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CompletedNCT05218954Updated Feb 1, 2022

Balance in Patients With Ectopic Bone Tissue After Total Hip Replacement

An observational study in Hip Osteoarthritis, Heterotopic Ossification and Hip Arthropathy, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by Medical University of Warsaw · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
88
Ages
60 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hip Osteoarthritis
  • Heterotopic Ossification
  • Hip Arthropathy

Keywords

  • total hip replacement
  • heterotopic ossification
  • hip arthritis
03

In context

Osteoarthritis, Hip

642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.

This study's enrollment of 88 is below the median of 135 across 159 observational studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients undergoing total hip replacement, who developed heterotopic ossification during 6 months postoperatively.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age between 60 and 80 years
  • consent to particiapte in the study
  • unilateral hip osteoarthritis
  • primary hip osteoarthritis

Exclusion criteria

Exclusion Criteria:

  • neurological disorders
  • diabetes mellitus
  • any other surgery or lower limb injury during follow-up
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
88 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with heterotopic ossification

    patients with heterotopic ossification following THR

    Diagnostic Test: Biomechanical analysis of risk fall

  • patients without heterotopic ossification

    patients without heterotopic ossification following THR

    Diagnostic Test: Biomechanical analysis of risk fall

Interventions

  • Diagnostic testBiomechanical analysis of risk fall

    Biomechanical analysis of risk fall in terms of balance

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months postoperatively

  2. 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.

    Time frame: 6 months postoperatively

07

Study locations

1 site
  • Department of Othopedics and Rehabilitation, Medical University of Warsaw
    Warsaw, 03-984, Poland
08

References and documents

Individual participant data

Plan to share: Yes — IPD will be shared after rationale request from the researcher.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2020 to primary completion in Jul 2020, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2022
First posted
Feb 1, 2022
StartActual
Jan 1, 2020
Primary completionActual
Jul 1, 2020
CompletionActual
Jun 1, 2021
Last update
Feb 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05218954
Responsible party
Artur Stolarczyk (Head of the Department of Orthopedics and Rehabilitation, Medical University of Warsaw) — Principal investigator
First posted
Feb 1, 2022
Start date
Jan 1, 2020
Primary completion
Jul 1, 2020
Completion
Jun 1, 2021
Last update
Feb 1, 2022

Study contacts

Artur Stolarczyk, PhD, MD
principal investigator · Department of Orthopedics and Rehabilitation, Medical University of Warsaw

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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