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Clinical Trials/NCT06251349
NCT06251349
Completed
Not Applicable

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

University of Jena1 site in 1 country512 target enrollmentStarted: January 1, 2013Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
University of Jena
Enrollment
512
Locations
1
Primary Endpoint
Presence of heterotopic ossification (HO)

Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Intervention: 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

Intervention: Diclofenac (Drug)

Outcomes

Primary Outcomes

Presence of heterotopic ossification (HO)

Time Frame: at least 365 days postoperative

X-ray controlled HO diagnostics with the Brooker classification

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Jena
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Matthias Mäurer

Principal Investigator

University of Jena

Study Sites (1)

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