Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
Conditions
Keywords
cryotherapy, postoperative pain, Iceman, primary first metatarsal osteotomy (PMO), lateral ankle ligament reconstruction (LAR)
Brief summary
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).
Interventions
DEVICEIceman® Cold Therapy unit (djOrtho)
postoperative cold therapy
OTHERIce
postoperative cold therapy
Sponsors
DJO Incorporated
OrthoCarolina Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled to have either lateral ankle ligament reconstruction (LAR) surgery or primary first metatarsal osteotomy surgery * Patients who agree to be compliant and to keep a patient diary daily for 2 weeks and to return to the clinic for a 2 week postoperative follow- up appointment
Exclusion criteria
* Patients with Diabetes Mellitus, peripheral vascular disease, Reynauds Syndrome, hypersensitivity to cold * Patients allergic to hydrocodone or oxycodone * Patients who are unwilling to complete the patient diary and/or follow their specific cold therapy instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale (VAS) Pain Scores | postop day 1 up to postop day 14 |
Secondary
| Measure | 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 | Day of Surgery |
| Postoperative Complications | postop day 1 up to postop day 14 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Foot and Ankle Surgery |
|---|---|
| Age, Continuous | 56 Years |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Visual Analog Scale (VAS) Pain Scores
Time frame: postop day 1 up to postop day 14
Population: Data not analyzed due to study termination
Secondary
Narcotic Pain Medication Usage
Time frame: postop day 1 up to postop day 14
Population: Data not analyzed due to study termination.
Secondary
Patient Satisfaction
Time frame: first postoperative visit (between postop day 10 and 14)
Population: Data not analyzed due to study termination
Secondary
Postoperative Complications
Time frame: postop day 1 up to postop day 14
Population: Data not analyzed due to study termination
Secondary
Surgical Complications
Time frame: Day of Surgery
Population: Data not analyzed due to study termination