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

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.
 
ClinicalTrials.gov Identifier: NCT01763359
Recruitment Status : Terminated (The original PI moved on from this facility as did other key personnel. The current PI decided to discontinue the study.)
First Posted : January 8, 2013
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
David Rothberg, University of Utah

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
Acetabular Fracture Pelvic Fracture

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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 : April 2012
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  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). [ Time Frame: 1 year follow-up after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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.

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
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United States, Utah
University of Utah Orthopedics Center
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: David Rothberg, MD Orthopedic Surgery Operations
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Responsible Party: David Rothberg, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01763359    
Other Study ID Numbers: 55695
First Posted: January 8, 2013    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
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:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries