Hip OsteoarthritisNCT05218954
Balance in Patients With Ectopic Bone Tissue After Total Hip Replacement
An observational study of Hip Osteoarthritis and Heterotopic Ossification, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
One of the typical complications which occurs after total hip replacement (THR) procedure is heterotopic ossification (HO). According to current studies abnormal formation of bone after trauma or replacement of the hip could reach even 90% of cases. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Hip Osteoarthritis, Heterotopic Ossification, Hip Arthropathy
- What is being tested?
- Biomechanical analysis of risk fall
- How many people
- 88 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 1 Jun 2021
- 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 60 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing total hip replacement, who developed heterotopic ossification during 6 months postoperatively.
Who may be able to join
- age between 60 and 80 years
- consent to particiapte in the study
- unilateral hip osteoarthritis
- primary hip osteoarthritis
Who cannot join
- neurological disorders
- diabetes mellitus
- any other surgery or lower limb injury during follow-up
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, 03-984
About this study
Official title: Posture Stability and Risk Fall Test in Objective Assessment of Balance in Patients With Ectopic Bone Tissue After Total Hip Replacement
One of the typical complications which occurs after total hip replacement (THR) procedure is heterotopic ossification (HO). According to current studies abnormal formation of bone after trauma or replacement of the hip could reach even 90% of cases. Heterotopic ossifications are causing the following symptoms, such as: pain, swelling, erythema and warmth along with joint immobility. Those factors could have an impact on maintaining the posture, especially in patients after THR.
It is well known since the 90s that the risk of fall among the population older than 65 is high. Data shows that over 30% of those people have such an incident at least once in a year. Majority of them do not have further consequences, however about 10% result in serious trauma to the head and musculoskeletal system. Falls of people who underwent THR are sometimes connected with periprosthetic fractures, which treatment is much more complicated and is associated with a higher risk of failure than treatment of ordinary fractures of the lower limb. What may even worsen the situation is that elderly people very often suffer from many diseases including osteoporosis or neoplasm which increase the risk of fracture. The rate of falls is even higher among patients hospitalised from hip fractures. In the first month after returning home about 14% of patients fall. During the 6 month period after hospitalisation it reaches 53%. So far, the influence of heterotopic ossifications on the risk of falls is unknown in the literature.
Read the detailed description
This study was conducted according to the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) and an appropriate checklist was presented to the editors of the Journal. Study protocol was designed as a retrospective matched-cohort observational study. This study was approved by Institutional Bioethics Committee (Number: KB/102/2007) Between January 2020 and December 2020 312 patients undergoing total hip replacement were observed. During the standard 6-weeks, 3-months and 6-months follow-up visit every patient had an AP pelvic weight-bearing x-ray. All patients were qualified and operated by a fellowship-trained single surgeon. For the present analysis, the following demographic patient data were queried: sex, age at surgery (years), and BMI. 49 patients, who developed ectopic bone formation were observed. For these patients, a propensity score based on age, sex and BMI was generated. Patients with HO were matched to patients without HO patients using a 0.1 propensity score threshold with priority given to exact matches.
All patients were operated through an anterolateral approach with the patient lying on the healthy side with one-third medium gluteal muscle dissection. Uncemented Taperloc/Allofit total hip implants (Zimmer Biomet, Warsaw, IN, USA) were used in every single case. Femoral neck dissection was performed after full joint dislocation, between the tip of the greater trochanter to the point 10 mm proximal to the lesser trochanter. Acetabular cup was placed aiming 30-40 degrees of acetabular cup inclination and 10 degrees of anteversion. Femoral stem was aimed to be placed in the anatomical axis of the femur. The postoperative protocol included chemical and mechanical thromboprophylaxis unless specifically contraindicated. All patients received one dose of parenteral antibiotics at the induction of anaesthesia and two further doses post-operatively. No pre- or postoperative ectopic bone formation prophylaxis was performed. Flexion and extension exercises of the hip, knee and ankle and isometric quadriceps contraction exercises were started on the first postoperative day, with full weight-bearing as tolerated. The aim of mobilisation with a physiotherapist was to obtain flexion of the hip of 90° mobilising and safely walking with crutches by the third postoperative day.
At 6-months follow-up visit, radiographs analysis in terms of any ectopic bone formation was performed using Brooker's classification.
All patients fulfilled WOMAC (The Western Ontario and McMaster Universities Arthritis Index) and Oxford questionnaires preoperatively and during follow-up visits.
Both cohorts underwent biomechanical assessment, performed by two independent blinded researchers (PC, KŻ) who were not aware whether patients developed ectopic bone following total hip replacement. Every analysis was performed using the Biodex Balance System (Biodex, Inc, Shirley, NY) with participants both feet standing steadily on the platform. Every participant was protected from falling with the use of support. Device screen was installed at the level of the patient's sight to avoid taking an uncomfortable position that might have influenced the results.
Postural stability test was performed, containing the results from three measurements. Every measurement has been performed on the 12th level of the platform stability for 20 seconds with 10 seconds break between every test. Results obtained from the participants were recorded as stability index (SI) values which represent deviations of platform position from the vertical in degrees. The higher SI values are, the more difficult it was for participants to maintain stability during the test.
Risk of fall test - a single test consisted of the results obtained from three measurements. Each measurement was performed at level 6 of the platform stability for 20 seconds with a 10-second rest time between attempts. The person conducting the test informed the patient in advance of how the test would proceed and then gave verbal instructions during each test. The patients were positioned in the centre of the platform, both feet set with their feet shoulder-width apart. The final result of each test was a computerised risk of fall assessment report with patient scores related to normative data.
- Being tested
- Biomechanical analysis of risk fall
- Keywords
- total hip replacement, heterotopic ossification, hip arthritis
- Medical subject headings
- Osteoarthritis, Hip, Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomechanical analysis of risk fallDiagnostic test
Biomechanical analysis of risk fall in terms of balance
| Study group | Role | What they receive |
|---|---|---|
| patients with heterotopic ossification | patients with heterotopic ossification following THR Receives: Diagnostic Test: Biomechanical analysis of risk fall | |
| patients without heterotopic ossification | patients without heterotopic ossification following THR Receives: Diagnostic Test: Biomechanical analysis of risk fall |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability test
Results obtained from the participants were recorded as stability index (SI) values which represent deviations of platform position from the vertical in degrees. The higher SI values are, the more difficult it was for participants to maintain stability during the test.
Measured: 6 months postoperatively
Risk of fall test
a single test consisted of the results obtained from three measurements. Each measurement was performed at level 6 of the platform stability for 20 seconds with a 10-second rest time between attempts. The person conducting the test informed the patient in advance of how the test would proceed and then gave verbal instructions during each test. The patients were positioned in the centre of the platform, both feet set with their feet shoulder-width apart. The final result of each test was a computerised risk of fall assessment report with patient scores related to normative data.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jan 2020
- Primary completion1 Jul 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
- Investigators
- Artur Stolarczyk, PhD, MD, Principal investigator, Department of Orthopedics and Rehabilitation, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218954
- Sponsor's protocol ID
- WarsawMU/HO
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after rationale request from the researcher.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posture Stability and Risk Fall Test in Objective Assessment of Balance in Patients With Ectopic Bone Tissue After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT05218954
- Acronym / sponsor ID
- WarsawMU/HO
- Keywords
- total hip replacement, heterotopic ossification, hip arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 1 Feb 2022 (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.
One of the typical complications which occurs after total hip replacement (THR) procedure is heterotopic ossification (HO). According to current studies abnormal formation of bone after trauma or replacement of the hip could reach even 90% of cases. Heterotopic ossifications are causing the following symptoms, such as: pain, swelling, erythema and warmth along with joint immobility. Those factors could have an impact on maintaining the posture, especially in patients after THR.
It is well known since the 90s that the risk of fall among the population older than 65 is high. Data shows that over 30% of those people have such an incident at least once in a year. Majority of them do not have further consequences, however about 10% result in serious trauma to the head and musculoskeletal system. Falls of people who underwent THR are sometimes connected with periprosthetic fractures, which treatment is much more complicated and is associated with a higher risk of failure than treatment of ordinary fractures of the lower limb. What may even worsen the situation is that elderly people very often suffer from many diseases including osteoporosis or neoplasm which increase the risk of fracture. The rate of falls is even higher among patients hospitalised from hip fractures. In the first month after returning home about 14% of patients fall. During the 6 month period after hospitalisation it reaches 53%. So far, the influence of heterotopic ossifications on the risk of falls is unknown in the literature.
Detailed description
This study was conducted according to the STROBE (Strengthening the Reporting of Observational studies in Epidemiology) and an appropriate checklist was presented to the editors of the Journal. Study protocol was designed as a retrospective matched-cohort observational study. This study was approved by Institutional Bioethics Committee (Number: KB/102/2007) Between January 2020 and December 2020 312 patients undergoing total hip replacement were observed. During the standard 6-weeks, 3-months and 6-months follow-up visit every patient had an AP pelvic weight-bearing x-ray. All patients were qualified and operated by a fellowship-trained single surgeon. For the present analysis, the following demographic patient data were queried: sex, age at surgery (years), and BMI. 49 patients, who developed ectopic bone formation were observed. For these patients, a propensity score based on age, sex and BMI was generated. Patients with HO were matched to patients without HO patients using a 0.1 propensity score threshold with priority given to exact matches.
All patients were operated through an anterolateral approach with the patient lying on the healthy side with one-third medium gluteal muscle dissection. Uncemented Taperloc/Allofit total hip implants (Zimmer Biomet, Warsaw, IN, USA) were used in every single case. Femoral neck dissection was performed after full joint dislocation, between the tip of the greater trochanter to the point 10 mm proximal to the lesser trochanter. Acetabular cup was placed aiming 30-40 degrees of acetabular cup inclination and 10 degrees of anteversion. Femoral stem was aimed to be placed in the anatomical axis of the femur. The postoperative protocol included chemical and mechanical thromboprophylaxis unless specifically contraindicated. All patients received one dose of parenteral antibiotics at the induction of anaesthesia and two further doses post-operatively. No pre- or postoperative ectopic bone formation prophylaxis was performed. Flexion and extension exercises of the hip, knee and ankle and isometric quadriceps contraction exercises were started on the first postoperative day, with full weight-bearing as tolerated. The aim of mobilisation with a physiotherapist was to obtain flexion of the hip of 90° mobilising and safely walking with crutches by the third postoperative day.
At 6-months follow-up visit, radiographs analysis in terms of any ectopic bone formation was performed using Brooker's classification.
All patients fulfilled WOMAC (The Western Ontario and McMaster Universities Arthritis Index) and Oxford questionnaires preoperatively and during follow-up visits.
Both cohorts underwent biomechanical assessment, performed by two independent blinded researchers (PC, KŻ) who were not aware whether patients developed ectopic bone following total hip replacement. Every analysis was performed using the Biodex Balance System (Biodex, Inc, Shirley, NY) with participants both feet standing steadily on the platform. Every participant was protected from falling with the use of support. Device screen was installed at the level of the patient's sight to avoid taking an uncomfortable position that might have influenced the results.
Postural stability test was performed, containing the results from three measurements. Every measurement has been performed on the 12th level of the platform stability for 20 seconds with 10 seconds break between every test. Results obtained from the participants were recorded as stability index (SI) values which represent deviations of platform position from the vertical in degrees. The higher SI values are, the more difficult it was for participants to maintain stability during the test.
Risk of fall test - a single test consisted of the results obtained from three measurements. Each measurement was performed at level 6 of the platform stability for 20 seconds with a 10-second rest time between attempts. The person conducting the test informed the patient in advance of how the test would proceed and then gave verbal instructions during each test. The patients were positioned in the centre of the platform, both feet set with their feet shoulder-width apart. The final result of each test was a computerised risk of fall assessment report with patient scores related to normative data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with heterotopic ossification | – | Diagnostic Test: Biomechanical analysis of risk fallpatients with heterotopic ossification following THR |
| patients without heterotopic ossification | – | Diagnostic Test: Biomechanical analysis of risk fallpatients without heterotopic ossification following THR |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total hip replacement, who developed heterotopic ossification during 6 months postoperatively.
Key inclusion criteria (4 listed)
- age between 60 and 80 years
- consent to particiapte in the study
- unilateral hip osteoarthritis
- primary hip osteoarthritis
Key exclusion criteria (3 listed)
- neurological disorders
- diabetes mellitus
- any other surgery or lower limb injury during follow-up
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 |
|---|---|---|
| Biomechanical analysis of risk fallBiomechanical analysis of risk fall in terms of balance | Diagnostic test | patients with heterotopic ossification, patients without heterotopic ossification |
Primary outcome
Postural stability test
Time frame: 6 months postoperatively
Results obtained from the participants were recorded as stability index (SI) values which represent deviations of platform position from the vertical in degrees. The higher SI values are, the more difficult it was for participants to maintain stability during the test.
Risk of fall test
Time frame: 6 months postoperatively
a single test consisted of the results obtained from three measurements. Each measurement was performed at level 6 of the platform stability for 20 seconds with a 10-second rest time between attempts. The person conducting the test informed the patient in advance of how the test would proceed and then gave verbal instructions during each test. The patients were positioned in the centre of the platform, both feet set with their feet shoulder-width apart. The final result of each test was a computerised risk of fall assessment report with patient scores related to normative data.
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 1 Feb 2022.
- Individual participant dataSharing planned: Yes. IPD will be shared after rationale request from the researcher.
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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.
Artur Stolarczyk, PhD, MD principal investigator
Department of Orthopedics and Rehabilitation, Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Heterotopic Ossification, run by Medical University of Warsaw at 1 site in Poland.
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 4 inclusion and 3 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 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Postural stability test (time frame: 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2022; AzTrials last refreshed its copy on 3 Nov 2026.