Skip to content

The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01104831
Acronym
ARCTIC CAT
Enrollment
20
Registered
2010-04-16
Start date
2010-04-30
Completion date
2012-11-30
Last updated
2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal Tibia Fracture

Keywords

Tibial Plateau Fracture, AO/OTA 41

Brief summary

Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored. Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement

Interventions

DEVICECryotherapy

cooled sleeve placed over fracture site.

DEVICERoom temperature cuff

sleeve with room temperature water placed over fracture site.

Sponsors

Orthopedic Research and Education Foundation
CollaboratorOTHER
Orthopedic Trauma Association
CollaboratorUNKNOWN
University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Skeletally mature * Trauma patients with single-system musculoskeletal injuries. * Proximal tibia fractures treated with open reduction and internal fixation. * Unilateral proximal tibial injuries.

Exclusion criteria

* Previous ipsilateral knee surgery * Upper extremity injuries impairing mobilization * Pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury * Associated injuries impairing mobilization * Suspected or confirmed compartment syndrome * Open fractures * Patients previously on narcotics * Patients with impaired sensorium Concurrent head injury Intoxication

Design outcomes

Primary

MeasureTime frame
Cost3 months

Secondary

MeasureTime frame
VAS Pain Score2 weeks
Narcotic Requirements2 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026