Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
Stopped early · Phase 4
Conditions studied: Narcotic Consumption, Pain, Wound Healing, Patient Satisfaction
In brief
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).
Key facts
- Study ID
- NCT00950183
- Run by
- OrthoCarolina Research Institute, Inc.
- People needed
- 36
- Starts
- 2007-02-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2016-08-22
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- OrthoCarolina, PA — Charlotte, North Carolina, United States
Full record on ClinicalTrials.gov
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