NCT04902209

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. 1.Do balance disorders occur in patients after ORIF of acetabular fractures?
  2. 2.Do surgical approach and fracture pattern influence balance level of patients?
  3. 3.Should therapy programs include certain stabilometric parameters adequate especially for this type of injury?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

2.4 years

First QC Date

May 21, 2021

Last Update Submit

May 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Static balance assessment with eyes open and closed

    Static balance parameters were analysed.

    2014-2017

Secondary Outcomes (3)

  • Harris hip score

    2014-2017

  • Merle d'aubigné score

    2014-2017

  • Body mass index

    2014-2017

Study Arms (2)

1- study group- patients after surgical treatment of acetabular fracture

1- study group- patients after surgical treatment of hip acetabular fracture

Procedure: postural stability measurements

2- control group- healthy subjects

2- control group- healthy subjects age, BMI matched

Procedure: postural stability measurements

Interventions

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

Also known as: harris hip score
1- study group- patients after surgical treatment of acetabular fracture2- control group- healthy subjects

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population involved 55 patients after surgical treatment of hip acetabular fracture.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 26660303BACKGROUND
  • 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.

    PMID: 16311194BACKGROUND
  • 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.

    PMID: 25058100BACKGROUND
  • 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.

    PMID: 25956896BACKGROUND
  • 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.

    PMID: 22884315BACKGROUND
  • 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2021

First Posted

May 26, 2021

Study Start

January 1, 2014

Primary Completion

June 1, 2016

Study Completion

January 1, 2017

Last Updated

May 26, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share