Prospective Case Series to Assess Complications of Using Distal Ulna Locking Plate of I.T.S.

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

Sponsors

Lead Sponsor: Medical University Innsbruck

Source Medical University Innsbruck
Brief 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. 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.

Overall Status Completed
Start Date 2010-08-01
Completion Date 2016-08-30
Primary Completion Date 2016-08-30
Study Type Observational
Primary Outcome
Measure Time Frame
Complicationsrate 1 year
Secondary Outcome
Measure Time Frame
Clinical outcome (range of motion) 1year
Clinical outcome (grip strength wrist) 1year
Patient Reported Outcome (function) 1 year
Patient Reported Outcome (pain) 1 year
Enrollment 22
Condition
Intervention

Intervention Type: Device

Intervention Name: DUL- Distal Ulna Locking PLate (I.T.S)

Description: The patients are surgical treated with the Distal Ulna locking plate according to standard surgical procedures to treat the unstable distal ulna fractures.

Arm Group Label: DUL treatment group

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2022-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: DUL treatment group

Description: 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.

Acronym DUL-ITS
Study Design Info

Observational Model: Case-Only

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulna Fractures

Clinical Trials on DUL- Distal Ulna Locking PLate (I.T.S)