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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902209
• Other study ID #: Ds 310/SN4
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acetabular Fracture
• Balance; Distorted
• Disability Physical
• Fractures, Bone
• Hip Fractures

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