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Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures

NCT01902017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2018-03-27

No results posted yet for this study

Summary

Injured joints, especially at the elbow, are at risk for permanent motion loss, also known as joint contractures. Joint contractures limit the function of an elbow and are a recognized complication that occurs often after a traumatic injury. The benefits of early motion after injury has helped in preventing joint contractures but there are still several patients that develop debilitating joint contractures. Current research suggests that mast cells, which are found in the joint, are key in causing joint contractures. Research has been done using a medication called Ketotifen. Ketotifen has been linked to stabilizing mast cells and preventing the joint contracture. It is hoped that short-term use of this medication after an injury will prevent the contracture from occurring.

Conditions

  • Joint Contractures

Interventions

DRUG

Ketotifen

5 mg PO bid

DRUG

Placebo

5 mg placebo PO bid

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • American Society for Surgery of the Hand

    collaborator OTHER

  • Workers' Compensation Board, Alberta

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Kevin Hildebrand, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01902017 on ClinicalTrials.gov