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NCT06251349 Clinical Trial

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

Hip Arthropathy Clinical Trial

— CONFIDENTIAL  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06251349
Other study ID # 2023-3175-Daten
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2013
Est. completion date December 31, 2023

Study information
Verified date February 2024
Source University of Jena
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 512
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Radiation
Single dose radiation with 7-8 Gy
Drug:
• Diclofenac
postoperative treatment with diclofenac to prevent HO

Locations
Country Name City State
Germany Department of Radiooncology, Jena Jena

Sponsors (1)
Lead Sponsor Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Presence of heterotopic ossification (HO) X-ray controlled HO diagnostics with the Brooker classification at least 365 days postoperative
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