Trial Outcomes & Findings for Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) (NCT NCT01908751)

NCT ID: NCT01908751

Last Updated: 2020-11-30

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

91 participants

Primary outcome timeframe

12 months post-surgery

Results posted on

2020-11-30

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Overall Study STARTED	23	21	20	22
Overall Study COMPLETED	18	16	16	17
Overall Study NOT COMPLETED	5	5	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sliding Hip Screw + Vitamin D Supplementation n=22 Participants 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.	Cancellous Screws + Vitamin D Supplementation n=23 Participants 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.	Sliding Hip Screw + Vitamin D Placebo n=21 Participants 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.	Cancellous Screws + Vitamin D Placebo n=20 Participants 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.	Total n=86 Participants Total of all reporting groups
Age, Continuous	41.0 years STANDARD_DEVIATION 11.2 • n=5 Participants	40.3 years STANDARD_DEVIATION 13.0 • n=7 Participants	45.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	37.9 years STANDARD_DEVIATION 13.7 • n=4 Participants	41.1 years STANDARD_DEVIATION 12.4 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	3 Participants n=4 Participants	23 Participants n=21 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	17 Participants n=4 Participants	63 Participants n=21 Participants
Race/Ethnicity, Customized Indigenous	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized South Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Southeast Asian (Filipino)	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	68 Participants n=21 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Race/Ethnicity, Customized Mixed (Black & White)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Middle Eastern	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Canada	7 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants	7 participants n=4 Participants	28 participants n=21 Participants
Region of Enrollment United States	15 participants n=5 Participants	16 participants n=7 Participants	14 participants n=5 Participants	13 participants n=4 Participants	58 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sliding Hip Screw n=43 Participants Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.	Cancellous Screws n=43 Participants Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.	Vitamin D Supplementation n=45 Participants Participants allocated to the vitamin D Group 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.	Vitamin D Placebo n=41 Participants Participants in the placebo group received 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.
Number of Participants With Patient Important Outcomes Primary Clinical Endpoint	11 Participants	13 Participants	11 Participants	13 Participants
Number of Participants With Patient Important Outcomes Re-operation	9 Participants	6 Participants	7 Participants	8 Participants
Number of Participants With Patient Important Outcomes Femoral head osteonecrosis	2 Participants	7 Participants	5 Participants	4 Participants
Number of Participants With Patient Important Outcomes Severe femoral neck malunion	2 Participants	6 Participants	5 Participants	3 Participants
Number of Participants With Patient Important Outcomes Nonunion	4 Participants	3 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sliding Hip Screw n=43 Participants Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.	Cancellous Screws n=43 Participants Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.	Vitamin D Supplementation n=45 Participants Participants allocated to the vitamin D Group 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.	Vitamin D Placebo n=41 Participants Participants in the placebo group received 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.
Number of Participants With Non-Operatively-Treated Fracture Healing Complications	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sliding Hip Screw n=43 Participants Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.	Cancellous Screws n=43 Participants Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.	Vitamin D Supplementation n=45 Participants Participants allocated to the vitamin D Group 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.	Vitamin D Placebo n=41 Participants Participants in the placebo group received 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.
Short Form-12 (SF-12) Physical Composite Scale (PCS) Pre-fracture	50.5 scores on a scale Standard Deviation 10.4	53.7 scores on a scale Standard Deviation 7.1	53.5 scores on a scale Standard Deviation 7.1	50.8 scores on a scale Standard Deviation 10.5
Short Form-12 (SF-12) Physical Composite Scale (PCS) 6 Weeks	29.9 scores on a scale Standard Deviation 8.5	29.3 scores on a scale Standard Deviation 10.2	29.7 scores on a scale Standard Deviation 9.6	29.4 scores on a scale Standard Deviation 9.2
Short Form-12 (SF-12) Physical Composite Scale (PCS) 3 Months	36.2 scores on a scale Standard Deviation 11.2	36.7 scores on a scale Standard Deviation 10.7	37.2 scores on a scale Standard Deviation 12.0	35.7 scores on a scale Standard Deviation 9.5
Short Form-12 (SF-12) Physical Composite Scale (PCS) 6 Months	36.9 scores on a scale Standard Deviation 11.5	43.4 scores on a scale Standard Deviation 13.0	41.4 scores on a scale Standard Deviation 12.9	38.8 scores on a scale Standard Deviation 12.4
Short Form-12 (SF-12) Physical Composite Scale (PCS) 9 Months	38.3 scores on a scale Standard Deviation 12.8	45.0 scores on a scale Standard Deviation 13.2	41.8 scores on a scale Standard Deviation 14.0	42.4 scores on a scale Standard Deviation 12.5
Short Form-12 (SF-12) Physical Composite Scale (PCS) 12 Months	42.2 scores on a scale Standard Deviation 12.4	45.0 scores on a scale Standard Deviation 11.6	44.5 scores on a scale Standard Deviation 10.9	42.6 scores on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sliding Hip Screw n=43 Participants Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.	Cancellous Screws n=43 Participants Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.	Vitamin D Supplementation n=45 Participants Participants allocated to the vitamin D Group 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.	Vitamin D Placebo n=41 Participants Participants in the placebo group received 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.
Short Form-12 (SF-12) Mental Health Composite Scale (MCS) 3 Months	50.5 scores on a scale Standard Deviation 13.2	54.3 scores on a scale Standard Deviation 10.1	54.4 scores on a scale Standard Deviation 10.3	50.1 scores on a scale Standard Deviation 13.2
Short Form-12 (SF-12) Mental Health Composite Scale (MCS) Pre-fracture	55.6 scores on a scale Standard Deviation 8.1	53.1 scores on a scale Standard Deviation 8.3	54.3 scores on a scale Standard Deviation 7.6	54.2 scores on a scale Standard Deviation 9.0
Short Form-12 (SF-12) Mental Health Composite Scale (MCS) 6 Weeks	52.0 scores on a scale Standard Deviation 11.5	53.9 scores on a scale Standard Deviation 9.9	53.0 scores on a scale Standard Deviation 9.8	52.9 scores on a scale Standard Deviation 11.8
Short Form-12 (SF-12) Mental Health Composite Scale (MCS) 6 Months	55.0 scores on a scale Standard Deviation 9.9	54.2 scores on a scale Standard Deviation 8.6	52.9 scores on a scale Standard Deviation 8.2	57.0 scores on a scale Standard Deviation 10.2
Short Form-12 (SF-12) Mental Health Composite Scale (MCS) 9 Months	54.0 scores on a scale Standard Deviation 9.7	54.0 scores on a scale Standard Deviation 9.9	53.8 scores on a scale Standard Deviation 10.0	54.3 scores on a scale Standard Deviation 9.5
Short Form-12 (SF-12) Mental Health Composite Scale (MCS) 12 Months	52.9 scores on a scale Standard Deviation 9.8	53.3 scores on a scale Standard Deviation 9.2	52.4 scores on a scale Standard Deviation 9.3	53.9 scores on a scale Standard Deviation 9.6

