Trial Outcomes & Findings for Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study) (NCT NCT00761813)
NCT ID: NCT00761813
Last Updated: 2018-01-05
Results Overview
Additional Surgery on the affected hip
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1108 participants
Primary outcome timeframe
Measured 2 years after original surgery
Results posted on
2018-01-05
Participant Flow
Subjects were consented and then randomized. Some subjects were enrolled but dropped prior to randomization. Or withdrew after being randomized so no data was collected
Participant milestones
| Measure |
Single Sliding Hip Screw
Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Multiple Cancellous Screws
ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
|---|---|---|
|
Overall Study
STARTED
|
557
|
551
|
|
Overall Study
COMPLETED
|
542
|
537
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using Alternative Implants for the Surgical Treatment of Hip Fractures (The FAITH Study)
Baseline characteristics by cohort
| Measure |
Single Sliding Hip Screw
n=542 Participants
Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Multiple Cancellous Screws
n=537 Participants
ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Total
n=1079 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
72.0 years
STANDARD_DEVIATION 12.3 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
330 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
657 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
422 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
211 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
420 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
111 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
121 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
India
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured 2 years after original surgeryAdditional Surgery on the affected hip
Outcome measures
| Measure |
Single Sliding Hip Screw
n=542 Participants
Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Multiple Cancellous Screws
n=537 Participants
ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
|---|---|---|
|
Revision Surgery
|
107 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: Measured 2 years after original surgeryPopulation: secondary outcomes not given or completed to all subjects
The SF-12 PCS is the short form - 12 Health Survey Physical component summary - 0 is bad and 100 is good The WOMAC is Western Ontario and McMaster Universities Osteoarthritis Index 0 is good and 100 is bad The EQ-5D is EuroQol5D 1 is good and 5 is bad
Outcome measures
| Measure |
Single Sliding Hip Screw
n=235 Participants
Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Multiple Cancellous Screws
n=224 Participants
ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
|---|---|---|
|
Quality of Life
SF-12 PCS
|
41.6 units on a scale
Standard Deviation 10.9
|
41.4 units on a scale
Standard Deviation 11.8
|
|
Quality of Life
WOMAC
|
40.97 units on a scale
Standard Deviation 16.33
|
39.75 units on a scale
Standard Deviation 17.09
|
|
Quality of Life
EQ-5D
|
0.79 units on a scale
Standard Deviation 0.19
|
0.80 units on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Measured 2 years after original surgeryOutcome measures
| Measure |
Single Sliding Hip Screw
n=542 Participants
Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Multiple Cancellous Screws
n=537 Participants
ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
|---|---|---|
|
Complications, Including Avascular Necrosis, Nonunion, and Infection
AVN
|
50 participants
|
28 participants
|
|
Complications, Including Avascular Necrosis, Nonunion, and Infection
Nonunion
|
33 participants
|
33 participants
|
|
Complications, Including Avascular Necrosis, Nonunion, and Infection
Infection
|
10 participants
|
9 participants
|
Adverse Events
Single Sliding Hip Screw
Serious events: 115 serious events
Other events: 55 other events
Deaths: 2 deaths
Multiple Cancellous Screws
Serious events: 104 serious events
Other events: 45 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Single Sliding Hip Screw
