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

NCT ID: NCT06251349

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

512 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heterotopic Ossification Hip Arthropathy Myositis Ossificans Traumatica, Thigh

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type RADIATION

Single dose radiation with 7-8 Gy

Control group with prophylactic NSAID-treatment

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

Diclofenac

Intervention Type DRUG

postoperative treatment with diclofenac to prevent HO

Interventions

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Radiation

Single dose radiation with 7-8 Gy

Intervention Type RADIATION

Diclofenac

postoperative treatment with diclofenac to prevent HO

Intervention Type DRUG

Other Intervention Names

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NSAID-Treatment

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Matthias Mäurer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias Mäurer, Dr.

Role: STUDY_DIRECTOR

Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Jena

Locations

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Department of Radiooncology, Jena

Jena, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2023-3175-Daten

Identifier Type: -

Identifier Source: org_study_id

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