Clinical trial NCT01763359: Hip Strength and Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acetabular Fracture
Pelvic Fracture
Keywords: acetabular fracture
pelvic fracture
hip adductor strength
obturator nerve palsy
modified Stoppa approach
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility 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.

Primary outcomes:
measure: Outpatient physical therapy strength testing will be used to assess hip adductor strength in all participants (subjects and controls).
timeFrame: 1 year follow-up after surgery
Secondary outcomes:
measure: Radiographs and clinical assessment at follow-up appointments will be used to determine incidence of obturator nerve palsy in both groups (subjects and controls).
timeFrame: 1 year follow-up after surgery
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopedics Center
state: Utah
Study officials:
affiliation: Orthopedic Surgery Operations
name: David Rothberg, MD
role: PRINCIPAL_INVESTIGATOR
References: