Ulna FracturesDUL-ITSNCT05329012
Prospective Case Series to Assess Complications of Using Distal Ulna Locking Plate of I.T.S.
An observational study of Ulna Fractures, run by Medical University Innsbruck.
Trial summary
Background of the study: Various studies show that the outcome of unstable distal ulna fractures after open reduction and internal fixation is better than closed reduction. The previous plate system for the distal ulna fractures is applied exclusively on the extensor side. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulna Fractures
- What is being tested?
- DUL- Distal Ulna Locking PLate (I.T.S)
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2010to 30 Aug 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unstable distal ulna fractures who are over 18 years of age are included in this study. Patients should not have any additional pathology or previous damage to the distal radioulnar joint and should remain available for further examinations (e.g. no tourists, etc.).
Who may be able to join
- Age over 18 years
- unstable distal ulna fractures
- Fracture classification according to Biyani [4]: all types
Who cannot join
- Age under 18 years old
- stable fractures of the ulna
- Patient had one before ulna fracture
- Patient may result in physical or intellectual disability consent not grant
- Patient is for more Check-ups not available (Abroad)
- Patient does not have full legal capacity
- Alcohol and drug abuse
- Increased risk of anesthesia (from ASA 3)
About this study
Official title: Prospective Case Series to Assess the Handling, Healing and Complications of Using a Titanium Small Fragment Plating System With a New Shape Specifically Adapted to the Distal Ulna
Background of the study:
Various studies show that the outcome of unstable distal ulna fractures after open reduction and internal fixation is better than closed reduction. The previous plate system for the distal ulna fractures is applied exclusively on the extensor side. This often leads to irritation of the extensor tendons, as well as problems with pronation and supination. With the new shape of the angle-stable distal ulna plate, the investigator hopes that the stability of the fracture osteosynthesis will remain the same and that it will be better tolerated with regard to the surrounding soft tissue, especially the extensor tendons. In this way, an otherwise practically unavoidable removal of osteosynthesis material could - at least in some cases - be avoided and some patients spared a follow-up operation.
With this in mind, the investigator tries to achieve the greatest possible reconstruction and stability for early functional follow-up treatment with a slightly bulky implant placed in the tendon-free area.
Read the detailed description
With this study, the application and usability of the new angle-stable plate system should be determined and documented.
New value of the study:
This system enables an optimal position of the plate on the distal ulna, on the one hand due to the position on the flexor side and on the other hand due to the new shape, adapted to the anatomy of the distal ulna. The locking system using angle-stable screws corresponds to the systems previously used by I.T.S.
Design:
Prospectively, handling, advantages and possible complications of the angle-stable, distal ulna plate; Company I.T.S. in the osteosynthesis of the unstable distal ulna fracture. A total of 20 patients with unstable distal ulna fractures are to be treated and evaluated over a period of 12 months according to the study design.
Risk/Benefit:
With the use of the angle-stable distal ulna plate, company I.T.S. the patients broken bone may heal better. However, it is also possible that the patient will not benefit directly from his/her participation in this clinical trial. The Expected Benefit of the Locking Distal Ulnar Plate; Company I.T.S. includes:
- Reduced risk of bone misalignment after surgery.
- Less risk of irritating tendons on the plate with the new location.
- A removal of the osteosynthesis material could possibly be avoided.
- Conditions
- Ulna Fractures
- Being tested
- DUL- Distal Ulna Locking PLate (I.T.S)
- Medical subject headings
- Ulna Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DUL- Distal Ulna Locking PLate (I.T.S)Device
The patients are surgical treated with the Distal Ulna locking plate according to standard surgical procedures to treat the unstable distal ulna fractures.
| Study group | Role | What they receive |
|---|---|---|
| DUL treatment group | Patients with unstable ulna fractures will be operated and treated with the Distal Ulna locking plate (I.T.S. company) according to clinical routinal indication. Receives: Device: DUL- Distal Ulna Locking PLate (I.T.S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complicationsrate
Percentage of complications rate of patients treated with DUL
Measured: 1 year
Secondary outcomes (4)
Clinical outcome (range of motion)
Degree of the possible range of motion using a goniometer to measure the movement angles in correlation of the healing process. The better the range of motion the higher the value. Normally the following limits are given:
Radial: least 0 degree, maximum: 20 degree Ulnar: least 0 degree, maximum: 40 degree Extension: least 0 degree, maximum: 70 degree Flexion: least 0 degree, maximum: 70 degree Pronation: least 0 degree, maximum: 90 degree Supination: least 0 degree, maximum: 90 degree
Measured: 1year
Clinical outcome (grip strength wrist)
Extent of possible grip strength measurement using dynanometer in correlation of the healing process.
Minimum: 0 kilogram Maximum: 80 kg
Measured: 1year
Patient Reported Outcome (function)
Percentage of the patients with reduced or normal outcome after fractures using questionnaires like the DASH Score in correlation of the healing process. This is a score reporting the functional outcome, satisfaction and quality of life. Best score is 100%, least score 0%
Measured: 1 year
Patient Reported Outcome (pain)
Percentage of the patients with remaining pain after fracture using the visual analog scale in correlation of the healing process.
