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

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

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).

Study Overview

• Status: Terminated
• Conditions: Pain; Patient Satisfaction; Wound Healing; Narcotic Consumption
• Intervention / Treatment: Device: Iceman® Cold Therapy unit (djOrtho); Other: Ice

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • OrthoCarolina, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Foot and Ankle Surgery; Please note that the study was terminated prior to randomization of patients.	Device: Iceman® Cold Therapy unit (djOrtho); postoperative cold therapy; Other: Ice; postoperative cold therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale (VAS) Pain Scores	postop day 1 up to postop day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Collaborators: DJO Incorporated
• Investigators: Principal Investigator: Robert B Anderson, MD, OrthoCarolina, PA

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (ESTIMATE): July 31, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2016
• Last Update Submitted That Met QC Criteria: July 21, 2016
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: cryotherapy; postoperative pain; Iceman; primary first metatarsal osteotomy (PMO); lateral ankle ligament reconstruction (LAR)
• Other Study ID Numbers: 020723E