Heterotopic OssificationCONFIDENTIALNCT06251349
Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications
An observational study of Heterotopic Ossification and Hip Arthropathy, run by University of Jena at 1 site in Germany.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heterotopic Ossification, Hip Arthropathy, Myositis Ossificans Traumatica, Thigh
- What is being tested?
- Radiation and Diclofenac
- Type of treatment
- Surgery or procedure
- How many people
- 512 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2013to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with missing follow up image
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications in the Context of Total Hip Arthroplasty
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.
- Being tested
- Radiation, Diclofenac
- Keywords
- Heterotopic Ossification, Total Hip Arthroplasty, Irradiation Hip, Diclofenac, Prevention of HO, NSAID, Brooker Classification
- Medical subject headings
- Ossification, Heterotopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Single dose radiation with 7-8 Gy
DiclofenacDrug
Also called NSAID-Treatment
postoperative treatment with diclofenac to prevent HO
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of heterotopic ossification (HO)
X-ray controlled HO diagnostics with the Brooker classification
Measured: at least 365 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Jan 2013
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterotopic OssificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Mäurer, University of Jena
- Investigators
- Matthias Mäurer, Dr., Study director, Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251349
- Sponsor's protocol ID
- 2023-3175-Daten
- Acronym
- CONFIDENTIAL
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Radiotherapeutic and Medical Procedures for the Prophylaxis of Heterotopic Ossifications in the Context of Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06251349
- Acronym / sponsor ID
- CONFIDENTIAL / 2023-3175-Daten
- Keywords
- Heterotopic Ossification, Total Hip Arthroplasty, Irradiation Hip, Diclofenac, Prevention of HO, NSAID, Brooker Classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group with prophylactic irradiation | – | Radiation: RadiationPatients 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 | – | Drug: DiclofenacPatients with total hip arthroplasty and diclofenac treatment Quantity: 384 Period: 01.01.2013 - 31.12.2023 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with missing follow up image
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationSingle dose radiation with 7-8 Gy | Radiation | Intervention group with prophylactic irradiation |
| DiclofenacAlso: NSAID-Treatmentpostoperative treatment with diclofenac to prevent HO | Drug | Control group with prophylactic NSAID-treatment |
Primary outcome
Presence of heterotopic ossification (HO)
Time frame: at least 365 days postoperative
X-ray controlled HO diagnostics with the Brooker classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Mäurer, Dr. study director
Klinik für Strahlentherapie und Radioonkologie des Universitätsklinikums Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heterotopic Ossification and Hip Arthropathy, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of heterotopic ossification (HO) (time frame: at least 365 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.