Femoral Neck Fractures
Conditions
Brief summary
The purpose of this study is to determine the impact of surgical fixation (cancellous screws versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient important outcomes.
Detailed description
Femoral neck fractures are a type of hip fracture associated with high complication rates and poor functional outcomes. It is estimated that over 300,000 hip fractures occur in patients under age 50 annually. Hip fractures in younger aged patients are particularly devastating with profound impairments of quality of life and function. Virtually all patients require surgical repair of their fractures and unlike elderly hip fractures, failure of surgery offers few options for salvage. Arthroplasty is a successful treatment for elderly patients; however, a hip replacement is not a viable option for younger patients because of their higher functional demands for work and recreational activities that are not tolerated by joint replacements. There is more than one way to perform internal fixation for femoral neck fractures. Cancellous screws have traditionally been the preferred internal fixation implant for femoral neck fractures. Multiple screws (2 or more) are used during fixation, and advocates of this implant promote the construct's superior torsional stability, limited disruption of femoral head blood supply, minimally invasive insertion, and retention of more viable bone than the larger sliding hip screw (SHS). On the other hand, sliding hip screws have been gaining popularity and there is evidence to suggest that SHS provide greater fracture stability and may reduce patient complications. It is currently unknown which method of internal fixation provides the best outcomes for patients. Femoral neck fracture treatment is further complicated by vitamin D insufficiency in as many as 8 of 10 trauma patients. Vitamin D plays an important role in musculoskeletal health and bone quality because it regulates serum calcium homeostasis. Laboratory research and human clinical studies suggest important associations between vitamin D, musculoskeletal health, and improved fracture healing. Experimental animal studies have demonstrated the concentration of vitamin D metabolites are higher at a fracture callus compared to the uninjured contralateral bone, vitamin D supplementation leads to decreased time to fracture union and increased callus vascularity, and vitamin D increases mechanical bone strength compared to controls. Clinical studies have also demonstrated that vitamin D supplementation increases the callus volume of proximal humerus fractures, increases the number and diameter of type II muscle fibres, and can improve wound healing, however, the effects of vitamin D supplementation in you patients with femoral neck fractures are unknown. Using a 2x2 factorial design, participant will be randomly allocated to one of four treatment arms. Participants allocated to the cancellous screw group will receive multiple threaded screws (with a minimum of 3 screws and a minimum diameter of 6.5 mm) and those allocated to the sliding hip screw group will receive a single larger diameter partially threaded screw affixed to the proximal femur with a sideplate using a minimum of 2 screws for fixation. Participants allocated to the vitamin D Group will receive a bottle of 2,000 International Units (IU) vitamin D3 drops. Participants will be instructed to take two drops daily for six months, for a total daily dose of 4,000 IU. Participants in the placebo group will receive an identical bottle of placebo drops with no active ingredient. Similarly, they will be instructed to take two drops daily for six months. All vitamin D3 supplement and placebo bottles will be labeled in a blinded manner according to Health Canada and Good Manufacturing Practice. Participation in this study will last 12 months. In-person participant follow-up visits will occur at enrollment (baseline), post-surgery, 6 weeks, 3 months, 6 months, 9 months, and 12 months post-surgery. Data for all outcomes and radiographs will be collected at each follow-up visit.
Interventions
Sponsors
Canadian Institutes of Health Research (CIHR)
McMaster Surgical Associates
Hamilton Health Sciences Corporation
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Adult men or women ages 18 to 60 years. 2. Fracture of the femoral neck. 3. Fracture amenable to both surgical treatments (SHS and cancellous screws). 4. Operative treatment within 7 days of injury. 5. Provision of informed consent by patient or substitute decision maker.
