Trial Outcomes & Findings for Management of Traumatic Bone Defects in Tibial Plateau Fractures With Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial (NCT NCT02456194)
NCT ID: NCT02456194
Last Updated: 2023-09-21
Results Overview
Number of participants with any study device remaining visible on CT
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2023-09-21
Participant Flow
Participant milestones
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
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|---|---|
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Age, Continuous
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53.3 years
STANDARD_DEVIATION 12.8 • n=30 Participants
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Sex: Female, Male
Female
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17 Participants
n=30 Participants
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Sex: Female, Male
Male
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13 Participants
n=30 Participants
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Region of Enrollment
Canada
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30 participants
n=30 Participants
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PRIMARY outcome
Timeframe: 6 monthsNumber of participants with any study device remaining visible on CT
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
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|---|---|
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Resorption of Study Device
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4 Participants
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SECONDARY outcome
Timeframe: BaselineSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
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|---|---|
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Knee Injury Osteoarthritis Outcome Score - Pain Subscale
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89.0 score on a scale
Standard Deviation 18.6
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SECONDARY outcome
Timeframe: 6 weeksRange of knee motion (active flexion) in degrees
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=26 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
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|---|---|
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Range of Motion
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97.38 degrees
Standard Deviation 27.42
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SECONDARY outcome
Timeframe: 6 weeks, 3 months, 6 months, 12 monthsAmount of collapse of the joint surface, measured in mm, on plain x-ray. Reported as number of participants with at least 2mm of subsidence on x-ray.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
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|---|---|
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Subsidence of Joint Surface
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4 Participants
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SECONDARY outcome
Timeframe: 6 weeksSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Pain Subscale
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51.71729611 score on a scale
Standard Deviation 23.47939809
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SECONDARY outcome
Timeframe: 3 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
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62.18 score on a scale
Standard Deviation 23.07
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SECONDARY outcome
Timeframe: 6 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Pain Subscale
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70.21 score on a scale
Standard Deviation 21.76
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SECONDARY outcome
Timeframe: 12 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Pain Subscale
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75.38 score on a scale
Standard Deviation 19.60
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SECONDARY outcome
Timeframe: BaselineSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
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89.29 score on a scale
Standard Deviation 14.85
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SECONDARY outcome
Timeframe: 6 weeksSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
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55.79 score on a scale
Standard Deviation 20.63
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SECONDARY outcome
Timeframe: 6 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
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62.86 score on a scale
Standard Deviation 23.32
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SECONDARY outcome
Timeframe: 3 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
|
57.98 score on a scale
Standard Deviation 22.44
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SECONDARY outcome
Timeframe: 12 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Symptoms Subscale
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70.69 score on a scale
Standard Deviation 18.37
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SECONDARY outcome
Timeframe: BaselineSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
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92.24 score on a scale
Standard Deviation 17.00
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SECONDARY outcome
Timeframe: 6 weeksSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
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50.37 score on a scale
Standard Deviation 23.92
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SECONDARY outcome
Timeframe: 3 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
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67.42 score on a scale
Standard Deviation 21.98
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SECONDARY outcome
Timeframe: 6 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
|
74.54 score on a scale
Standard Deviation 19.45
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SECONDARY outcome
Timeframe: 12 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Activities of Daily Living Subscale
|
81.68 score on a scale
Standard Deviation 16.51
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SECONDARY outcome
Timeframe: BaselineSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
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81.9 score on a scale
Standard Deviation 28.5
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SECONDARY outcome
Timeframe: 6 weeksSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
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14.62 score on a scale
Standard Deviation 29.81
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SECONDARY outcome
Timeframe: 3 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
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22.93 score on a scale
Standard Deviation 22.12
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SECONDARY outcome
Timeframe: 6 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
|
39.17 score on a scale
Standard Deviation 35.78
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SECONDARY outcome
Timeframe: 12 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Sports/Recreation Subscale
|
53.5 score on a scale
Standard Deviation 28.49
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SECONDARY outcome
Timeframe: BaselineSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
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85.34 score on a scale
Standard Deviation 26.8
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SECONDARY outcome
Timeframe: 6 weeksSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
|
25 score on a scale
Standard Deviation 22.46
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SECONDARY outcome
Timeframe: 3 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
|
35.83 score on a scale
Standard Deviation 23.93
|
SECONDARY outcome
Timeframe: 6 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
|
46.04 score on a scale
Standard Deviation 27.07
|
SECONDARY outcome
Timeframe: 12 monthsSelf-reported outcome score, reported as the mean score at each time point. Scale 0-100, 100 is best.
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Knee Injury Osteoarthritis Outcome Score - Quality of Life Subscale
|
58.98 score on a scale
Standard Deviation 23.47
|
SECONDARY outcome
Timeframe: 3 monthsRange of knee motion (active flexion) in degrees
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=27 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Range of Motion
|
108.52 degrees
Standard Deviation 25.35
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SECONDARY outcome
Timeframe: 6 monthsRange of knee motion (active flexion) in degrees
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Range of Motion
|
121.20 degrees
Standard Deviation 19.98
|
SECONDARY outcome
Timeframe: 12 monthsRange of knee motion (active flexion) in degrees
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Range of Motion
|
126.51 degrees
Standard Deviation 11.87
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SECONDARY outcome
Timeframe: 3 monthsNumber of participants with any study device remaining visible on x-ray
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=29 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Resorption of Study Device
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsNumber of participants with any study device remaining visible on x-ray
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Resorption of Study Device
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 monthsNumber of participants with any study device remaining visible on x-ray
Outcome measures
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 Participants
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
|
Resorption of Study Device
|
0 Participants
|
Adverse Events
Calcium Sulfate + Antibiotics + Internal Fixation
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 participants at risk
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
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|---|---|
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Musculoskeletal and connective tissue disorders
articular surface apoptosis
|
3.3%
1/30 • 1 year
|
Other adverse events
| Measure |
Calcium Sulfate + Antibiotics + Internal Fixation
n=30 participants at risk
Calcium Sulfate + Antibiotics + Internal Fixation: STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
|
|---|---|
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Infections and infestations
Infection
|
6.7%
2/30 • 1 year
|
|
Musculoskeletal and connective tissue disorders
intra-articular heterotopic bone formation
|
3.3%
1/30 • 1 year
|
|
Musculoskeletal and connective tissue disorders
hardware irritation
|
10.0%
3/30 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place