Clinical trial NCT04902209: Static Balance Disorders in Patients After Surgical Treatment of Hip Acetabular Fractures
Official title: Static Balance Disorders in Patients After ( (ORIF) Surgical Treatment of Hip Acetabular Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Acetabular Fracture
Balance; Distorted
Disability Physical
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population involved 55 patients after surgical treatment of hip acetabular fracture.

Brief summary: 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Static balance assessment with eyes open and closed
timeFrame: 2014-2017
Secondary outcomes:
measure: Harris hip score
timeFrame: 2014-2017
measure: Merle d'aubigné score
timeFrame: 2014-2017
measure: Body mass index
timeFrame: 2014-2017
Other outcomes:
Locations:
Study officials:
References:
citation: Aprato A, Joeris A, Tosto F, Kalampoki V, Stucchi A, Masse 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.
citation: 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. doi: 10.1016/j.gaitpost.2004.11.017. Epub 2005 Jan 18.
citation: 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.
citation: 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.
citation: 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.
citation: 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.