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sliding Hip Screw n=43 Participants Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.	Cancellous Screws n=43 Participants Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.	Vitamin D Supplementation n=45 Participants Participants allocated to the vitamin D Group 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.	Vitamin D Placebo n=41 Participants Participants in the placebo group received 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.
Hip Outcome Score (HOS) Activities of Daily Living Scale Pre-fracture	89.2 scores on a scale Standard Deviation 20.4	95.4 scores on a scale Standard Deviation 14.8	93.1 scores on a scale Standard Deviation 18.3	91.5 scores on a scale Standard Deviation 17.7
Hip Outcome Score (HOS) Activities of Daily Living Scale 6 Weeks	39.1 scores on a scale Standard Deviation 19.5	36.1 scores on a scale Standard Deviation 23.1	38.1 scores on a scale Standard Deviation 23.1	37.1 scores on a scale Standard Deviation 19.0
Hip Outcome Score (HOS) Activities of Daily Living Scale 3 Months	56.8 scores on a scale Standard Deviation 24.1	59.3 scores on a scale Standard Deviation 25.5	56.7 scores on a scale Standard Deviation 25.4	59.8 scores on a scale Standard Deviation 23.7
Hip Outcome Score (HOS) Activities of Daily Living Scale 6 Months	64.5 scores on a scale Standard Deviation 24.4	74.4 scores on a scale Standard Deviation 23.1	69.7 scores on a scale Standard Deviation 23.8	69.6 scores on a scale Standard Deviation 25.0
Hip Outcome Score (HOS) Activities of Daily Living Scale 9 Months	69.0 scores on a scale Standard Deviation 21.1	79.6 scores on a scale Standard Deviation 22.4	75.1 scores on a scale Standard Deviation 23.2	74.7 scores on a scale Standard Deviation 21.4
Hip Outcome Score (HOS) Activities of Daily Living Scale 12 Months	73.0 scores on a scale Standard Deviation 22.7	79.4 scores on a scale Standard Deviation 22.7	76.6 scores on a scale Standard Deviation 21.5	76.2 scores on a scale Standard Deviation 23.5

SECONDARY outcome

Timeframe: Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery

Outcome measures

Outcome measures
Measure	Sliding Hip Screw n=43 Participants Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.	Cancellous Screws n=43 Participants Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.	Vitamin D Supplementation n=45 Participants Participants allocated to the vitamin D Group 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.	Vitamin D Placebo n=41 Participants Participants in the placebo group received 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.
Hip Outcome Score (HOS) Sports Scale Pre-fracture	78.5 scores on a scale Standard Deviation 33.5	86.9 scores on a scale Standard Deviation 25.9	88.6 scores on a scale Standard Deviation 25.5	76.4 scores on a scale Standard Deviation 33.3
Hip Outcome Score (HOS) Sports Scale 6 Weeks	9.3 scores on a scale Standard Deviation 14.9	8.0 scores on a scale Standard Deviation 13.4	8.0 scores on a scale Standard Deviation 13.7	9.4 scores on a scale Standard Deviation 14.7
Hip Outcome Score (HOS) Sports Scale 3 Months	20.8 scores on a scale Standard Deviation 22.9	21.4 scores on a scale Standard Deviation 25.1	20.1 scores on a scale Standard Deviation 23.8	22.2 scores on a scale Standard Deviation 23.9
Hip Outcome Score (HOS) Sports Scale 6 Months	33.0 scores on a scale Standard Deviation 31.0	45.1 scores on a scale Standard Deviation 28.7	38.1 scores on a scale Standard Deviation 30.7	41.0 scores on a scale Standard Deviation 29.5
Hip Outcome Score (HOS) Sports Scale 9 Months	42.8 scores on a scale Standard Deviation 33.9	54.8 scores on a scale Standard Deviation 28.7	52.4 scores on a scale Standard Deviation 33.0	45.6 scores on a scale Standard Deviation 29.2
Hip Outcome Score (HOS) Sports Scale 12 Months	47.5 scores on a scale Standard Deviation 31.0	57.3 scores on a scale Standard Deviation 31.4	52.4 scores on a scale Standard Deviation 33.4	53.1 scores on a scale Standard Deviation 29.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sliding Hip Screw n=43 Participants Participants allocated to the Sliding Hip Screw group received a single larger diameter partially threaded screw affixed to the proximal femur with a side plate.	Cancellous Screws n=43 Participants Participants allocated to the Cancellous Screws group received multiple cancellous screws with a minimum diameter of 6.5 mm.	Vitamin D Supplementation n=45 Participants Participants allocated to the vitamin D Group 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.	Vitamin D Placebo n=41 Participants Participants in the placebo group received 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.
Radiographic Fracture Healing	224.0 days Standard Deviation 131.5	236.7 days Standard Deviation 136.7	210.4 days Standard Deviation 121.0	252.3 days Standard Deviation 144.2

Adverse Events

Sliding Hip Screw + Vitamin D Supplementation

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Cancellous Screws + Vitamin D Supplementation

Serious events: 6 serious events

Other events: 3 other events

Deaths: 0 deaths

Sliding Hip Screw + Vitamin D Placebo

Serious events: 9 serious events

Other events: 3 other events

Deaths: 0 deaths

Cancellous Screws + Vitamin D Placebo

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sliding Hip Screw + Vitamin D Supplementation n=22 participants at risk 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.	Cancellous Screws + Vitamin D Supplementation n=23 participants at risk 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.	Sliding Hip Screw + Vitamin D Placebo n=21 participants at risk 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.	Cancellous Screws + Vitamin D Placebo n=20 participants at risk 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.
Cardiac disorders Aortic valve replacement due to intravalvular prosthetic regurgitation	0.00% 0/22 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/23 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/21 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	5.0% 1/20 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Painful Hardware or Hardware Failure/Breakage	4.5% 1/22 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	4.3% 1/23 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	19.0% 4/21 • Number of events 5 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	5.0% 1/20 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Nonunion	9.1% 2/22 • Number of events 2 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	13.0% 3/23 • Number of events 3 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	9.5% 2/21 • Number of events 2 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	10.0% 2/20 • Number of events 2 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Osteonecrosis, symptomatic	4.5% 1/22 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	8.7% 2/23 • Number of events 2 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	4.8% 1/21 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	5.0% 1/20 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Post-traumatic femoral acetabular impingement & hip range of motion restrictions	0.00% 0/22 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/23 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	9.5% 2/21 • Number of events 2 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/20 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Infection (deep)	4.5% 1/22 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/23 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/21 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/20 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event

Other adverse events

Other adverse events
Measure	Sliding Hip Screw + Vitamin D Supplementation n=22 participants at risk 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.	Cancellous Screws + Vitamin D Supplementation n=23 participants at risk 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.	Sliding Hip Screw + Vitamin D Placebo n=21 participants at risk 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.	Cancellous Screws + Vitamin D Placebo n=20 participants at risk 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.
Musculoskeletal and connective tissue disorders Delayed Union	0.00% 0/22 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	4.3% 1/23 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/21 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	5.0% 1/20 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Osteonecrosis, asymptomatic	4.5% 1/22 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	4.3% 1/23 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/21 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	5.0% 1/20 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Accident/Fall	0.00% 0/22 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/23 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	4.8% 1/21 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	5.0% 1/20 • Number of events 2 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Cardiac disorders Hypertension	0.00% 0/22 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	4.3% 1/23 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/21 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/20 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Skin and subcutaneous tissue disorders Rash/Skin Irritation	0.00% 0/22 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/23 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	9.5% 2/21 • Number of events 2 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/20 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event
Musculoskeletal and connective tissue disorders Meniscal tear	4.5% 1/22 • Number of events 1 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/23 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/21 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event	0.00% 0/20 • 12 months An AE is any symptom, sign, illness, or experience that develops or worsens in severity during the course of this study. AEs are classified as serious or non-serious. A SAE is any AE that is any of the following: * Fatal * Life threatening * Requires or prolongs hospital stay * Results in persistent or significant disability or incapacity * A congenital anomaly or birth defect * An important medical event

Additional Information

Dr. Mohit Bhandari

McMaster University

Phone: 9055274322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place