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

NCT06251349 | Completed

• 1 other identifier: 2023-3175-Daten
• Study Type: observational
• Target: 512
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heterotopic Ossification; Hip Arthropathy; Myositis Ossificans Traumatica, Thigh

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Presence of heterotopic ossification (HO)

  X-ray controlled HO diagnostics with the Brooker classification

  at least 365 days postoperative

Study Arms (2)

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

Radiation RADIATION

Single dose radiation with 7-8 Gy

Intervention group with prophylactic irradiation

Diclofenac DRUG

postoperative treatment with diclofenac to prevent HO

Also known as: NSAID-Treatment

Control group with prophylactic NSAID-treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with missing follow up image

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Department of Radiooncology, Jena

Jena, 07743, Germany

Location

MeSH Terms

Conditions

Ossification, Heterotopic

Interventions

Radiation; Diclofenac

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Phenomena; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Matthias Mäurer, Dr.

  Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Jena

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 9, 2024
• Study Start: January 1, 2013
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)