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

NCT05329012 | Completed

• 1 other identifier: DUL - ITS
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ulna Fractures

Outcome Measures

Primary Outcomes (1)

• Complicationsrate

  Percentage of complications rate of patients treated with DUL

  1 year

Secondary Outcomes (4)

• Clinical outcome (range of motion)

  1year

• Clinical outcome (grip strength wrist)

  1year

• Patient Reported Outcome (function)

  1 year

• Patient Reported Outcome (pain)

  1 year

Study Arms (1)

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.

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

Interventions

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.

DUL treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.).

You may qualify if:

• Age over 18 years
• unstable distal ulna fractures
• Fracture classification according to Biyani \[4\]: all types

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Related Publications (1)

• 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.

  PMID: 35849186 DERIVED

MeSH Terms

Conditions

Ulna Fractures

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: August 1, 2010
• Primary Completion: August 30, 2016
• Study Completion: August 30, 2016
• Last Updated: September 21, 2022

Record last verified: 2022-04