- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04902209
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
- Do balance disorders occur in patients after ORIF of acetabular fractures?
- Do surgical approach and fracture pattern influence balance level of patients?
- Should therapy programs include certain stabilometric parameters adequate especially for this type of injury?
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
|
|
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:
|
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
Publications and helpful links
General Publications
- Edgren J, Salpakoski A, Rantanen T, Heinonen A, Kallinen M, von Bonsdorff MB, Portegijs E, Sihvonen S, Sipila S. Balance confidence and functional balance are associated with physical disability after hip fracture. Gait Posture. 2013 Feb;37(2):201-5. doi: 10.1016/j.gaitpost.2012.07.001. Epub 2012 Aug 9.
- Aprato A, Joeris A, Tosto F, Kalampoki V, Stucchi A, Massè A. Direct and indirect costs of surgically treated pelvic fractures. Arch Orthop Trauma Surg. 2016 Mar;136(3):325-30. doi: 10.1007/s00402-015-2373-9. Epub 2015 Dec 11.
- Arokoski JP, Leinonen V, Arokoski MH, Aalto H, Valtonen H. Postural control in male patients with hip osteoarthritis. Gait Posture. 2006 Jan;23(1):45-50. Epub 2005 Jan 18.
- Bhat NA, Kangoo KA, Wani IH, Wali GR, Muzaffar N, Dar RA. Operative management of displaced acetabular fractures: an institutional experience with a midterm follow-up. Ortop Traumatol Rehabil. 2014 May-Jun;16(3):245-52. doi: 10.5604/15093492.1112281.
- Baschera D, Rad H, Collopy D, Zellweger R. Incidence and clinical relevance of heterotopic ossification after internal fixation of acetabular fractures: retrospective cohort and case control study. J Orthop Surg Res. 2015 May 9;10:60. doi: 10.1186/s13018-015-0202-z.
- Dadura E, Truszczynska-Baszak A, Szydlowski D. Radiological and Functional Assessment of Treatment Outcomes in Patients after Open Reduction with Internal Fixation (ORIF) of Acetabular Fractures. Int J Environ Res Public Health. 2022 Jan 24;19(3):1277. doi: 10.3390/ijerph19031277.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ds 310/SN4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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