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:
Information provided by (Responsible Party):
Eric Kubiak, University of Utah
ClinicalTrials.gov Identifier:
NCT01763359
First received: January 4, 2013
Last updated: June 18, 2014
Last verified: June 2014
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: Erik Kubiak Orthopedic Surgery Operations
  More Information

No publications provided

Responsible Party: Eric Kubiak, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01763359     History of Changes
Other Study ID Numbers: 55695
Study First Received: January 4, 2013
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 20, 2014