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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01908751
Registration number
NCT01908751
Ethics application status
Date submitted
18/07/2013
Date registered
26/07/2013
Date last updated
30/11/2020
Titles & IDs
Public title
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
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Scientific title
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): A Multi-Centre 2x2 Factorial Randomized Trial Comparing Sliding Hip Screws Versus Cancellous Screws AND Vitamin D Versus Placebo on Patient Important Outcomes and Quality of Life in the Treatment of Young Adult (18-60) Femoral Neck Fractures
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Secondary ID [1]
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FAITH-2
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Universal Trial Number (UTN)
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Trial acronym
FAITH-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Femoral Neck Fractures
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Sliding Hip Screw
Treatment: Surgery - Cancellous Screws
Treatment: Drugs - Vitamin D
Treatment: Drugs - Vitamin D Placebo
Experimental: Sliding Hip Screw and Vitamin D supplementation - Participants allocated to the vitamin D Group will be given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group will receive a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants will be instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
Experimental: Sliding Hip Screw and Vitamin D placebo - 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. The placebo supplement is also manufactured by the Ddrops Company.
Experimental: Cancellous Screws and Vitamin D supplementation - Participants allocated to the vitamin D Group will be given a six-month supply of vitamin D3 supplementation. Participants in the vitamin D Group will receive a bottle of 2,000 International Units (IU) vitamin D3 drops (Ddrops®, Ddrops Company). Participants will be instructed to take two drops daily for six months, for a total daily dose of 4,000 IU.
Experimental: Cancellous Screws and Vitamin D placebo - 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. The placebo supplement is also manufactured by the Ddrops Company.
Treatment: Surgery: Sliding Hip Screw
Treatment: Surgery: Cancellous Screws
Treatment: Drugs: Vitamin D
Treatment: Drugs: Vitamin D Placebo
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Patient Important Outcomes
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Assessment method [1]
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A participant met the primary clinical endpoint if they experienced one or more of the four outcomes:
Re-operation: any unplanned surgery related to the treatment of the femoral neck fracture;
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);
Severe femoral neck malunion: fracture healing with femoral neck shortening of >10 mm in any plane on follow-up x-rays; or
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.
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Timepoint [1]
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12 months post-surgery
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Secondary outcome [1]
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Number of Participants With Non-Operatively-Treated Fracture Healing Complications
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Assessment method [1]
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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.
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Timepoint [1]
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12 months post-surgery
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Secondary outcome [2]
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Short Form-12 (SF-12) Physical Composite Scale (PCS)
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Assessment method [2]
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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.
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Timepoint [2]
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Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
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Secondary outcome [3]
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Short Form-12 (SF-12) Mental Health Composite Scale (MCS)
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Assessment method [3]
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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.
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Timepoint [3]
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Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
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Secondary outcome [4]
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Hip Outcome Score (HOS) Activities of Daily Living Scale
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Assessment method [4]
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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).
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Timepoint [4]
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Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
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Secondary outcome [5]
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Hip Outcome Score (HOS) Sports Scale
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Assessment method [5]
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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).
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Timepoint [5]
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Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
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Secondary outcome [6]
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Radiographic Fracture Healing
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Assessment method [6]
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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.
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Timepoint [6]
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up to 12 months post-surgery
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
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Maximum age
60
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/03/2019
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Sample size
Target
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Accrual to date
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Final
91
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Maryland
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United States of America
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Michigan
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Minnesota
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United States of America
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Pennsylvania
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United States of America
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State/province [9]
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Virginia
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United States of America
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State/province [10]
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West Virginia
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Canada
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State/province [11]
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British Columbia
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Canada
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Manitoba
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Canada
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State/province [13]
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Newfoundland and Labrador
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Canada
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State/province [14]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Canadian Institutes of Health Research (CIHR)
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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McMaster Surgical Associates
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Hamilton Health Sciences Corporation
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Address [3]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01908751
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Trial related presentations / publications
Baitner AC, Maurer SG, Hickey DG, Jazrawi LM, Kummer FJ, Jamal J, Goldman S, Koval KJ. Vertical shear fractures of the femoral neck. A biomechanical study. Clin Orthop Relat Res. 1999 Oct;(367):300-5.
Bee CR, Sheerin DV, Wuest TK, Fitzpatrick DC. Serum vitamin D levels in orthopaedic trauma patients living in the northwestern United States. J Orthop Trauma. 2013 May;27(5):e103-6. doi: 10.1097/BOT.0b013e31825cf8fb.
Bhandari M, Devereaux PJ, Swiontkowski MF, Tornetta P 3rd, Obremskey W, Koval KJ, Nork S, Sprague S, Schemitsch EH, Guyatt GH. Internal fixation compared with arthroplasty for displaced fractures of the femoral neck. A meta-analysis. J Bone Joint Surg Am. 2003 Sep;85(9):1673-81. doi: 10.2106/00004623-200309000-00004.
