Hip FracturesNCT04902209
Static Balance Disorders in Patients After Surgical Treatment of Hip Acetabular Fractures
An observational study of Hip Fractures and Acetabular Fracture, run by Józef Piłsudski University of Physical Education.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Fractures, Acetabular Fracture, Balance; Distorted
- What is being tested?
- postural stability measurements
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population involved 55 patients after surgical treatment of hip acetabular fracture.
Who may be able to join
- 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).
Who cannot join
- craniocerebral injuries,
- visual system disorders,
- neurological disorders,
- ear and sinuses infections,
- spinal pain
- injuries to the lower extremities,
Show all 9Show fewer
- chronic illnesses (cancer, Parkinson's disease, epilepsy, diabetes, neuro-muscular disorders, uncontrolled coronary heart disease),
- taking psychoactive substances,
- lower limb thrombosis
About this study
Official title: 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?
Read the 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.
- Being tested
- postural stability measurements
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postural stability measurementsProcedure or surgery
Also called harris hip score
Static balance assessment on bi-module stabilometric platform CQStab2P. It registers the movement of centre of foot pressure (COP).
Harris hip score- disability assesment
| Study group | Role | What they receive |
|---|---|---|
| 1- study group- patients after surgical treatment of acetabular fracture | 1- study group- patients after surgical treatment of hip acetabular fracture Receives: Procedure: postural stability measurements | |
| 2- control group- healthy subjects | 2- control group- healthy subjects age, BMI matched Receives: Procedure: postural stability measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static balance assessment with eyes open and closed
Static balance parameters were analysed.
Measured: 2014-2017
Secondary outcomes (3)
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.
Measured: 2014-2017
Merle d'aubigné score
disability score
Measured: 2014-2017
Body mass index
Body weight and height will be collected
Measured: 2014-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study startJan 2014
- Primary completionJun 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902209
- Sponsor's protocol ID
- Ds 310/SN4
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 26 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26660303Arokoski 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.
PubMed 16311194Bhat 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.
PubMed 25058100Baschera 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.
PubMed 25956896Edgren 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.
PubMed 22884315Dadura 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.
PubMed 35162298
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static Balance Disorders in Patients After ( (ORIF) Surgical Treatment of Hip Acetabular Fractures
- ClinicalTrials.gov ID
- NCT04902209
- Acronym / sponsor ID
- Ds 310/SN4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1- study group- patients after surgical treatment of acetabular fracture | – | Procedure: postural stability measurements1- study group- patients after surgical treatment of hip acetabular fracture |
| 2- control group- healthy subjects | – | Procedure: postural stability measurements2- control group- healthy subjects age, BMI matched |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population involved 55 patients after surgical treatment of hip acetabular fracture.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- craniocerebral injuries,
- visual system disorders,
- neurological disorders,
- ear and sinuses infections,
- spinal pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| postural stability measurementsAlso: harris hip scoreStatic balance assessment on bi-module stabilometric platform CQStab2P. It registers the movement of centre of foot pressure (COP). Harris hip score- disability assesment | Procedure or surgery | 1- study group- patients after surgical treatment of acetabular fracture, 2- control group- healthy subjects |
Primary outcome
Static balance assessment with eyes open and closed
Time frame: 2014-2017
Static balance parameters were analysed.
3 secondary outcomes
Harris hip score
Time frame: 2014-2017
Merle d'aubigné score
Time frame: 2014-2017
Body mass index
Time frame: 2014-2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Background: PubMed 26660303Aprato 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.
- Background: PubMed 16311194Arokoski 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.
- Background: PubMed 25058100Bhat 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.
- Background: PubMed 25956896Baschera 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.
- Background: PubMed 22884315Edgren 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.
- Derived from this study: PubMed 35162298Dadura 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Acetabular Fracture, run by Józef Piłsudski University of Physical Education.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static balance assessment with eyes open and closed (time frame: 2014-2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04902209, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.