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

This study has been terminated.
(recruitment feasability)
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT00950183
First received: July 29, 2009
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

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 two different foot and ankle procedures: 1) primary first metatarsal osteotomy (PMO) and 2) lateral ankle ligament reconstruction (LAR).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Narcotic pain medication usage [ Time Frame: postop day 1 up to postop day 14 ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: first postoperative visit (between postop day 10 and 14) ] [ Designated as safety issue: No ]
  • Surgical complications [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
  • Postoperative complications [ Time Frame: postop day 1 up to postop day 14 ] [ Designated as safety issue: No ]

Enrollment: 82
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
primary first metatarsal osteotomy Device: Iceman® Cold Therapy unit (djOrtho)
postoperative cold therapy
Other: Ice
postoperative cold therapy
lateral ankle ligament reconstruction Device: Iceman® Cold Therapy unit (djOrtho)
postoperative cold therapy
Other: Ice
postoperative cold therapy

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950183

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

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00950183     History of Changes
Other Study ID Numbers: 020723E
Study First Received: July 29, 2009
Last Updated: January 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by OrthoCarolina Research Institute, Inc.:
cryotherapy
postoperative pain
Iceman
primary first metatarsal osteotomy (PMO)
lateral ankle ligament reconstruction (LAR)

ClinicalTrials.gov processed this record on July 28, 2014