Exclusion criteria
1. Patients with previously diagnosed osteoporosis. 2. Fracture-dislocation of the femoral neck and hip joint. 3. Planned antegrade nailing of an ipsilateral femoral shaft fracture (if present). 4. Current infection around the hip (i.e. soft tissue or bone). 5. Stress fracture of the femoral neck. 6. Pathologic fractures secondary to neoplasm or other bone lesion. 7. Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfect, etc. 8. Patients with hyperhomocysteinemia. 9. Patient has an allergy to vitamin D or another contraindication to being prescribed vitamin D. 10. Patient is currently taking an over counter drug and/or food supplement that contains vitamin D and is unable or unwilling to discontinue its use for this study. 11. Likely problems, in the judgment of the attending surgeon, with maintaining follow up (e.g. patients with no fixed address, plans to move out of town). This may include patients with severe mental disorders and drug addictions without adequate support. 12. Pregnancy. 13. Patient is incarcerated. 14. Patient is not expected to survive injuries. 15. The attending surgeon believes the patient should be excluded because they are involved in a conflicting clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Patient Important Outcomes | 12 months post-surgery | A participant met the primary clinical endpoint if they experienced one or more of the four outcomes: 1. Re-operation: any unplanned surgery related to the treatment of the femoral neck fracture; 2. Femoral head osteonecrosis: any evidence of osteonecrosis on any follow-up medical imaging study (i.e., radiographs, magnetic resonance imaging (MRI), or other advanced imaging study); 3. Severe femoral neck malunion: fracture healing with femoral neck shortening of \>10 mm in any plane on follow-up x-rays; or 4. Nonunion: failure of the fracture to progress towards healing defined as a Radiographic Union Score for Hip (RUSH) score below a pre-determined threshold specific for nonunion at 6 months or greater post-injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-12 (SF-12) Physical Composite Scale (PCS) | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The SF-12 is a 12-item questionnaire that measures self-reported quality of life through an 8-domain profile of functional health and well-being, physical and mental health summary measures and a preference-based health utility index. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
| Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The SF-12 is a 12-item questionnaire that measures self-reported quali... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
| Number of Participants With Non-Operatively-Treated Fracture Healing Complications | 12 months post-surgery | Fracture healing complications treated non-operatively are presented in this table and included wound healing problems, infection (superficial and deep), hardware failure, hardware breakage, painful hardware, and peri-prosthetic fracture. |
| Hip Outcome Score (HOS) Sports Scale | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function). |
| Radiographic Fracture Healing | up to 12 months post-surgery | The date of healing will be determined by the Central Adjudication Committee (CAC). They will consider a fracture as healed when there is obliteration of the fracture line by newly formed bone along the cortices and within the trabecular bone on anterior-posterior and lateral radiographs. |
| Hip Outcome Score (HOS) Activities of Daily Living Scale | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function). |
Countries
Australia, Canada, United States
Participant flow
Pre-assignment details
91 patients were enrolled into the FAITH-2 pilot trial. Five of these enrolments were subsequently determined to be ineligible (not between the ages of 18-60 years, pathological fracture, no femoral neck fracture, did not provide informed consent (2 patients)). Therefore, 86 participants were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Sliding Hip Screw + Vitamin D Supplementation Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU. | 22 |
| Cancellous Screws + Vitamin D Supplementation Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group received a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants were instructed to take two drops daily for six months, for a total daily dose of 4,000 IU. | 23 |
| Sliding Hip Screw + Vitamin D Placebo Participants allocated to this group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company. | 21 |
| Cancellous Screws + Vitamin D Placebo Participants allocated to this group received multiple cancellous screws with a minimum diameter of 6.5 mm and were given an identical bottle of placebo drops with no active ingredient. Similarly, they were instructed to take two drops daily for six months. The placebo supplement was also manufactured by the Ddrops Company. | 20 |
| Total | 86 |
Baseline characteristics
| Characteristic | Sliding Hip Screw + Vitamin D Supplementation | Cancellous Screws + Vitamin D Supplementation | Sliding Hip Screw + Vitamin D Placebo | Cancellous Screws + Vitamin D Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 11.2 | 40.3 years STANDARD_DEVIATION 13 | 45.2 years STANDARD_DEVIATION 11.5 | 37.9 years STANDARD_DEVIATION 13.7 | 41.1 years STANDARD_DEVIATION 12.4 |
| Race/Ethnicity, Customized Black | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Indigenous | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Mixed (Black & White) | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized South Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Southeast Asian (Filipino) | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 19 Participants | 18 Participants | 17 Participants | 68 Participants |
| Region of Enrollment Canada | 7 participants | 7 participants | 7 participants | 7 participants | 28 participants |
| Region of Enrollment United States | 15 participants | 16 participants | 14 participants | 13 participants | 58 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 8 Participants | 3 Participants | 23 Participants |
| Sex: Female, Male Male | 17 Participants | 16 Participants | 13 Participants | 17 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 | 0 / 21 | 0 / 20 |
| other Total, other adverse events | 2 / 22 | 3 / 23 | 3 / 21 | 3 / 20 |
| serious Total, serious adverse events | 5 / 22 | 6 / 23 | 9 / 21 | 5 / 20 |
Outcome results
Primary
Number of Participants With Patient Important Outcomes
A participant met the primary clinical endpoint if they experienced one or more of the four outcomes: 1. Re-operation: any unplanned surgery related to the treatment of the femoral neck fracture; 2. Femoral head osteonecrosis: any evidence of osteonecrosis on any follow-up medical imaging study (i.e., radiographs, magnetic resonance imaging (MRI), or other advanced imaging study); 3. Severe femoral neck malunion: fracture healing with femoral neck shortening of \>10 mm in any plane on follow-up x-rays; or 4. Nonunion: failure of the fracture to progress towards healing defined as a Radiographic Union Score for Hip (RUSH) score below a pre-determined threshold specific for nonunion at 6 months or greater post-injury.
Time frame: 12 months post-surgery
Population: 91 patients were randomized into the FAITH-2 pilot trial. 86 patients were deemed eligible and included in the analyses. Of the 86 participants, 43 were allocated to receive a sliding hip screw and 43 were allocated to receive CS. Regarding supplementation treatment, 45 were allocated to receive vitamin D, and 41 were allocated to receive placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sliding Hip Screw | Number of Participants With Patient Important Outcomes | Severe femoral neck malunion | 2 Participants |
| Sliding Hip Screw | Number of Participants With Patient Important Outcomes | Re-operation | 9 Participants |
| Sliding Hip Screw | Number of Participants With Patient Important Outcomes | Nonunion | 4 Participants |
| Sliding Hip Screw | Number of Participants With Patient Important Outcomes | Femoral head osteonecrosis | 2 Participants |
| Sliding Hip Screw | Number of Participants With Patient Important Outcomes | Primary Clinical Endpoint | 11 Participants |
| Cancellous Screws | Number of Participants With Patient Important Outcomes | Femoral head osteonecrosis | 7 Participants |
| Cancellous Screws | Number of Participants With Patient Important Outcomes | Severe femoral neck malunion | 6 Participants |
| Cancellous Screws | Number of Participants With Patient Important Outcomes | Nonunion | 3 Participants |
| Cancellous Screws | Number of Participants With Patient Important Outcomes | Re-operation | 6 Participants |
| Cancellous Screws | Number of Participants With Patient Important Outcomes | Primary Clinical Endpoint | 13 Participants |
| Vitamin D Supplementation | Number of Participants With Patient Important Outcomes | Femoral head osteonecrosis | 5 Participants |
| Vitamin D Supplementation | Number of Participants With Patient Important Outcomes | Primary Clinical Endpoint | 11 Participants |
| Vitamin D Supplementation | Number of Participants With Patient Important Outcomes | Re-operation | 7 Participants |
| Vitamin D Supplementation | Number of Participants With Patient Important Outcomes | Severe femoral neck malunion | 5 Participants |
| Vitamin D Supplementation | Number of Participants With Patient Important Outcomes | Nonunion | 4 Participants |
| Vitamin D Placebo | Number of Participants With Patient Important Outcomes | Severe femoral neck malunion | 3 Participants |
| Vitamin D Placebo | Number of Participants With Patient Important Outcomes | Re-operation | 8 Participants |
| Vitamin D Placebo | Number of Participants With Patient Important Outcomes | Primary Clinical Endpoint | 13 Participants |
| Vitamin D Placebo | Number of Participants With Patient Important Outcomes | Femoral head osteonecrosis | 4 Participants |
| Vitamin D Placebo | Number of Participants With Patient Important Outcomes | Nonunion | 3 Participants |
Secondary
Hip Outcome Score (HOS) Activities of Daily Living Scale
The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function).
