Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures: An Evaluation of Narcotic Consumption, Pain, Wound Healing, and Patient Satisfaction

OrthoCarolina Research Institute, Inc.1 site in 1 country36 target enrollmentFebruary 2007

ConditionsNarcotic Consumption Pain Wound Healing Patient Satisfaction

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Narcotic Consumption
Sponsor: OrthoCarolina Research Institute, Inc.
Enrollment: 36
Locations: 1
Primary Endpoint: Visual Analog Scale (VAS) Pain Scores
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

December 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OrthoCarolina Research Institute, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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