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

NCT00950183 | Terminated Phase 4 Results DMC

• 1 other identifier: 020723E
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Narcotic Consumption; Pain; Wound Healing; Patient Satisfaction

Keywords

cryotherapy; postoperative pain; Iceman; primary first metatarsal osteotomy (PMO); lateral ankle ligament reconstruction (LAR)

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS) Pain Scores

  postop day 1 up to postop day 14

Secondary Outcomes (4)

• 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

Study Arms (1)

Foot and Ankle Surgery

OTHER

Please note that the study was terminated prior to randomization of patients.

Device: Iceman® Cold Therapy unit (djOrtho); Other: Ice

Interventions

Iceman® Cold Therapy unit (djOrtho) DEVICE

postoperative cold therapy

Foot and Ankle Surgery

Ice OTHER

postoperative cold therapy

Foot and Ankle Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead
• DJO Incorporated: collaborator

Study Sites (1)

OrthoCarolina, PA

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Pain; Patient Satisfaction; Pain, Postoperative

Interventions

Ice

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health

Limitations and Caveats

The study was stopped due to poor enrollment. No results are available

Results Point of Contact

• Title: Dr. Robert B. Anderonson
• Organization: OrthoCarolina

robert.anderson@orthocarolina.com

704-323-2000

Study Officials

• Robert B Anderson, MD

  OrthoCarolina, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 31, 2009
• Study Start: February 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 22, 2016
• Results First Posted: November 4, 2014

Record last verified: 2014-10

Locations

US (1)