Time frame: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Population: 91 patients were randomized into the FAITH-2 pilot trial. 86 patients were deemed eligible and included in the analyses. Of the 86 participants, 43 were allocated to receive a sliding hip screw and 43 were allocated to receive CS. Regarding supplementation treatment, 45 were allocated to receive vitamin D, and 41 were allocated to receive placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sliding Hip Screw | Hip Outcome Score (HOS) Activities of Daily Living Scale | Pre-fracture | 89.2 scores on a scale | Standard Deviation 20.4 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Weeks | 39.1 scores on a scale | Standard Deviation 19.5 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Activities of Daily Living Scale | 3 Months | 56.8 scores on a scale | Standard Deviation 24.1 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Months | 64.5 scores on a scale | Standard Deviation 24.4 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Activities of Daily Living Scale | 9 Months | 69.0 scores on a scale | Standard Deviation 21.1 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Activities of Daily Living Scale | 12 Months | 73.0 scores on a scale | Standard Deviation 22.7 |
| Cancellous Screws | Hip Outcome Score (HOS) Activities of Daily Living Scale | 12 Months | 79.4 scores on a scale | Standard Deviation 22.7 |
| Cancellous Screws | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Months | 74.4 scores on a scale | Standard Deviation 23.1 |
| Cancellous Screws | Hip Outcome Score (HOS) Activities of Daily Living Scale | Pre-fracture | 95.4 scores on a scale | Standard Deviation 14.8 |
| Cancellous Screws | Hip Outcome Score (HOS) Activities of Daily Living Scale | 3 Months | 59.3 scores on a scale | Standard Deviation 25.5 |
| Cancellous Screws | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Weeks | 36.1 scores on a scale | Standard Deviation 23.1 |
| Cancellous Screws | Hip Outcome Score (HOS) Activities of Daily Living Scale | 9 Months | 79.6 scores on a scale | Standard Deviation 22.4 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Weeks | 38.1 scores on a scale | Standard Deviation 23.1 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Activities of Daily Living Scale | 3 Months | 56.7 scores on a scale | Standard Deviation 25.4 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Months | 69.7 scores on a scale | Standard Deviation 23.8 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Activities of Daily Living Scale | 12 Months | 76.6 scores on a scale | Standard Deviation 21.5 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Activities of Daily Living Scale | 9 Months | 75.1 scores on a scale | Standard Deviation 23.2 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Activities of Daily Living Scale | Pre-fracture | 93.1 scores on a scale | Standard Deviation 18.3 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Activities of Daily Living Scale | 9 Months | 74.7 scores on a scale | Standard Deviation 21.4 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Activities of Daily Living Scale | 12 Months | 76.2 scores on a scale | Standard Deviation 23.5 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Weeks | 37.1 scores on a scale | Standard Deviation 19 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Activities of Daily Living Scale | 6 Months | 69.6 scores on a scale | Standard Deviation 25 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Activities of Daily Living Scale | Pre-fracture | 91.5 scores on a scale | Standard Deviation 17.7 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Activities of Daily Living Scale | 3 Months | 59.8 scores on a scale | Standard Deviation 23.7 |
Secondary
Hip Outcome Score (HOS) Sports Scale
The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function).
Time frame: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Population: 91 patients were randomized into the FAITH-2 pilot trial. 86 patients were deemed eligible and included in the analyses. Of the 86 participants, 43 were allocated to receive a sliding hip screw and 43 were allocated to receive CS. Regarding supplementation treatment, 45 were allocated to receive vitamin D, and 41 were allocated to receive placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sliding Hip Screw | Hip Outcome Score (HOS) Sports Scale | 9 Months | 42.8 scores on a scale | Standard Deviation 33.9 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Sports Scale | 6 Weeks | 9.3 scores on a scale | Standard Deviation 14.9 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Sports Scale | 12 Months | 47.5 scores on a scale | Standard Deviation 31 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Sports Scale | 3 Months | 20.8 scores on a scale | Standard Deviation 22.9 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Sports Scale | 6 Months | 33.0 scores on a scale | Standard Deviation 31 |
| Sliding Hip Screw | Hip Outcome Score (HOS) Sports Scale | Pre-fracture | 78.5 scores on a scale | Standard Deviation 33.5 |
| Cancellous Screws | Hip Outcome Score (HOS) Sports Scale | 6 Weeks | 8.0 scores on a scale | Standard Deviation 13.4 |
| Cancellous Screws | Hip Outcome Score (HOS) Sports Scale | Pre-fracture | 86.9 scores on a scale | Standard Deviation 25.9 |
| Cancellous Screws | Hip Outcome Score (HOS) Sports Scale | 3 Months | 21.4 scores on a scale | Standard Deviation 25.1 |
| Cancellous Screws | Hip Outcome Score (HOS) Sports Scale | 9 Months | 54.8 scores on a scale | Standard Deviation 28.7 |
| Cancellous Screws | Hip Outcome Score (HOS) Sports Scale | 12 Months | 57.3 scores on a scale | Standard Deviation 31.4 |
| Cancellous Screws | Hip Outcome Score (HOS) Sports Scale | 6 Months | 45.1 scores on a scale | Standard Deviation 28.7 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Sports Scale | Pre-fracture | 88.6 scores on a scale | Standard Deviation 25.5 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Sports Scale | 6 Weeks | 8.0 scores on a scale | Standard Deviation 13.7 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Sports Scale | 9 Months | 52.4 scores on a scale | Standard Deviation 33 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Sports Scale | 6 Months | 38.1 scores on a scale | Standard Deviation 30.7 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Sports Scale | 12 Months | 52.4 scores on a scale | Standard Deviation 33.4 |
| Vitamin D Supplementation | Hip Outcome Score (HOS) Sports Scale | 3 Months | 20.1 scores on a scale | Standard Deviation 23.8 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Sports Scale | 12 Months | 53.1 scores on a scale | Standard Deviation 29.6 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Sports Scale | Pre-fracture | 76.4 scores on a scale | Standard Deviation 33.3 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Sports Scale | 6 Weeks | 9.4 scores on a scale | Standard Deviation 14.7 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Sports Scale | 3 Months | 22.2 scores on a scale | Standard Deviation 23.9 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Sports Scale | 6 Months | 41.0 scores on a scale | Standard Deviation 29.5 |
| Vitamin D Placebo | Hip Outcome Score (HOS) Sports Scale | 9 Months | 45.6 scores on a scale | Standard Deviation 29.2 |
Secondary
Number of Participants With Non-Operatively-Treated Fracture Healing Complications
Fracture healing complications treated non-operatively are presented in this table and included wound healing problems, infection (superficial and deep), hardware failure, hardware breakage, painful hardware, and peri-prosthetic fracture.
