Trial Outcomes & Findings for A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures (NCT NCT00718302)
NCT ID: NCT00718302
Last Updated: 2017-03-29
Results Overview
Percentage of Participants with Nonpalpable Hardware
COMPLETED
NA
249 participants
3 months, 6 months, 12 months
2017-03-29
Participant Flow
249 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 233 subjects entered the flow.
Participant milestones
| Measure |
Antiglide Plate
Antiglide Plate: A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
Lateral Plate: A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
114
|
|
Overall Study
COMPLETED
|
119
|
114
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
Baseline characteristics by cohort
| Measure |
Antiglide Plate
n=119 Participants
A plate is placed behind the broken ankle and secured with screws.
|
Lateral Plate
n=114 Participants
A metal plate is placed to the side of the broken ankle and is secured with screws
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 months, 12 monthsPopulation: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP)
Percentage of Participants with Nonpalpable Hardware
Outcome measures
| Measure |
Antiglide Plate
n=88 Participants
A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
n=89 Participants
A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
Percentage of Nonpalpable Hardware
3 months
|
71 percentage of participants
|
55 percentage of participants
|
|
Percentage of Nonpalpable Hardware
6 months
|
64 percentage of participants
|
66 percentage of participants
|
|
Percentage of Nonpalpable Hardware
12 months
|
51 percentage of participants
|
44 percentage of participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsPopulation: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.
Percentage of Participants with Normal Peroneal Tendons
Outcome measures
| Measure |
Antiglide Plate
n=88 Participants
A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
n=89 Participants
A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
Percentage Normal Peroneal Tendons
3 months
|
88 percentage of participants
|
88 percentage of participants
|
|
Percentage Normal Peroneal Tendons
6 months
|
91 percentage of participants
|
92 percentage of participants
|
|
Percentage Normal Peroneal Tendons
12 months
|
88 percentage of participants
|
90 percentage of participants
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsPopulation: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.
American Orthopedic Foot and Ankle Society Score (AOFAS) score. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. A subject can score anywhere from 0-100, 100 being best.
Outcome measures
| Measure |
Antiglide Plate
n=88 Participants
A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
n=89 Participants
A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
3 months
|
81.6 units on a scale
Standard Deviation 12.8
|
82.8 units on a scale
Standard Deviation 11.69
|
|
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
6 months
|
87.24 units on a scale
Standard Deviation 10.74
|
87.43 units on a scale
Standard Deviation 12.06
|
|
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
12 months
|
90.11 units on a scale
Standard Deviation 9.52
|
89.44 units on a scale
Standard Deviation 11.08
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 monthsPopulation: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.
The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.
Outcome measures
| Measure |
Antiglide Plate
n=88 Participants
A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
n=89 Participants
A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
The Short Musculoskeletal Functional Assessment (SMFA) Score
3 months
|
25.1 units on a scale
Standard Deviation 16.41
|
27.2 units on a scale
Standard Deviation 19.36
|
|
The Short Musculoskeletal Functional Assessment (SMFA) Score
6 months
|
15.3 units on a scale
Standard Deviation 13.72
|
18.6 units on a scale
Standard Deviation 18.75
|
|
The Short Musculoskeletal Functional Assessment (SMFA) Score
12 months
|
11.6 units on a scale
Standard Deviation 14.15
|
15.6 units on a scale
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 12 monthsPopulation: Participants analyzed at 3 months - 88 (AP) / 89 (LP) Participants analyzed at 6 months - 68 (AP) / 67 (LP) Participants analyzed at 12 months - 53 (AP) / 51 (LP) Numbers differ due to incomplete data collection or subjects were lost to follow up.
The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.
Outcome measures
| Measure |
Antiglide Plate
n=88 Participants
A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
n=89 Participants
A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
SMFA - Bother Index
3 months
|
23.1 units on a scale
Standard Deviation 19.05
|
25.9 units on a scale
Standard Deviation 20.07
|
|
SMFA - Bother Index
6 months
|
14.1 units on a scale
Standard Deviation 17.48
|
19.1 units on a scale
Standard Deviation 20.09
|
|
SMFA - Bother Index
12 months
|
12.8 units on a scale
Standard Deviation 18.09
|
16.6 units on a scale
Standard Deviation 22.04
|
Adverse Events
Antiglide Plate
Lateral Plate
Serious adverse events
| Measure |
Antiglide Plate
n=119 participants at risk
A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
n=114 participants at risk
A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
Surgical and medical procedures
Non-Union
|
0.00%
0/119 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
0.88%
1/114 • Number of events 1 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Blood and lymphatic system disorders
SUBJECT EXPIRED DUE TO CANCER
|
0.84%
1/119 • Number of events 1 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
0.00%
0/114 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
Other adverse events
| Measure |
Antiglide Plate
n=119 participants at risk
A plate is placed behind the broken ankle and secured with screws
|
Lateral Plate
n=114 participants at risk
A metal plate is placed to the side of the broken ankle and is secured with screws
|
|---|---|---|
|
Surgical and medical procedures
PAINFUL IMPLANT-SCREW,PLATE
|
3.4%
4/119 • Number of events 4 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
1.8%
2/114 • Number of events 2 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Infections and infestations
Infection
|
5.9%
7/119 • Number of events 7 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
1.8%
2/114 • Number of events 2 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Skin and subcutaneous tissue disorders
Necrosis
|
0.00%
0/119 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
1.8%
2/114 • Number of events 2 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Vascular disorders
DVT
|
1.7%
2/119 • Number of events 2 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
0.00%
0/114 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/119 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
0.88%
1/114 • Number of events 1 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/119 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
0.88%
1/114 • Number of events 1 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Developed Equinous Contracture
|
0.84%
1/119 • Number of events 1 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
0.00%
0/114 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Loosening Hardware
|
0.00%
0/119 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
0.88%
1/114 • Number of events 1 • 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place