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

This study has been terminated.
(recruitment feasability)
DJO Incorporated
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc. Identifier:
First received: July 29, 2009
Last updated: July 21, 2016
Last verified: October 2014
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).

Condition Intervention Phase
Narcotic Consumption
Wound Healing
Patient Satisfaction
Device: Iceman® Cold Therapy unit (djOrtho)
Other: Ice
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) Pain Scores [ Time Frame: postop day 1 up to postop day 14 ]

Secondary Outcome Measures:
  • Narcotic Pain Medication Usage [ Time Frame: postop day 1 up to postop day 14 ]
  • Patient Satisfaction [ Time Frame: first postoperative visit (between postop day 10 and 14) ]
  • Surgical Complications [ Time Frame: Day of Surgery ]
  • Postoperative Complications [ Time Frame: postop day 1 up to postop day 14 ]

Enrollment: 36
Study Start Date: February 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00950183

United States, North Carolina
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
DJO Incorporated
Principal Investigator: Robert B Anderson, MD OrthoCarolina, PA
  More Information

Responsible Party: OrthoCarolina Research Institute, Inc. Identifier: NCT00950183     History of Changes
Other Study ID Numbers: 020723E
Study First Received: July 29, 2009
Results First Received: March 11, 2013
Last Updated: July 21, 2016

Keywords provided by OrthoCarolina Research Institute, Inc.:
postoperative pain
primary first metatarsal osteotomy (PMO)
lateral ankle ligament reconstruction (LAR) processed this record on May 23, 2017