytime within 12 months | Cox regression |
Evidence of femoral head osteonecrosis on X-rays or MRI | |||||
Evidence of severe femoral neck malunion on X-rays (shortening of > 10 mm in any plane on follow-up X-rays) | |||||
Nonunion, defined as the failure of the fracture to progress towards healing defined as a RUSH score below 18 at 6 months or greater post-injury | |||||
Health-related quality of life and patient-reported function | Clinical | Health-related quality of life and patient-reported function will be better in the SHS treatment arm compared to cancellous screw treatment arm | Health-related quality of life and patient-reported function will be better in the vitamin D treatment arm than in the placebo arm | Short Form-12 (SF-12) and Hip Outcome Score (HOS) | T test |
Fracture healing complications | Clinical | Rates of fracture healing complications will be lower in the SHS treatment arm compared to cancellous screw treatment arm | Rates of fracture healing complications will be lower in the vitamin D treatment arm than in the placebo arm | Evidence of complications reported by patients or evident on X-rays | Cox regression |
Radiographic fracture healing | Clinical | Fractures will heal faster in the SHS treatment arm compared to cancellous screw treatment arm | Fractures will heal faster in the vitamin D treatment arm than in the placebo arm | Evidence of fracture healing on X-rays | Cox regression |