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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Narcotic Consumption Pain Wound Healing Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Foot and Ankle Surgery

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

Group Type OTHER

Iceman® Cold Therapy unit (djOrtho)

Intervention Type DEVICE

postoperative cold therapy

Ice

Intervention Type OTHER

postoperative cold therapy

Interventions

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Iceman® Cold Therapy unit (djOrtho)

postoperative cold therapy

Intervention Type DEVICE

Ice

postoperative cold therapy

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No