Balance in Patients With Ectopic Bone Tissue After Total Hip Replacement

NCT05218954 | Completed

• 1 other identifier: WarsawMU/HO
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hip Osteoarthritis; Heterotopic Ossification; Hip Arthropathy

Keywords

total hip replacement; heterotopic ossification; hip arthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months postoperatively

Study Arms (2)

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

Biomechanical analysis of risk fall DIAGNOSTIC_TEST

Biomechanical analysis of risk fall in terms of balance

patients with heterotopic ossification; patients without heterotopic ossification

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, 03-984, Poland

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Ossification, Heterotopic

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Artur Stolarczyk, PhD, MD

  Department of Orthopedics and Rehabilitation, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Orthopedics and Rehabilitation

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: January 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: June 1, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

PL (1)