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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complicationsrate | Percentage of complications rate of patients treated with DUL | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Fracture classification according to Biyani [4]: all types
Exclusion Criteria:
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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.).
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35849186 | Derived | 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. |
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| ID | Term |
|---|---|
| D014458 | Ulna Fractures |
| ID | Term |
|---|---|
| D005543 | Forearm Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| 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 | 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% | 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". | 1 year |