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

Completed

• Conditions: Hip Arthropathy; Heterotopic Ossification; Myositis Ossificans Traumatica, Thigh
• Interventions: Radiation: Radiation; Drug: Diclofenac

• Registration Number: NCT06251349
• Lead Sponsor: University of Jena

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.

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-01-22
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 512

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention group with prophylactic irradiation	Radiation	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
Control group with prophylactic NSAID-treatment	Diclofenac	Patients with total hip arthroplasty and diclofenac treatment Quantity: 384 Period: 01.01.2013 - 31.12.2023

Primary Outcome Measures

Name	Time	Method
Presence of heterotopic ossification (HO)	at least 365 days postoperative	X-ray controlled HO diagnostics with the Brooker classification

Trial Locations

Locations (1)

Department of Radiooncology, Jena; 🇩🇪 Jena, Germany