Trial · NCT01908751
Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
NCT01908751, Phase 3, Terminated, McMaster University; results first posted 2020-11-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2). Trials, record NCT01908751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01908751
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)
- NCT number
- NCT01908751
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- McMaster University
- Conditions
- Femoral Neck Fractures
- Interventions
- Sliding Hip Screw, Cancellous Screws, Vitamin D, Vitamin D Placebo
- First posted
- 2013-07-26
- Last updated
- 2020-11-30
- Results first posted
- 2020-11-30
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Patient Important Outcomes | 12 months post-surgery | A participant met the primary clinical endpoint if they experienced one or more of the four outcomes: 1. Re-operation: any unplanned surgery related to the treatment of the femoral neck fracture; 2. Femoral head osteonecrosis: any evidence of osteonecrosis on any follow-up medical imaging study (i.e., radiographs, magnetic resonance imaging (MRI), or other advanced imaging study); 3. Severe femoral neck malunion: fracture healing with femoral neck shortening of \>10 mm in any plane on follow-up x-rays; or 4. Nonunion: failure of the fracture to progress towards healing defined as a Radiographic Union Score for Hip (RUSH) score below a pre-determined threshold specific for nonunion at 6 months or greater post-injury. |
| Secondary | Number of Participants With Non-Operatively-Treated Fracture Healing Complications | 12 months post-surgery | Fracture healing complications treated non-operatively are presented in this table and included wound healing problems, infection (superficial and deep), hardware failure, hardware breakage, painful hardware, and peri-prosthetic fracture. |
| Secondary | Short Form-12 (SF-12) Physical Composite Scale (PCS) | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The SF-12 is a 12-item questionnaire that measures self-reported quality of life through an 8-domain profile of functional health and well-being, physical and mental health summary measures and a preference-based health utility index. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
| Secondary | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The SF-12 is a 12-item questionnaire that measures self-reported quali... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome. Scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. |
| Secondary | Hip Outcome Score (HOS) Activities of Daily Living Scale | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function). |
| Secondary | Hip Outcome Score (HOS) Sports Scale | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | The HOS measures self-reported functional status through 28 items and two sub-scales that pertain to activities of daily living (ADLs) or higher level activities such as those necessary to participate in sports. Scores for each subscale range from 0 (least function) to 100 (most function). |
| Secondary | Radiographic Fracture Healing | up to 12 months post-surgery | The date of healing will be determined by the Central Adjudication Committee (CAC). They will consider a fracture as healed when there is obliteration of the fracture line by newly formed bone along the cortices and within the trabecular bone on anterior-posterior and lateral radiographs. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Patient Important Outcomes | 12 months post-surgery | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Non-Operatively-Treated Fracture Healing Complications | 12 months post-surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Short Form-12 (SF-12) Physical Composite Scale (PCS) | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | 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. | scores on a scale | MEAN |
| SECONDARY | Short Form-12 (SF-12) Mental Health Composite Scale (MCS) | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | 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. | scores on a scale | MEAN |
| SECONDARY | Hip Outcome Score (HOS) Activities of Daily Living Scale | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | 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. | scores on a scale | MEAN |
| SECONDARY | Hip Outcome Score (HOS) Sports Scale | Pre-fracture, 6 weeks, 3 months, 6 months, 9 months, 12 months post-surgery | 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. | scores on a scale | MEAN |
| SECONDARY | Radiographic Fracture Healing | up to 12 months post-surgery | 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. | days | MEAN |
