Pelvic and Acetabular Fracture: A Prospective Observational Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
The purpose of this study is to understand the trajectory of function and self-reported outcomes of patients following pelvic and acetabular, treated both operatively and nonoperatively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fracture of the pelvic ring
Fracture of the acetabulum
Disqualifiers
Patients unwilling to provide consent to participate.
Trial population
Patients treated for pelvic or acetabular fracture at an orthopaedic trauma practices.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Operative
Procedure/Surgerysurgical treatment
Nonoperative
Procedure/Surgerynonsurgical treatment
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Pelvic Ring Fracture2 interventions
Group B: Acetabular Fracture2 interventions
Trial outcomes
Primary outcomes
1
Return to work/activities
Average time to return to work and activities
Time frame
0-24 months following injurySecondary outcomes
1
Change in patient-reported outcomes measurement information system (PROMIS 29) scores
The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
Time frame
baseline, 3, 6, 12 and 24 months2
Fracture Healing
Union rates as measured clinically and radiographically. Xrays will be collected from the electronic medical record.
Time frame
0-24 months following injury3
Complications
Rates of readmission, reoperations and complications
Time frame
0-24 months following injury4
Performance Measure- 10 meter walk test
Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject.
Time frame
3, 6, 12 and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov