Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications

Aim of this study is to proof the efficacy of in Jena established prophylaxis of new bone formation aside the skeleton with irradiation and compare it with the common literature. Furthermore we want to compare irradiation treatment with the alternative prophylaxis with analgetics from the NSAID type.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heterotopic Ossification Hip Arthropathy Myositis Ossificans Traumatica, Thigh Ossification, Heterotopic Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Radiooncology, Jena

Jena, 07743, Germany

About this study

Aim of this retrospective analysis is to compare the incidence of heterotopic ossification one year after total hip arthroplasty with the at our location established concept of irradiation 24h preoperative and incidence in common literature. Furthermore the comparison between irradiated patients and patients treated with NSAIDs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with total hip arthroplasty performed at Eisenberg Patients with preoperative irradiation (24h pre-op) or postoperative diclofenac treatment Patients with x-ray images immediately (3-5 days postoperative) postoperative and at least 365 days postoperative

Exclusion criteria

Patients with missing follow up image

Treatment and study plan

Radiation

Single dose radiation with 7-8 Gy

Diclofenac

Drug

postoperative treatment with diclofenac to prevent HO

Other names: NSAID-Treatment

Primary outcomes

Presence of heterotopic ossification (HO)

Time frame: at least 365 days postoperative

X-ray controlled HO diagnostics with the Brooker classification

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Registry information

Official study title

Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications in the Context of Total Hip Arthroplasty

Acronym: CONFIDENTIAL

Important dates

Study start: 2013
Primary completion: 2023
Study completion: 2023
First posted: Feb 9, 2024
Registry last updated: Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed