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

Phase 4

Terminated

• Conditions: Pain; Patient Satisfaction; Narcotic Consumption; Wound Healing
• Interventions: Device: Iceman® Cold Therapy unit (djOrtho); Other: Ice

• Registration Number: NCT00950183
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-03-11
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-28
• Results First Posted: 2014-11-04
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foot and Ankle Surgery	Ice	Please note that the study was terminated prior to randomization of patients.
Foot and Ankle Surgery	Iceman® Cold Therapy unit (djOrtho)	Please note that the study was terminated prior to randomization of patients.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Scores	postop day 1 up to postop day 14

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

OrthoCarolina, PA; 🇺🇸 Charlotte, North Carolina, United States