Monteggia's FractureNCT05325268
Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization
An observational study of Monteggia's Fracture, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Monteggia's Fracture
- What is being tested?
- Osteosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2018to 1 Feb 2019
- 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: Patients treated at the University Hospital Dresden.
Who may be able to join
- Patients with Monteggia fractures treated with osteosynthesis between 2012 and 2018
- understanding of German language (written and oral)
- informed consent
Who cannot join
- Patients not meeting the above criteria
Trial locations and contacts
1 site in 1 country.
About this study
Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.
Read the detailed description
A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.
In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score [DASH], MEPS [Mayo Elbow Performance Score], Oxford Elbow Score [OES], Pain, Subjective Elbow Score) and functionality (range of motion [ROM], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.
- Conditions
- Monteggia's Fracture
- Being tested
- Osteosynthesis
- Keywords
- elbow, fracture, patient reported outcome
- Medical subject headings
- Monteggia's Fracture, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Treatment of fracture with open reduction and osteosynthesis
| Study group | Role | What they receive |
|---|---|---|
| Monteggia Cohort | Including all Patients. Patients who had suffered a Monteggia fracture and were treated with osteosynthesis Receives: Procedure: Osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of Arm, Shoulder and Hand Score (DASH)
Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100
Measured: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Oxford Elbow Score (OES)
Evaluation of the subjective function (patient reported outcome) using the OES-Score, 0 - 48, best: 48, worst: 0
Measured: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Mayo Elbow Performance Score (MEPS)
Evaluation of the subjective function (patient reported outcome) using the MEPS-Score, 0-100, best: 100, worst: 0
Measured: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Range of Motion (ROM)
Objective functional clinical result. Evaluation of Motion of the Elbow in ° measured via goniometer. Physiological: Flexion/Extension 140/0/0°.
Measured: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Secondary outcomes (1)
Ulnar fracture localization (Radiologically)
Localization of ulnar fracture was measured from the proximal tip of the Olecranon to the fracture line on conventional X-ray in order to assess whether further distal fractures have a worse outcome compared to fractures with a close relation to or affecting the elbow joint [cm]
Measured: baseline (timepoint of injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Jun 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monteggia's FractureStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325268
- Sponsor's protocol ID
- Monteggia PROM
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. Data may be shared upon reasonable request.
Publications
Tille E, Seidel L, Schlussler A, Beyer F, Kasten P, Bota O, Biewener A, Nowotny J. Monteggia fractures: analysis of patient-reported outcome measurements in correlation with ulnar fracture localization. J Orthop Surg Res. 2022 Jun 7;17(1):303. doi: 10.1186/s13018-022-03195-1.
PubMed 35672754
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization
- ClinicalTrials.gov ID
- NCT05325268
- Acronym / sponsor ID
- Monteggia PROM
- Conditions
- Monteggia's Fracture
- Keywords
- elbow, fracture, patient reported outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 13 Apr 2022 (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.
Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.
Detailed description
A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.
In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score [DASH], MEPS [Mayo Elbow Performance Score], Oxford Elbow Score [OES], Pain, Subjective Elbow Score) and functionality (range of motion [ROM], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monteggia Cohort | – | Procedure: OsteosynthesisIncluding all Patients. Patients who had suffered a Monteggia fracture and were treated with osteosynthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated at the University Hospital Dresden.
Key inclusion criteria (3 listed)
- Patients with Monteggia fractures treated with osteosynthesis between 2012 and 2018
- understanding of German language (written and oral)
- informed consent
Key exclusion criteria (1 listed)
- Patients not meeting the above criteria
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 |
|---|---|---|
| OsteosynthesisTreatment of fracture with open reduction and osteosynthesis | Procedure or surgery | Monteggia Cohort |
Primary outcome
Disabilities of Arm, Shoulder and Hand Score (DASH)
Time frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Evaluation of the subjective function (patient reported outcome) using the DASH-Score, 0-100, best: 0, worst: 100
Oxford Elbow Score (OES)
Time frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Evaluation of the subjective function (patient reported outcome) using the OES-Score, 0 - 48, best: 48, worst: 0
Mayo Elbow Performance Score (MEPS)
Time frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Evaluation of the subjective function (patient reported outcome) using the MEPS-Score, 0-100, best: 100, worst: 0
Range of Motion (ROM)
Time frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Objective functional clinical result. Evaluation of Motion of the Elbow in ° measured via goniometer. Physiological: Flexion/Extension 140/0/0°.
1 secondary outcome
Ulnar fracture localization (Radiologically)
Time frame: baseline (timepoint of injury)
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 13 Apr 2022.
- Derived from this study: PubMed 35672754Tille E, Seidel L, Schlussler A, Beyer F, Kasten P, Bota O, Biewener A, Nowotny J. Monteggia fractures: analysis of patient-reported outcome measurements in correlation with ulnar fracture localization. J Orthop Surg Res. 2022 Jun 7;17(1):303. doi: 10.1186/s13018-022-03195-1.
- Individual participant dataSharing planned: No. No. Data may be shared upon reasonable request.
Related trials for Monteggia's Fracture
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Monteggia's Fracture, run by Technische Universität Dresden 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 3 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 13 Apr 2022. 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?
Disabilities of Arm, Shoulder and Hand Score (DASH) (time frame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05325268, which also lists 1 linked publication.
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 13 Apr 2022.