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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00950183
Recruitment Status : Terminated (recruitment feasability)
First Posted : July 31, 2009
Results First Posted : November 4, 2014
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Study Description
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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).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950183


Locations
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United States, North Carolina
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
DJO Incorporated
Investigators
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Principal Investigator: Robert B Anderson, MD OrthoCarolina, PA
More Information
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Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00950183    
Other Study ID Numbers: 020723E
First Posted: July 31, 2009    Key Record Dates
Results First Posted: November 4, 2014
Last Update Posted: August 22, 2016
Last Verified: October 2014
Keywords provided by OrthoCarolina Research Institute, Inc.:
cryotherapy
postoperative pain
Iceman
primary first metatarsal osteotomy (PMO)
lateral ankle ligament reconstruction (LAR)