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

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01763359
First Posted: January 8, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Rothberg, University of Utah
  Purpose
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
Acetabular Fracture Pelvic Fracture

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by David Rothberg, University of Utah:

Primary Outcome Measures:
  • Outpatient physical therapy strength testing will be used to assess hip adductor strength in all participants (subjects and controls). [ Time Frame: 1 year follow-up after surgery ]

Secondary Outcome Measures:
  • Radiographs and clinical assessment at follow-up appointments will be used to determine incidence of obturator nerve palsy in both groups (subjects and controls). [ Time Frame: 1 year follow-up after surgery ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763359


Locations
United States, Utah
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
  More Information

Responsible Party: David Rothberg, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01763359     History of Changes
Other Study ID Numbers: 55695
First Submitted: January 4, 2013
First Posted: January 8, 2013
Last Update Posted: October 26, 2017
Last Verified: August 2017

Keywords provided by David Rothberg, University of Utah:
acetabular fracture
pelvic fracture
hip adductor strength
obturator nerve palsy
modified Stoppa approach

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries