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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04902209
Other study ID # Ds 310/SN4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date January 2017

Study information

Verified date May 2021
Source Józef Pilsudski University of Physical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date January 2017
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Intervention

Procedure:
postural stability measurements
Static balance assessment on bi-module stabilometric platform CQStab2P. It registers the movement of centre of foot pressure (COP). Harris hip score- disability assesment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Józef Pilsudski University of Physical Education

References & Publications (5)

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. — View 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. Epub 2005 Jan 18. — View 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. — View 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. — View Citation

Edgren J, Salpakoski A, Rantanen T, Heinonen A, Kallinen M, von Bonsdorff MB, Portegijs E, Sihvonen S, Sipilä 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Static balance assessment with eyes open and closed Static balance parameters were analysed. 2014-2017
Secondary Harris hip score 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
Secondary Merle d'aubigné score disability score 2014-2017
Secondary Body mass index Body weight and height will be collected 2014-2017
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