Static Balance Disorders in Patients After Surgical Treatment of Hip Acetabular Fractures

Static Balance Disorders in Patients After ( (ORIF) Surgical Treatment of Hip Acetabular Fractures

The mechanism of maintaining balance is a complex phenomenon, involving numerous systems of human body. High-energy trauma resulting in acetabular fracture damages some of the elements composing this delicate mechanism, potentially increasing the risk of falls in patients. There have not been any studies so far on balance levels in patients after surgical treatment of acetabular fractures.

Questions/purposes

  1. Do balance disorders occur in patients after ORIF of acetabular fractures?
  2. Do surgical approach and fracture pattern influence balance level of patients?
  3. Should therapy programs include certain stabilometric parameters adequate especially for this type of injury?

Study Overview

Detailed Description

Methods Between 2014-2017, investigators evaluated 110 subjects: 55 patients after surgical treatment of acetabular fracture - the study population (mean age 43.6 ± 14.8 years) and 55 healthy subjects - the clinical control group (mean age 43.8 ± 14.9 years).

To ensure reliability of results, controls were individually matched to appropriate study population patients, in terms age, sex, body height and mass.

The study was conducted in Public Hospital and the protocol was approved by the Commission of Ethics (SKE 01-21/2014).

Investigators measured static balance in double leg stance (eyes open/eyes closed) for 30s on CQStab2P, a double module stabilometric platform.

The pain component of the Harris Hip score and the quality of fracture reduction (according to Matta's criteria) in digitized anteroposterior and two oblique view radiographs were analyzed.

Study Type

Observational

Enrollment (Actual)

110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population involved 55 patients after surgical treatment of hip acetabular fracture.

Description

Inclusion Criteria:

  • written consent to participate in the study,
  • full legal age,
  • surgically treated hip acetabular fracture,
  • time after the surgery between 3 and 84 months,
  • full cognitive abilities, -full medical documentation, - the ability to fully load the operated limb (doctor's consent).

Exclusion Criteria:

  • craniocerebral injuries,
  • visual system disorders,
  • neurological disorders,
  • ear and sinuses infections,
  • spinal pain
  • injuries to the lower extremities,
  • chronic illnesses (cancer, Parkinson's disease, epilepsy, diabetes, neuro-muscular disorders, uncontrolled coronary heart disease),
  • taking psychoactive substances,
  • lower limb thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1- study group- patients after surgical treatment of acetabular fracture
1- study group- patients after surgical treatment of hip acetabular fracture

Static balance assessment on bi-module stabilometric platform CQStab2P. It registers the movement of centre of foot pressure (COP).

Harris hip score- disability assesment

Other Names:
  • harris hip score
2- control group- healthy subjects
2- control group- healthy subjects age, BMI matched

Static balance assessment on bi-module stabilometric platform CQStab2P. It registers the movement of centre of foot pressure (COP).

Harris hip score- disability assesment

Other Names:
  • harris hip score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static balance assessment with eyes open and closed
Time Frame: 2014-2017
Static balance parameters were analysed.
2014-2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: 2014-2017
Investigators determined patients' functional state on the basis of Harris Hip Score (HPP). This is an orthopedic tool which assesses functional state of patients after hip interventions. Harris hip score showed high validity and reliability. The tool assesses the following aspects: pain in the operated limb, hip movement range (registered with hand held goniometer), gait (limp, the distance a patient is able to walk, using mobility aids), other activities (walking the stairs, putting on shoes, and sitting, using public transport). Patients scored points for each analyzed element. The maximum number of points was 100. The score reflected the level of patient's functional state (a greater number of points meant that the patient had better ability). Then, we compared the results to the norms.
2014-2017
Merle d'aubigné score
Time Frame: 2014-2017
disability score
2014-2017
Body mass index
Time Frame: 2014-2017
Body weight and height will be collected
2014-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • Ds 310/SN4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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