Prospective Case Series to Assess Complications of Using Distal Ulna Locking Plate of I.T.S. (DUL-ITS)

September 16, 2022 updated by: Medical University Innsbruck

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.

Study Overview




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.


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.


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 Type


Enrollment (Actual)


Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers


Genders Eligible for Study


Sampling Method

Non-Probability Sample

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.).


Inclusion Criteria:

  1. Age over 18 years
  2. unstable distal ulna fractures

Fracture classification according to Biyani [4]: all types

Exclusion Criteria:

  1. Age under 18 years old
  2. stable fractures of the ulna
  3. Patient had one before ulna fracture
  4. Patient may result in physical or intellectual disability consent not grant
  5. Patient is for more Check-ups not available (Abroad)
  6. Patient does not have full legal capacity
  7. Alcohol and drug abuse
  8. Increased risk of anesthesia (from ASA 3)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
The patients are surgical treated with the Distal Ulna locking plate according to standard surgical procedures to treat the unstable distal ulna fractures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Frame: 1 year
Percentage of complications rate of patients treated with DUL
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome (range of motion)
Time Frame: 1year

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

Clinical outcome (grip strength wrist)
Time Frame: 1year

Extent of possible grip strength measurement using dynanometer in correlation of the healing process.

Minimum: 0 kilogram Maximum: 80 kg

Patient Reported Outcome (function)
Time Frame: 1 year
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%
1 year
Patient Reported Outcome (pain)
Time Frame: 1 year

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".

1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2010

Primary Completion (ACTUAL)

August 30, 2016

Study Completion (ACTUAL)

August 30, 2016

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (ACTUAL)

April 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DUL - ITS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product


Studies a U.S. FDA-regulated device product


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Clinical Trials on Ulna Fractures