NCT05218954

Balance in Patients With Ectopic Bone Tissue After Total Hip Replacement

Completed Last updated 1 February 2022

What this trial tests

trial testing Biomechanical analysis of risk fall in Hip Osteoarthritis in 88 participants. Completed in 1 June 2021.

Timeline

1 January 2020

Primary endpoint
1 July 2020

1 June 2021

Quick facts

Lead sponsor	Medical University of Warsaw
Status	Completed
Study type	OBSERVATIONAL
Enrollment	88
Start date	1 January 2020
Primary completion	1 July 2020
Estimated completion	1 June 2021
Sites	1 location across Poland

Drugs / interventions tested

• Biomechanical analysis of risk fall

Conditions studied

• Hip Osteoarthritis — all drugs for Hip Osteoarthritis →
• Heterotopic Ossification — all drugs for Heterotopic Ossification →
• Hip Arthropathy — all drugs for Hip Arthropathy →

Sponsor

Medical University of Warsaw

Who can join

Adults 60 to 80, any sex, with Hip Osteoarthritis or Heterotopic Ossification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.