The scale reports about the intensity of pain. The maximum pain and least score is 10, and the best score is 0 which means "no pain".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Aug 2010
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
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 Ulna FracturesStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329012
- Sponsor's protocol ID
- DUL - ITS
- Acronym
- DUL-ITS
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stock K, Benedikt S, Kastenberger T, Kaiser P, Arora R, Zelger P, Pallua JD, Schmidle G. Outcomes of distal ulna locking plate in management of unstable distal ulna fractures: a prospective case series. Arch Orthop Trauma Surg. 2023 Jun;143(6):3137-3144. doi: 10.1007/s00402-022-04549-4. Epub 2022 Jul 18.
PubMed 35849186
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Series to Assess the Handling, Healing and Complications of Using a Titanium Small Fragment Plating System With a New Shape Specifically Adapted to the Distal Ulna
- ClinicalTrials.gov ID
- NCT05329012
- Acronym / sponsor ID
- DUL-ITS / DUL - ITS
- Conditions
- Ulna Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 14 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.
Background of the study:
Various studies show that the outcome of unstable distal ulna fractures after open reduction and internal fixation is better than closed reduction. The previous plate system for the distal ulna fractures is applied exclusively on the extensor side. This often leads to irritation of the extensor tendons, as well as problems with pronation and supination. With the new shape of the angle-stable distal ulna plate, the investigator hopes that the stability of the fracture osteosynthesis will remain the same and that it will be better tolerated with regard to the surrounding soft tissue, especially the extensor tendons. In this way, an otherwise practically unavoidable removal of osteosynthesis material could - at least in some cases - be avoided and some patients spared a follow-up operation.
With this in mind, the investigator tries to achieve the greatest possible reconstruction and stability for early functional follow-up treatment with a slightly bulky implant placed in the tendon-free area.
Detailed description
With this study, the application and usability of the new angle-stable plate system should be determined and documented.
New value of the study:
This system enables an optimal position of the plate on the distal ulna, on the one hand due to the position on the flexor side and on the other hand due to the new shape, adapted to the anatomy of the distal ulna. The locking system using angle-stable screws corresponds to the systems previously used by I.T.S.
Design:
Prospectively, handling, advantages and possible complications of the angle-stable, distal ulna plate; Company I.T.S. in the osteosynthesis of the unstable distal ulna fracture. A total of 20 patients with unstable distal ulna fractures are to be treated and evaluated over a period of 12 months according to the study design.
Risk/Benefit:
With the use of the angle-stable distal ulna plate, company I.T.S. the patients broken bone may heal better. However, it is also possible that the patient will not benefit directly from his/her participation in this clinical trial. The Expected Benefit of the Locking Distal Ulnar Plate; Company I.T.S. includes:
- Reduced risk of bone misalignment after surgery.
- Less risk of irritating tendons on the plate with the new location.
- A removal of the osteosynthesis material could possibly be avoided.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DUL treatment group | – | Device: DUL- Distal Ulna Locking PLate (I.T.S)Patients with unstable ulna fractures will be operated and treated with the Distal Ulna locking plate (I.T.S. company) according to clinical routinal indication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unstable distal ulna fractures who are over 18 years of age are included in this study. Patients should not have any additional pathology or previous damage to the distal radioulnar joint and should remain available for further examinations (e.g. no tourists, etc.).
Key inclusion criteria (3 listed)
- Age over 18 years
- unstable distal ulna fractures
- Fracture classification according to Biyani [4]: all types
Key exclusion criteria (8 listed)
- Age under 18 years old
- stable fractures of the ulna
- Patient had one before ulna fracture
- Patient may result in physical or intellectual disability consent not grant
- Patient is for more Check-ups not available (Abroad)
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 |
|---|---|---|
| DUL- Distal Ulna Locking PLate (I.T.S)The patients are surgical treated with the Distal Ulna locking plate according to standard surgical procedures to treat the unstable distal ulna fractures. | Device | DUL treatment group |
Primary outcome
Complicationsrate
Time frame: 1 year
Percentage of complications rate of patients treated with DUL
4 secondary outcomes
Clinical outcome (range of motion)
Time frame: 1year
Clinical outcome (grip strength wrist)
Time frame: 1year
Patient Reported Outcome (function)
Time frame: 1 year
Patient Reported Outcome (pain)
Time frame: 1 year
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 21 Sep 2022.
- Derived from this study: PubMed 35849186Stock K, Benedikt S, Kastenberger T, Kaiser P, Arora R, Zelger P, Pallua JD, Schmidle G. Outcomes of distal ulna locking plate in management of unstable distal ulna fractures: a prospective case series. Arch Orthop Trauma Surg. 2023 Jun;143(6):3137-3144. doi: 10.1007/s00402-022-04549-4. Epub 2022 Jul 18.
Related trials for Ulna Fractures
Active, not recruiting
Treatment of Olecranon Fractures in the Elderly
Olecranon Fracture
Recruiting
This is a Study to Find Out Whether Surgery Using a Metal Plate to Fix a Broken Elbow in Older Adults Leads to Better Recovery and Arm Function Compared to Non-surgical Treatment
Olecranon Fracture
Recruiting
The With Or Without Olecranon K-wires Trial
Olecranon Fracture
Recruiting
Evaluation of Dual Fixation of Distal Ulna Fractures by Flexible Intramedullary Nail and Mini Locked Plate 2.7 mm.
Distal Ulna Fracture
Not yet recruiting
Time to Healing in Displaced Pediatric Diaphyseal Forearm Fractures Treated With Bioabsorbable Compared to Titanium Intramedullary Nails
Forearm Injuries, Radius Fractures
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulna Fractures, run by Medical University Innsbruck.
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 8 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 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Complicationsrate (time frame: 1 year). 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 NCT05329012, 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 21 Sep 2022.