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

OrthoCarolina Research Institute, Inc.

Status and phase: Terminated; Phase 4

Conditions: Patient Satisfaction; Wound Healing; Pain; Narcotic Consumption

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00950183

020723E

Details and patient eligibility

About

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).

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 1 patient group

Foot and Ankle Surgery

Other group

Description:

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

Treatment:

Device: Iceman® Cold Therapy unit (djOrtho)

Other: Ice