Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00950183
• Other study ID #: 020723E
• Status: Terminated
• Phase: Phase 4
• First received: July 29, 2009
• Last updated: October 28, 2014
• Start date: February 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2014
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Narcotic Consumption
• Pain
• Patient Satisfaction
• Wound Healing

Intervention

Device:
• Iceman® Cold Therapy unit (djOrtho)
postoperative cold therapy

Other:
• Ice
postoperative cold therapy

Locations

Country	Name	City	State
United States	OrthoCarolina, PA	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.	DJO Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS) Pain Scores		postop day 1 up to postop day 14	No
Secondary	Narcotic Pain Medication Usage		postop day 1 up to postop day 14	No
Secondary	Patient Satisfaction		first postoperative visit (between postop day 10 and 14)	No
Secondary	Surgical Complications		Day of Surgery	No
Secondary	Postoperative Complications		postop day 1 up to postop day 14	No