Time frame: 12 months post-surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sliding Hip Screw | Number of Participants With Non-Operatively-Treated Fracture Healing Complications | 0 Participants |
| Cancellous Screws | Number of Participants With Non-Operatively-Treated Fracture Healing Complications | 1 Participants |
| Vitamin D Supplementation | Number of Participants With Non-Operatively-Treated Fracture Healing Complications | 0 Participants |
| Vitamin D Placebo | Number of Participants With Non-Operatively-Treated Fracture Healing Complications | 0 Participants |
Secondary
Radiographic Fracture Healing
The date of healing will be determined by the Central Adjudication Committee (CAC). They will consider a fracture as healed when there is obliteration of the fracture line by newly formed bone along the cortices and within the trabecular bone on anterior-posterior and lateral radiographs.
Time frame: up to 12 months post-surgery
Population: 91 patients were randomized into the FAITH-2 pilot trial. 86 patients were deemed eligible and included in the analyses. Of the 86 participants, 43 were allocated to receive a sliding hip screw and 43 were allocated to receive CS. Regarding supplementation treatment, 45 were allocated to receive vitamin D, and 41 were allocated to receive placebo.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sliding Hip Screw | Radiographic Fracture Healing | 224.0 days | Standard Deviation 131.5 |
| Cancellous Screws | Radiographic Fracture Healing | 236.7 days | Standard Deviation 136.7 |
| Vitamin D Supplementation | Radiographic Fracture Healing | 210.4 days | Standard Deviation 121 |
| Vitamin D Placebo | Radiographic Fracture Healing | 252.3 days | Standard Deviation 144.2 |
Secondary
Short Form-12 (SF-12) Mental Health Composite Scale (MCS)
The SF-12 is a 12-item questionnaire that measures self-reported quali... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Population: 91 patients were randomized into the FAITH-2 pilot trial. 86 patients were deemed eligible and included in the analyses. Of the 86 participants, 43 were allocated to receive a sliding hip screw and 43 were allocated to receive CS. Regarding supplementation treatment, 45 were allocated to receive vitamin D, and 41 were allocated to receive placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sliding Hip Screw | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | Pre-fracture | 55.6 scores on a scale | Standard Deviation 8.1 |
| Sliding Hip Screw | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Weeks | 52.0 scores on a scale | Standard Deviation 11.5 |
| Sliding Hip Screw | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 3 Months | 50.5 scores on a scale | Standard Deviation 13.2 |
| Sliding Hip Screw | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Months | 55.0 scores on a scale | Standard Deviation 9.9 |
| Sliding Hip Screw | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 9 Months | 54.0 scores on a scale | Standard Deviation 9.7 |
| Sliding Hip Screw | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 12 Months | 52.9 scores on a scale | Standard Deviation 9.8 |
| Cancellous Screws | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 12 Months | 53.3 scores on a scale | Standard Deviation 9.2 |
| Cancellous Screws | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Months | 54.2 scores on a scale | Standard Deviation 8.6 |
| Cancellous Screws | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | Pre-fracture | 53.1 scores on a scale | Standard Deviation 8.3 |
| Cancellous Screws | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 3 Months | 54.3 scores on a scale | Standard Deviation 10.1 |
| Cancellous Screws | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Weeks | 53.9 scores on a scale | Standard Deviation 9.9 |
| Cancellous Screws | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 9 Months | 54.0 scores on a scale | Standard Deviation 9.9 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Weeks | 53.0 scores on a scale | Standard Deviation 9.8 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 3 Months | 54.4 scores on a scale | Standard Deviation 10.3 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Months | 52.9 scores on a scale | Standard Deviation 8.2 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 12 Months | 52.4 scores on a scale | Standard Deviation 9.3 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 9 Months | 53.8 scores on a scale | Standard Deviation 10 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | Pre-fracture | 54.3 scores on a scale | Standard Deviation 7.6 |
| Vitamin D Placebo | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 9 Months | 54.3 scores on a scale | Standard Deviation 9.5 |
| Vitamin D Placebo | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 12 Months | 53.9 scores on a scale | Standard Deviation 9.6 |
| Vitamin D Placebo | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Weeks | 52.9 scores on a scale | Standard Deviation 11.8 |
| Vitamin D Placebo | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 6 Months | 57.0 scores on a scale | Standard Deviation 10.2 |
| Vitamin D Placebo | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | Pre-fracture | 54.2 scores on a scale | Standard Deviation 9 |
| Vitamin D Placebo | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | 3 Months | 50.1 scores on a scale | Standard Deviation 13.2 |
Secondary
Short Form-12 (SF-12) Physical Composite Scale (PCS)
The SF-12 is a 12-item questionnaire that measures self-reported quality of life through an 8-domain profile of functional health and well-being, physical and mental health summary measures and a preference-based health utility index. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Time frame: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Population: 91 patients were randomized into the FAITH-2 pilot trial. 86 patients were deemed eligible and included in the analyses. Of the 86 participants, 43 were allocated to receive a sliding hip screw and 43 were allocated to receive CS. Regarding supplementation treatment, 45 were allocated to receive vitamin D, and 41 were allocated to receive placebo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sliding Hip Screw | Short Form-12 (SF-12) Physical Composite Scale (PCS) | Pre-fracture | 50.5 scores on a scale | Standard Deviation 10.4 |
| Sliding Hip Screw | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Weeks | 29.9 scores on a scale | Standard Deviation 8.5 |
| Sliding Hip Screw | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 3 Months | 36.2 scores on a scale | Standard Deviation 11.2 |
| Sliding Hip Screw | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Months | 36.9 scores on a scale | Standard Deviation 11.5 |
| Sliding Hip Screw | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 9 Months | 38.3 scores on a scale | Standard Deviation 12.8 |
| Sliding Hip Screw | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 12 Months | 42.2 scores on a scale | Standard Deviation 12.4 |
| Cancellous Screws | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 12 Months | 45.0 scores on a scale | Standard Deviation 11.6 |
| Cancellous Screws | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Months | 43.4 scores on a scale | Standard Deviation 13 |
| Cancellous Screws | Short Form-12 (SF-12) Physical Composite Scale (PCS) | Pre-fracture | 53.7 scores on a scale | Standard Deviation 7.1 |
| Cancellous Screws | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 3 Months | 36.7 scores on a scale | Standard Deviation 10.7 |
| Cancellous Screws | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Weeks | 29.3 scores on a scale | Standard Deviation 10.2 |
| Cancellous Screws | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 9 Months | 45.0 scores on a scale | Standard Deviation 13.2 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Weeks | 29.7 scores on a scale | Standard Deviation 9.6 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 3 Months | 37.2 scores on a scale | Standard Deviation 12 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Months | 41.4 scores on a scale | Standard Deviation 12.9 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 12 Months | 44.5 scores on a scale | Standard Deviation 10.9 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 9 Months | 41.8 scores on a scale | Standard Deviation 14 |
| Vitamin D Supplementation | Short Form-12 (SF-12) Physical Composite Scale (PCS) | Pre-fracture | 53.5 scores on a scale | Standard Deviation 7.1 |
| Vitamin D Placebo | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 9 Months | 42.4 scores on a scale | Standard Deviation 12.5 |
| Vitamin D Placebo | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 12 Months | 42.6 scores on a scale | Standard Deviation 13.3 |
| Vitamin D Placebo | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Weeks | 29.4 scores on a scale | Standard Deviation 9.2 |
| Vitamin D Placebo | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 6 Months | 38.8 scores on a scale | Standard Deviation 12.4 |
| Vitamin D Placebo | Short Form-12 (SF-12) Physical Composite Scale (PCS) | Pre-fracture | 50.8 scores on a scale | Standard Deviation 10.5 |
| Vitamin D Placebo | Short Form-12 (SF-12) Physical Composite Scale (PCS) | 3 Months | 35.7 scores on a scale | Standard Deviation 9.5 |