Source ClinicalTrials.gov
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Patient Important Outcomes | Sliding Hip Screw | Primary Clinical Endpoint | 11 | Participants | |
| Number of Participants With Patient Important Outcomes | Cancellous Screws | Primary Clinical Endpoint | 13 | Participants | |
| Number of Participants With Patient Important Outcomes | Vitamin D Supplementation | Primary Clinical Endpoint | 11 | Participants | |
| Number of Participants With Patient Important Outcomes | Vitamin D Placebo | Primary Clinical Endpoint | 13 | Participants | |
| Number of Participants With Patient Important Outcomes | Sliding Hip Screw | Re-operation | 9 | Participants | |
| Number of Participants With Patient Important Outcomes | Cancellous Screws | Re-operation | 6 | Participants | |
| Number of Participants With Patient Important Outcomes | Vitamin D Supplementation | Re-operation | 7 | Participants | |
| Number of Participants With Patient Important Outcomes | Vitamin D Placebo | Re-operation | 8 | Participants | |
| Number of Participants With Patient Important Outcomes | Sliding Hip Screw | Femoral head osteonecrosis | 2 | Participants | |
| Number of Participants With Patient Important Outcomes | Cancellous Screws | Femoral head osteonecrosis | 7 | Participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sliding Hip Screw + Vitamin D Supplementation | 22 | |
| Overall Study | STARTED | Cancellous Screws + Vitamin D Supplementation | 23 | |
| Overall Study | STARTED | Sliding Hip Screw + Vitamin D Placebo | 21 | |
| Overall Study | STARTED | Cancellous Screws + Vitamin D Placebo | 20 | |
| Overall Study | COMPLETED | Sliding Hip Screw + Vitamin D Supplementation | 17 | |
| Overall Study | COMPLETED | Cancellous Screws + Vitamin D Supplementation | 18 | |
| Overall Study | COMPLETED | Sliding Hip Screw + Vitamin D Placebo | 16 | |
| Overall Study | COMPLETED | Cancellous Screws + Vitamin D Placebo | 16 | |
| Overall Study | NOT COMPLETED | Sliding Hip Screw + Vitamin D Supplementation | 5 | |
| Overall Study | NOT COMPLETED | Cancellous Screws + Vitamin D Supplementation | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Delayed Union | Musculoskeletal and connective tissue disorders | Sliding Hip Screw + Vitamin D Supplementation | 0 | 22 | 0 |
| other | Delayed Union | Musculoskeletal and connective tissue disorders | Cancellous Screws + Vitamin D Supplementation | 1 | 23 | 1 |
| other | Delayed Union | Musculoskeletal and connective tissue disorders | Sliding Hip Screw + Vitamin D Placebo | 0 | 21 | 0 |
| other | Delayed Union | Musculoskeletal and connective tissue disorders | Cancellous Screws + Vitamin D Placebo | 1 | 20 | 1 |
| other | Osteonecrosis, asymptomatic | Musculoskeletal and connective tissue disorders | Sliding Hip Screw + Vitamin D Supplementation | 1 | 22 | 1 |
| other | Osteonecrosis, asymptomatic | Musculoskeletal and connective tissue disorders | Cancellous Screws + Vitamin D Supplementation | 1 | 23 | 1 |
| other | Osteonecrosis, asymptomatic | Musculoskeletal and connective tissue disorders | Sliding Hip Screw + Vitamin D Placebo | 0 | 21 | 0 |
| other | Osteonecrosis, asymptomatic | Musculoskeletal and connective tissue disorders | Cancellous Screws + Vitamin D Placebo | 1 | 20 | 1 |
| other | Accident/Fall | Musculoskeletal and connective tissue disorders | Sliding Hip Screw + Vitamin D Supplementation | 0 | 22 | 0 |
| other | Accident/Fall | Musculoskeletal and connective tissue disorders | Cancellous Screws + Vitamin D Supplementation | 0 | 23 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sliding Hip Screw + Vitamin D Supplementation | 0 | 22 |
| Total, all-cause mortality | Cancellous Screws + Vitamin D Supplementation | 0 | 23 |
| Total, all-cause mortality | Sliding Hip Screw + Vitamin D Placebo | 0 | 21 |
| Total, all-cause mortality | Cancellous Screws + Vitamin D Placebo | 0 | 20 |
| Total, other adverse events | Sliding Hip Screw + Vitamin D Supplementation | 2 | 22 |
| Total, other adverse events | Cancellous Screws + Vitamin D Supplementation | 3 | 23 |
| Total, other adverse events | Sliding Hip Screw + Vitamin D Placebo | 3 | 21 |
| Total, other adverse events | Cancellous Screws + Vitamin D Placebo | 3 | 20 |
| Total, serious adverse events | Sliding Hip Screw + Vitamin D Supplementation | 5 | 22 |
| Total, serious adverse events | Cancellous Screws + Vitamin D Supplementation | 6 | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers21
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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