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recruitment feasability
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| Name | Class |
|---|---|
| DJO Incorporated | INDUSTRY |
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This study will compares differences in pain level, narcotic consumption, wound healing, patient satisfaction in patients randomized to the Iceman® cold pack therapy system (djOrtho, Inc) versus those who use ice. This will be assessed postoperatively following the foot and ankle procedures primary first metatarsal osteotomy (PMO) or lateral ankle ligament reconstruction (LAR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Foot and Ankle Surgery | Other | Please note that the study was terminated prior to randomization of patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iceman® Cold Therapy unit (djOrtho) | Device | postoperative cold therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores | postop day 1 up to postop day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Pain Medication Usage | postop day 1 up to postop day 14 | |
| Patient Satisfaction | first postoperative visit (between postop day 10 and 14) | |
| Surgical Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert B Anderson, MD | OrthoCarolina, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoCarolina, PA | Charlotte | North Carolina | 28203 | United States |
The study was terminated before patients were randomized to the treatment arms. Thus, it is not possible to report the results for the individual treatment arms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Foot and Ankle Surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ice |
| Other |
postoperative cold therapy |
|
| Day of Surgery |
| Postoperative Complications | postop day 1 up to postop day 14 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Foot and Ankle Surgery | Our target enrollment was 82 participants. We only enrolled 36 participants. The study was terminated due to low enrollment. As a result, patients were never randomized. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) Pain Scores | Data not analyzed due to study termination | Posted | postop day 1 up to postop day 14 |
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| Secondary | Narcotic Pain Medication Usage | Data not analyzed due to study termination. | Posted | postop day 1 up to postop day 14 |
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| Secondary | Patient Satisfaction | Data not analyzed due to study termination | Posted | first postoperative visit (between postop day 10 and 14) |
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| Secondary | Surgical Complications | Data not analyzed due to study termination | Posted | Day of Surgery |
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| Secondary | Postoperative Complications | Data not analyzed due to study termination | Posted | postop day 1 up to postop day 14 |
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There were no adverse events at time of study termination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Foot and Ankle Surgery | 0 | 36 | 0 | 36 |
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The study was stopped due to poor enrollment. No results are available
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert B. Anderonson | OrthoCarolina | 704-323-2000 | robert.anderson@orthocarolina.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| D017060 | Patient Satisfaction |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D007053 | Ice |
| ID | Term |
|---|---|
| D014867 | Water |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D014887 | Weather |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
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