n=542 participants at risk
Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Multiple Cancellous Screws
n=537 participants at risk
ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
|---|---|---|
|
Blood and lymphatic system disorders
Abnormal Blood Complications
|
2.2%
12/542 • Number of events 13
|
1.3%
7/537 • Number of events 8
|
|
General disorders
Altered mental Status
|
0.74%
4/542 • Number of events 5
|
1.1%
6/537 • Number of events 10
|
|
General disorders
Cancer
|
0.92%
5/542 • Number of events 5
|
0.56%
3/537 • Number of events 3
|
|
Cardiac disorders
Cardiovascular
|
3.5%
19/542 • Number of events 31
|
3.4%
18/537 • Number of events 22
|
|
General disorders
Death
|
0.37%
2/542 • Number of events 2
|
1.5%
8/537 • Number of events 8
|
|
Gastrointestinal disorders
Digestive Events
|
1.5%
8/542 • Number of events 8
|
1.5%
8/537 • Number of events 8
|
|
General disorders
Fall
|
0.37%
2/542 • Number of events 2
|
0.37%
2/537 • Number of events 2
|
|
General disorders
Hernia
|
0.00%
0/542
|
0.19%
1/537 • Number of events 1
|
|
Infections and infestations
Infection/Sepsis
|
1.1%
6/542 • Number of events 6
|
0.93%
5/537 • Number of events 8
|
|
General disorders
Other
|
3.7%
20/542 • Number of events 25
|
2.2%
12/537 • Number of events 14
|
|
Musculoskeletal and connective tissue disorders
Other fractures
|
0.92%
5/542 • Number of events 10
|
1.7%
9/537 • Number of events 12
|
|
General disorders
Pain
|
0.74%
4/542 • Number of events 6
|
0.56%
3/537 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
3.0%
16/542 • Number of events 40
|
2.0%
11/537 • Number of events 20
|
|
Renal and urinary disorders
Renal Disease/Events
|
0.92%
5/542 • Number of events 6
|
0.93%
5/537 • Number of events 5
|
|
Renal and urinary disorders
UTI
|
1.3%
7/542 • Number of events 8
|
1.1%
6/537 • Number of events 6
|
Other adverse events
| Measure |
Single Sliding Hip Screw
n=542 participants at risk
Open reduction internal fixation (ORIF) with single sliding hip screw: The ORIF will be performed using a single large diameter partially threaded screw that is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixations. Surgeons will use any commercially available sliding hip screw implant and will insert implants as per the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
Multiple Cancellous Screws
n=537 participants at risk
ORIF with multiple cancellous screws: ORIF will be performed using multiple small diameter threaded screws (with a minimum of two screws and a minimum diameter of 6.5 mm). Surgeons will use any threaded screw or hook pin and will follow the manufacturers' technical guides. Other surgical factors will be based on surgeon preference and noted.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory
|
0.74%
4/542 • Number of events 4
|
0.19%
1/537 • Number of events 1
|
|
Cardiac disorders
Avascular Necrosis
|
8.1%
44/542 • Number of events 65
|
5.6%
30/537 • Number of events 39
|
|
Infections and infestations
Bacterial Infection
|
0.18%
1/542 • Number of events 1
|
0.00%
0/537
|
|
General disorders
Cancer
|
1.3%
7/542 • Number of events 7
|
1.9%
10/537 • Number of events 10
|
|
Cardiac disorders
Cardiovascular Event
|
0.92%
5/542 • Number of events 5
|
2.4%
13/537 • Number of events 14
|
|
General disorders
Deep Brain Thrombosis
|
0.74%
4/542 • Number of events 4
|
0.74%
4/537 • Number of events 4
|
|
Infections and infestations
Infection
|
0.37%
2/542 • Number of events 2
|
0.00%
0/537
|
|
General disorders
Metal Allergy
|
0.18%
1/542 • Number of events 1
|
0.00%
0/537
|
|
General disorders
Other
|
0.18%
1/542 • Number of events 1
|
0.00%
0/537
|
|
Respiratory, thoracic and mediastinal disorders
Pnuemonia
|
0.18%
1/542 • Number of events 1
|
0.00%
0/537
|
|
General disorders
Prolonged Hospitalization
|
0.00%
0/542
|
0.19%
1/537 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.55%
3/542 • Number of events 3
|
0.37%
2/537 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
0.37%
2/542 • Number of events 2
|
0.37%
2/537 • Number of events 2
|
|
General disorders
Sepsis
|
0.00%
0/542
|
0.19%
1/537 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place