Study Stopped
The original PI moved on from this facility as did other key personnel. The current PI decided to discontinue the study.
Hip Strength and Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation
Decreased Hip Adductor Strength and Obturator Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation: Is Retraction to Blame?
1 other identifier
observational
43
1 country
1
Brief Summary
The purpose of this prospective study is to compare hip adductor strength and obturator nerve palsy between acetabular fracture patients whose fracture was reduced and fixated using the modified Stoppa approach (subjects) and pelvic fracture patients (controls) using physical strength testing, radiographs, clinical assessment, and a validated functional outcome questionnaire. The investigators' research hypothesis is that there will be less strength and higher incidence of obturator nerve palsy in patients treated with the modified Stoppa approach (intervention) than in patients treated without the modified Stoppa approach (controls).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 4, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMay 4, 2020
April 1, 2020
7.8 years
January 4, 2013
April 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Outpatient physical therapy strength testing will be used to assess hip adductor strength in all participants (subjects and controls).
1 year follow-up after surgery
Secondary Outcomes (1)
Radiographs and clinical assessment at follow-up appointments will be used to determine incidence of obturator nerve palsy in both groups (subjects and controls).
1 year follow-up after surgery
Eligibility Criteria
Pelvic fracture patients and patients treated for acetabular fractures with the modified Stoppa approach will be asked to consent to a voluntary study investigating physical function at their 2 week follow-up appointment.
You may not qualify if:
- Patients who are non-ambulatory.
- Patients less than 18 years of age.
- Patients who do not speak English.
- Patients who are unable to complete their follow-up in Utah.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah Orthopedics Center
Salt Lake City, Utah, 84121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Rothberg, MD
Orthopedic Surgery Operations
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
January 4, 2013
First Posted
January 8, 2013
Study Start
April 1, 2012
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
May 4, 2020
Record last verified: 2020-04