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

Acetabular Fracture Clinical Trial

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?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01763359
• Other study ID #: 55695
• Status: Terminated
• Start date: April 2012
• Est. completion date: February 2020

Study information

• Verified date: April 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acetabular Fracture
• Fractures, Bone
• Hip Fractures
• Pelvic Fracture

Locations

Country	Name	City	State
United States	University of Utah Orthopedics Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outpatient physical therapy strength testing will be used to assess hip adductor strength in all participants (subjects and controls).		1 year follow-up after surgery
Secondary	Radiographs and clinical assessment at follow-up appointments will be used to determine incidence of obturator nerve palsy in both groups (subjects and controls).		1 year follow-up after surgery