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Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures (Ketotifen)

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ClinicalTrials.gov Identifier: NCT01902017
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : March 27, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
American Society for Surgery of the Hand
Workers' Compensation Board, Alberta
Information provided by (Responsible Party):
Dr. Kevin Hildebrand, University of Calgary

Brief 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.

Condition or disease Intervention/treatment Phase
Joint Contractures Drug: Ketotifen Drug: Placebo Phase 2

Detailed Description:

Individuals ≥ 18 years old with isolated distal 1/3 humerus and/or proximal 1/3 ulna and/or proximal 1/3 radius fractures and/or elbow dislocations (open fractures with or without nerve injury may be included) and presented to Peter Lougheed Centre (PLC), Foothills Medical Center (FMC), or South Health Campus (SHC).

Participants were required to take Ketotifen 5mg by mouth twice a day for 6 weeks or placebo twice a day by mouth for 6 weeks. Neither the participant nor the physician knew if the participant was taking Ketotifen or placebo. Sometimes this type of injury requires surgery. This study invited both patients that do and do not require surgery to participate.

We took a sample of blood to measure tryptase (normally found in the body). We predicted people with high levels of tryptase were more likely to develop stiffening in the joint.

Participants were asked to return for follow up visits 2, 6, 12, 24, and 52 weeks after surgery or date of initial injury if surgery was not required. These visits were part of normal care for this type of injury.

At the visit participants were asked to do the following, some of which was not part of normal care.

At each visit: Range of motion of the elbow was assessed, DASH score was completed- form helping the research group understand the level of disability from this injury, X-rays until the fracture was considered healed (this was normal treatment), SF12 - questionnaire about how the patient was feeling and coping with their injury, Additional information was collected about how the injury was healing and weight was measured.

The participant was required to have physiotherapy which is normal treatment for this injury.

The participant was contacted by telephone at week 1, 3, 4 and 5 while taking the study medication. During these times:

The participant was asked about:

  • any problems with the study medication
  • any new conditions or concerns that have developed

The participant was reminded:

  • of next visit
  • to continue to take study drug as instructed

During these telephone contacts, if any problems were detected that could not be rectified or figured out during the telephone interview, then participant was asked to attend the Cast Clinic to see their doctor in person.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double Blind, Placebo Controlled Trial of Ketotifen in Patients With Elbow Fractures or Dislocations
Study Start Date : June 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Operative, Ketotifen
Ketotifen 5mg orally twice per day for 6 weeks.
Drug: Ketotifen
5 mg PO bid
Other Name: Zaditen

Experimental: Non-operative, Ketotifen
Ketotifen 5mg orally twice per day for 6 weeks.
Drug: Ketotifen
5 mg PO bid
Other Name: Zaditen

Placebo Comparator: Operative, Placebo
Placebo oral medication twice daily for 6 weeks.
Drug: Placebo
5 mg placebo PO bid
Other Name: Lactose Placebo

Placebo Comparator: Non-operative, Placebo
Placebo oral medication twice daily for 6 weeks.
Drug: Placebo
5 mg placebo PO bid
Other Name: Lactose Placebo




Primary Outcome Measures :
  1. Joint range of motion [ Time Frame: 12 months post-injury ]
    Extension-flexion arc of motion


Secondary Outcome Measures :
  1. Range of motion [ Time Frame: 2,6,12,24 and 52 weeks post injury ]
  2. Patients requiring (re)operation for elbow-related causes [ Time Frame: 12 months ]
  3. Radiographic evaluation for fracture healing/non-union [ Time Frame: 12-52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Isolated distal 1/3 humerus fractures
  • Proximal 1/3 ulna fractures
  • Proximal 1/3 radial fractures
  • Elbow dislocations
  • Open fractures with or without nerve injury
  • Presentation to Peter Lougheed Centre (PLC), Foothills Medical Centre (FMC) or South Health Campus (SHC).

Exclusion Criteria:

  • Pre-existing elbow contracture
  • Osteoarthritis of affected elbow
  • Inflammatory arthritis of affected elbow
  • Gout of affected elbow
  • Nonspecific monoarticular arthritis of the affected elbow
  • Inability to give informed consent due to irreversible cognitive disorder
  • Inability to comply with post-operative physiotherapy
  • Injury > 7 days at the time of presentation
  • Inability to mobilize elbow injury within 2 weeks of injury or surgery
  • Pregnancy
  • Breast feeding
  • Oral hypoglycemic medications
  • History of epilepsy
  • Lactose intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902017


Locations
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Canada, Alberta
Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y 6J4
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 1N4
South Health Campus
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
American Society for Surgery of the Hand
Workers' Compensation Board, Alberta
Investigators
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Principal Investigator: Kevin Hildebrand, MD University of Calgary

Publications:
Kopka M, Zhang M, Schneider PS, Fan C-Y, Liang X, Hart DA, Befus A Dean, Garven A, Salo P, Hildebrand KA. Human Serum Mast Cell Tryptase Levels in Elbow Fractures and Dislocations. Transactions of the Orthopaedic Research Society; 41:1190, 2016.

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Responsible Party: Dr. Kevin Hildebrand, Orthopaedic Surgeon, University of Calgary
ClinicalTrials.gov Identifier: NCT01902017     History of Changes
Other Study ID Numbers: REB15-0081
REB15-0081 ( Other Identifier: Conjoint Health Research Ethics Board )
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by Dr. Kevin Hildebrand, University of Calgary:
Joint
Contracture
Elbow
Fracture
Dislocation

Additional relevant MeSH terms:
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Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Ketotifen
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents