Recruiting

Observational Study

Sponsor:

University of Calgary

Code:

NCT04370626

Conditions

Wrist Injuries

Carpal Bone Fracture

Dislocation of Wrist

Trauma

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Wrist Injuries

Carpal Bone Fracture

Dislocation of Wrist

Trauma

Study ID

NCT04370626

Start date

Sep 1, 2020

Status verified date

May, 2022

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

There will be no limiting exclusion criteria.

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

Registry Group

Patients who sustain and present with a PLI injury will have two options for participating in the study. This first arm will evaluate clinical presentations, patient demographic, treatment methods and baseline patient-rated and radiographic outcomes. However, no research-related follow up visits will be conducted. Ongoing data from these participants will be collected from chart reviews of clinical follow-ups alone.

Prospective Group

Participants who choose to enroll in the prospective arm will experience the same baseline data collection as those in the registry, with the addition of research-related follow up appointments that will allow research staff to measure and assess patient-rated and clinical outcomes, such as questionnaires and range of motion data.

Retrospective Group

In this group, a chart review will be conducted to identify previously treated patients with perilunate injuries. Once identified, the patient will be contacted and ask if they are willing to come in for a long-term follow up visit where clinical, patient-rated, and radiographic data will be collected. If patients are unwilling to attend a long-term visit, our analysis will still include data collected from their chart reviews and electronic questionnaires.

Primary outcome measure

  • Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: Enrollment - 10 years ]

Central Contacts and Locations

Central contacts

Adina Tarcea, BMSc

4039563687adina.tarcea@ucalgary.ca

Sarah L Reitzel, BN

403-956-1971slreitze@ucalgary.ca

Locations

South Health Campus

Recruiting

Calgary, Alberta, Canada, T3M1M4

Contacts

Tina Samuel, MBBS

4039563687

Principal Investigator:

Neil J White, MD

More Information

Sponsor

University of Calgary

Last update posted

Nov 23, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-11-23.