Acetabular FractureNCT01763359
Hip Strength and Nerve Palsy After the Modified Stoppa Approach to Acetabular Fracture Reduction and Fixation
An observational study of Acetabular Fracture and Pelvic Fracture, run by University of Utah at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Acetabular Fracture, Pelvic Fracture
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedics Center
Salt Lake City, Utah, 84121
About this study
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?
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).
- Conditions
- Acetabular Fracture, Pelvic Fracture
- Keywords
- acetabular fracture, pelvic fracture, hip adductor strength, obturator nerve palsy, modified Stoppa approach
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Outpatient physical therapy strength testing will be used to assess hip adductor strength in all participants (subjects and controls).
Measured: 1 year follow-up after surgery
Secondary outcomes (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).
Measured: 1 year follow-up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionFeb 2020
- Study completionFeb 2020
Why it stopped: The original PI moved on from this facility as did other key personnel. The current PI decided to discontinue the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FractureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rothberg, University of Utah
- Investigators
- David Rothberg, MD, Principal investigator, Orthopedic Surgery Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763359
- Sponsor's protocol ID
- 55695
- Status last verified
- Apr 2020
- First submitted
- 4 Jan 2013
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT01763359
- Acronym / sponsor ID
- 55695
- Conditions
- Acetabular Fracture, Pelvic Fracture
- Keywords
- acetabular fracture, pelvic fracture, hip adductor strength, obturator nerve palsy, modified Stoppa approach
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The original PI moved on from this facility as did other key personnel. The current PI decided to discontinue the study.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: The original PI moved on from this facility as did other key personnel. The current PI decided to discontinue the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
Related trials for Acetabular Fracture
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Active, not recruitingPhase 2
Stoppa Approach Vs Anterior & Posterior Fixation in Management of BC Fracture Acetabulum
Evaluation of Isolated Stoppa Approach in BC Fracture Acetabulum
RecruitingObservational study
Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
Recruiting
Pericapsular Nerve Group (PENG) Block on Postoperative Pain Management After Acetabular Fracture Fixation
Acetabular Fractures
Not yet recruitingObservational study
Functional and Radiological Outcomes of Pediatric Acetabular Fracture Management
Acetabular Fractures in Pediatrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rothberg, MD principal investigator
Orthopedic Surgery Operations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetabular Fracture and Pelvic Fracture, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The original PI moved on from this facility as did other key personnel. The current PI decided to discontinue the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.