Bhandari M, Tornetta P 3rd, Hanson B, Swiontkowski MF. Optimal internal fixation for femoral neck fractures: multiple screws or sliding hip screws? J Orthop Trauma. 2009 Jul;23(6):403-7. doi: 10.1097/BOT.0b013e318176191f.
Chen Z, Wang G, Lin J, Yang T, Fang Y, Liu L, Zhang H. [Efficacy comparison between dynamic hip screw combined with anti-rotation screw and cannulated screw in treating femoral neck fractures]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2011 Jan;25(1):26-9. Chinese.
Damany DS, Parker MJ, Chojnowski A. Complications after intracapsular hip fractures in young adults. A meta-analysis of 18 published studies involving 564 fractures. Injury. 2005 Jan;36(1):131-41. doi: 10.1016/j.injury.2004.05.023.
Doetsch AM, Faber J, Lynnerup N, Watjen I, Bliddal H, Danneskiold-Samsoe B. The effect of calcium and vitamin D3 supplementation on the healing of the proximal humerus fracture: a randomized placebo-controlled study. Calcif Tissue Int. 2004 Sep;75(3):183-8. doi: 10.1007/s00223-004-0167-0.
Hamilton B. Vitamin D and human skeletal muscle. Scand J Med Sci Sports. 2010 Apr;20(2):182-90. doi: 10.1111/j.1600-0838.2009.01016.x. Epub 2009 Oct 5.
Johansson A, Stromqvist B, Bauer G, Hansson LI, Pettersson H. Improved operations for femoral neck fracture. A radiographic evaluation. Acta Orthop Scand. 1986 Dec;57(6):505-9. doi: 10.3109/17453678609014779.
Langlois K, Greene-Finestone L, Little J, Hidiroglou N, Whiting S. Vitamin D status of Canadians as measured in the 2007 to 2009 Canadian Health Measures Survey. Health Rep. 2010 Mar;21(1):47-55.
Lappe J, Cullen D, Haynatzki G, Recker R, Ahlf R, Thompson K. Calcium and vitamin d supplementation decreases incidence of stress fractures in female navy recruits. J Bone Miner Res. 2008 May;23(5):741-9. doi: 10.1359/jbmr.080102.
Lidor C, Dekel S, Hallel T, Edelstein S. Levels of active metabolites of vitamin D3 in the callus of fracture repair in chicks. J Bone Joint Surg Br. 1987 Jan;69(1):132-6. doi: 10.1302/0301-620X.69B1.3029136.
Linde F, Andersen E, Hvass I, Madsen F, Pallesen R. Avascular femoral head necrosis following fracture fixation. Injury. 1986 May;17(3):159-63. doi: 10.1016/0020-1383(86)90322-0.
Lindequist S. Cortical screw support in femoral neck fractures. A radiographic analysis of 87 fractures with a new mensuration technique. Acta Orthop Scand. 1993 Jun;64(3):289-93. doi: 10.3109/17453679308993627.
Malchau H, Herberts P, Eisler T, Garellick G, Soderman P. The Swedish Total Hip Replacement Register. J Bone Joint Surg Am. 2002;84-A Suppl 2:2-20. doi: 10.2106/00004623-200200002-00002. No abstract available. Erratum In: J Bone Joint Surg Am. 2004 Feb;86-A(2):363.
Omeroglu H, Ates Y, Akkus O, Korkusuz F, Bicimoglu A, Akkas N. Biomechanical analysis of the effects of single high-dose vitamin D3 on fracture healing in a healthy rabbit model. Arch Orthop Trauma Surg. 1997;116(5):271-4. doi: 10.1007/BF00390051.
Omeroglu S, Erdogan D, Omeroglu H. Effects of single high-dose vitamin D3 on fracture healing. An ultrastructural study in healthy guinea pigs. Arch Orthop Trauma Surg. 1997;116(1-2):37-40.
Patil S, Garbuz DS, Greidanus NV, Masri BA, Duncan CP. Quality of life outcomes in revision vs primary total hip arthroplasty: a prospective cohort study. J Arthroplasty. 2008 Jun;23(4):550-3. doi: 10.1016/j.arth.2007.04.035. Epub 2007 Oct 23.
Sakalli H, Arslan D, Yucel AE. The effect of oral and parenteral vitamin D supplementation in the elderly: a prospective, double-blinded, randomized, placebo-controlled study. Rheumatol Int. 2012 Aug;32(8):2279-83. doi: 10.1007/s00296-011-1943-6. Epub 2011 May 10.
Swiontkowski MF, Harrington RM, Keller TS, Van Patten PK. Torsion and bending analysis of internal fixation techniques for femoral neck fractures: the role of implant design and bone density. J Orthop Res. 1987;5(3):433-44. doi: 10.1002/jor.1100050316.
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Public notes
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Contacts
Principal investigator
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Gerard Slobogean, MD
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Address
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University of Maryland, College Park
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01908751
Download to PDF