The Canadian Prospective Pragmatic Perilunate Outcomes Trial

ConditionsWrist Injuries Carpal Bone Fracture Dislocation of Wrist Trauma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age14-120

SponsorUniversity of Calgary

About this trial

This is a unique three-fold prospective and retrospective study. With this approach, all previous and current PLIs presented at participating study sites will have the potential to be included in the study. Our goal is to collect all relevant injury and surgical parameters of the Perilunate spectrum. The investigators plan to identify each hospital within Canada that normally treats PLIs and to record injury and demographic information on each PLI that occurs in this country over a two to three-year period. Our protocol includes scheduled two, five, and 10-year follow-up intervals.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The subject is 14 years of age or older

The subject has been clinically diagnosed with a perilunate injury

The subject is willing to adhere to the study protocol including required post-operative therapy, all scheduled follow-up visits, evaluations, and questionnaires (if applicable).

Disqualifiers

None

Trial population

Patients who sustain a perilunate spectrum injury including dislocation and/or fracture.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

450 Participants

are grouped into 3 trial groups

Group A: Registry Group

Group B: Prospective Group

Group C: Retrospective Group

Trial outcomes

Primary outcomes

Disabilities of the Arm, Shoulder and Hand (DASH)

The upper extremity scoring scale DASH is a validated tool for disorders of the elbow with a range from 0 (least disability) to 100 (most disability). Ten is the average score in the general population and the minimal clinically important difference (MCID) is 10. DASH contains 30 questions asking participants about their ability to perform activities and their symptoms. Each question ranges from 1 (no difficulty) to 5 (unable). There is also optional work and sports/performing arts modules.

Time frame

Enrollment - 10 years

Secondary outcomes

Radiographs

Radiographic evaluation for fracture healing and/or nonunion, and the number of participants requiring re-operation for contracture and also composite re-operation for all perilunate fractures and/or dislocations related causes. This will be completed by a radiologist.

Time frame

Enrollment - 10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

University of Alberta

Collaborator

Source ClinicalTrials.gov

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