Hip Strength and Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation

Sponsor
University of Utah (Other)
Overall Status
Terminated
CT.gov ID
NCT01763359
Collaborator
(none)
43
1
94
0.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    43 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Decreased Hip Adductor Strength and Obturator Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation: Is Retraction to Blame?
    Study Start Date :
    Apr 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2020
    Actual Study Completion Date :
    Feb 1, 2020

    Outcome Measures

    Primary Outcome Measures

    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 Outcome Measures

    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

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Inclusion criteria for the subject patient population under study consists of male and female adults, at least 18 years old, who had an acetabular fracture that was treated with the modified Stoppa approach.

    • Inclusion criteria for the control patient population under study consists of male and female adults, at least 18 years old, who had acetabular fractures with similar fracture patterns as the study group that were treated with any other approach than the Stoppa approach.

    Exclusion Criteria:
    • Exclusion criteria for the subject and control patient population consist of:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah Orthopedics Center Salt Lake City Utah United States 84121

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: David Rothberg, MD, Orthopedic Surgery Operations

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Rothberg, M.D., University of Utah
    ClinicalTrials.gov Identifier:
    NCT01763359
    Other Study ID Numbers:
    • 55695
    First Posted:
    Jan 8, 2013
    Last Update Posted:
    May 4, 2020
    Last Verified:
    Apr 1, 2020
    Keywords provided by David Rothberg, M.D., University of Utah
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 4, 2020