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Femoral Neck FracturesPhase 3FAITH-2NCT01908751

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

A Phase 3 study testing Sliding Hip Screw, Cancellous Screws and Vitamin D in people with Femoral Neck Fractures, run by McMaster University at 20 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Femoral Neck Fractures
What is being tested?
Sliding Hip Screw, Cancellous Screws and Vitamin D
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
20 sitesin 3 countries
Study dates
Sep 2014to 18 Mar 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult men or women ages 18 to 60 years.
  • Fracture of the femoral neck.
  • Fracture amenable to both surgical treatments (SHS and cancellous screws).
  • Operative treatment within 7 days of injury.
  • Provision of informed consent by patient or substitute decision maker.

Who cannot join

  • Patients with previously diagnosed osteoporosis.
  • Fracture-dislocation of the femoral neck and hip joint.
  • Planned antegrade nailing of an ipsilateral femoral shaft fracture (if present).
  • Current infection around the hip (i.e. soft tissue or bone).
  • Stress fracture of the femoral neck.
  • Pathologic fractures secondary to neoplasm or other bone lesion.
Show all 15Show fewer
  • Patients with known or likely undiagnosed disorders of bone metabolism such as Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfect, etc.
  • Patients with hyperhomocysteinemia.
  • Patient has an allergy to vitamin D or another contraindication to being prescribed vitamin D.
  • 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.
  • 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.
  • Pregnancy.
  • Patient is incarcerated.
  • Patient is not expected to survive injuries.
  • The attending surgeon believes the patient should be excluded because they are involved in a conflicting clinical trial.

Trial locations and contacts

20 sites in 3 countries.

20 sites in 3 countries

United States10 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201

  • Inova Health Care Services

    Falls Church, Virginia, 22042

  • University of Florida

    Gainesville, Florida, 32611

  • Indiana University (IU Health Methodist Hospital)

    Indianapolis, Indiana, 46202

  • Hennepin Healthcare System

    Minneapolis, Minnesota, 55415

  • West Virginia University

    Morgantown, West Virginia, 26506

  • The Center for Orthopedic Research and Education (CORE) Institute

    Phoenix, Arizona, 85023

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • University of California, San Francisco

    San Francisco, California, 94110

Other trials in United States

Canada9 sites

  • Hamilton Health Sciences

    Hamilton, Ontario

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • Royal Columbian Hospital

    New Westminster, British Columbia

  • Ottawa Hospital Research Institute

    Ottawa, Ontario

  • Memorial University

    St. John's, Newfoundland and Labrador, A1B 3X9

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario

  • University of British Columbia & Vancouver Costal Health Authority

    Vancouver, British Columbia

  • Health Sciences Centre Winnipeg

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Australia1 site

  • Alfred Health

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official 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

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.

Read the 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.

Being tested
Sliding Hip Screw, Cancellous Screws, Vitamin D, Vitamin D Placebo
Medical subject headings
Femoral Neck Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sliding Hip ScrewProcedure or surgery

  • Cancellous ScrewsProcedure or surgery

  • Vitamin DDrug

  • Vitamin D PlaceboDrug

Study groups in NCT01908751
Study groupRoleWhat they receive
Sliding Hip Screw and Vitamin D supplementationExperimentalParticipants 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.
Receives: Procedure: Sliding Hip Screw; Drug: Vitamin D
Sliding Hip Screw and Vitamin D placeboExperimentalParticipants 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.
Receives: Procedure: Sliding Hip Screw; Drug: Vitamin D Placebo
Cancellous Screws and Vitamin D supplementationExperimentalParticipants 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.
Receives: Procedure: Cancellous Screws; Drug: Vitamin D
Cancellous Screws and Vitamin D placeboExperimentalParticipants 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.
Receives: Procedure: Cancellous Screws; Drug: Vitamin D Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months post-surgery

Secondary outcomes (6)

  1. 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.

    Measured: 12 months post-surgery

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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).

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

  6. 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.

    Measured: up to 12 months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2013 (estimated)
  2. Study startSep 2014
  3. Primary completion18 Mar 2019
  4. Study completion18 Mar 2019

Why it stopped: Continuing beyond the pilot phase of the trial was deemed unfeasible

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01908751
Sponsor's protocol ID
FAITH-2
Acronym
FAITH-2
Status last verified
Nov 2020
First submitted
18 Jul 2013
Last updated
30 Nov 2020
Data monitoring committee
Yes

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.

    PubMed 10546628

  • 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.

    PubMed 22576645

  • 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.

    PubMed 12954824

  • 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.

    PubMed 19550225

  • 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.

    PubMed 21351604

  • 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.

    PubMed 15589931

  • 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.

    PubMed 15386160

  • 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.

    PubMed 19807897

  • 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.

    PubMed 3577716

  • 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.

    PubMed 20426226

  • 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.

    PubMed 18433305

  • 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.

    PubMed 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.

    PubMed 3818052

  • 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.

    PubMed 8322583

  • 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.

    PubMed 12479335

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sliding Hip Screw, Cancellous Screws and Vitamin D in people with Femoral Neck Fractures, run by McMaster University at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Patient Important Outcomes (time frame: 12 months post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01908751, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.

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