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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
FAITH-2
Universal Trial Number (UTN)
Trial acronym
FAITH-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoral Neck Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Patient Important Outcomes
Timepoint [1] 0 0
12 months post-surgery
Secondary outcome [1] 0 0
Number of Participants With Non-Operatively-Treated Fracture Healing Complications
Timepoint [1] 0 0
12 months post-surgery
Secondary outcome [2] 0 0
Short Form-12 (SF-12) Physical Composite Scale (PCS)
Timepoint [2] 0 0
Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Secondary outcome [3] 0 0
Short Form-12 (SF-12) Mental Health Composite Scale (MCS)
Timepoint [3] 0 0
Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Secondary outcome [4] 0 0
Hip Outcome Score (HOS) Activities of Daily Living Scale
Timepoint [4] 0 0
Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Secondary outcome [5] 0 0
Hip Outcome Score (HOS) Sports Scale
Timepoint [5] 0 0
Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery
Secondary outcome [6] 0 0
Radiographic Fracture Healing
Timepoint [6] 0 0
up to 12 months post-surgery

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/03/2019
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
United States of America
State/province [10] 0 0
West Virginia
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
Newfoundland and Labrador
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
McMaster Surgical Associates
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Hamilton Health Sciences Corporation
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerard Slobogean, MD
Address 0 0
University of Maryland, College Park
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01908751