Status:
TERMINATED
Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Collaborating Sponsors:
DJO Incorporated
Conditions:
Narcotic Consumption
Pain
Eligibility:
All Genders
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00950183
Start Date
February 1 2007
End Date
December 1 2010
Last Update
August 22 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28203