Text Size

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
History of Changes
  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:

U.S. FDA Resources

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
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 June 18, 2013