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Completed

NCT Number: NCT04902209

Static Balance Disorders in Patients After 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?

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

postural stability measurements

Procedure

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

Primary outcomes

  1. Static balance assessment with eyes open and closed

    Time frame: 2014-2017

    Static balance parameters were analysed.

Secondary outcomes

  1. 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.

  2. Merle d'aubigné score

    Time frame: 2014-2017

    disability score

  3. Body mass index

    Time frame: 2014-2017

    Body weight and height will be collected

Sponsors and collaborators

Lead sponsor

Józef Piłsudski University of Physical Education

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 26, 2021
Registry last updated
May 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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