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CompletedNCT06251349CONFIDENTIALUpdated Feb 9, 2024

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

An observational study in Heterotopic Ossification, Hip Arthropathy and Myositis Ossificans Traumatica, Thigh, sponsored by University of Jena. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by University of Jena · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
512
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Heterotopic Ossification
  • Hip Arthropathy
  • Myositis Ossificans Traumatica, Thigh

Keywords

  • Heterotopic Ossification
  • Total Hip Arthroplasty
  • Irradiation Hip
  • Diclofenac
  • Prevention of HO
  • NSAID
  • Brooker Classification
03

In context

Myositis

242 studies on the registry are indexed under Myositis; 103 are open to participants now.

This study's enrollment of 512 is above the median of 226 across 72 observational studies indexed under Myositis.

Browse Myositis studies →

Lead sponsor

University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All participants of the study are patients at the Universitätsklinikum Jena or the Waldkrankenhaus Eisenberg. Irradiation was performed in Jena. Total hip arthoplasty and following inpatient stay, inclusive NSAID therapy was performed in Eisenberg

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

Exclusion Criteria:

Patients with missing follow up image

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
512 participants (actual)
Patient registry
No

Groups and cohorts

  • Intervention group with prophylactic irradiation

    Patients with total hip arthroplasty and irradiation (preoperative on the day before the operation (\>24h preoperative)) Quantity: 128 Period: 01.01.2013 - 31.12.2023

    Radiation: Radiation

  • Control group with prophylactic NSAID-treatment

    Patients with total hip arthroplasty and diclofenac treatment Quantity: 384 Period: 01.01.2013 - 31.12.2023

    Drug: Diclofenac

Interventions

  • RadiationRadiation

    Single dose radiation with 7-8 Gy

  • DrugDiclofenac

    postoperative treatment with diclofenac to prevent HO

    Also known as: NSAID-Treatment

06

What researchers measure

Primary outcomes

  1. Presence of heterotopic ossification (HO)

    X-ray controlled HO diagnostics with the Brooker classification

    Time frame: at least 365 days postoperative

07

Study locations

1 site
  • Department of Radiooncology, Jena
    Jena, 07743, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06251349
Lead sponsor
University of Jena
Responsible party
Matthias Mäurer (Principal Investigator, University of Jena) — Principal investigator
First posted
Feb 9, 2024
Start date
Jan 1, 2013
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Feb 9, 2024

Study contacts

Matthias Mäurer, Dr.
study director · Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Jena

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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