Hip Strength and Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Eric Kubiak, University of Utah
First received: January 4, 2013
Last updated: January 5, 2015
Last verified: January 2015
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).
||Observational Model: Cohort
Time Perspective: Prospective
||Decreased Hip Adductor Strength and Obturator Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation: Is Retraction to Blame?
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01763359
|University of Utah Orthopedics Center
|Salt Lake City, Utah, United States, 84121 |
University of Utah
||Orthopedic Surgery Operations
No publications provided
||Eric Kubiak, M.D., University of Utah
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2013
||January 5, 2015
||United States: Institutional Review Board
United States: Food and Drug Administration
Keywords provided by University of Utah:
hip adductor strength
obturator nerve palsy
modified Stoppa approach
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 30, 2015
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