Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

Study Overview
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Brief Summary
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The primary working hypothesis of this study is whether wrist arthrodesis leads to an improvement in functional status in both rheumatoid arthritis and post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.

Official Title
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Investigation of the Functional Status After Wrist Arthrodesis (Medartis Aptus Model) in Patients With Rheumatoid Arthritis Compared to Patients With Post-traumatic Wrist Destruction

Conditions
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Wrist Arthritis, Wrist Osteoarthritis

Intervention / Treatment
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* Procedure: Total wrist fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-90 Wrist fusion took place between 2014 and 2022 using Aptus 2.5 TriLock Total Wrist Fusion Plate, Medartis at Hospital Waldfriede rheumatoid Arthritis post-traumatic osteoarthritis patterns: 1. scapholunate advanced collapse (SLAC) or 2. scaphoid nonunion advanced collapse (SNAC) Exclusion Criteria: post surgery bone fracture of the same limb Pregnancy, lactation active malignant tumor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid Arthritis wrist destruction<br>Patients with rheumatoid arthritis who received an APTUS wrist fusion system after 01.01.2014 | Procedure: Total wrist fusion<br>* Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate<br>|
| Osteoarthritis wrist destruction<br>Patients with post-traumatic wrist osteoarthritis who received an APTUS wrist fusion system after 01.01.2014 | Procedure: Total wrist fusion<br>* Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) | Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5) | all patients who underwent surgery between 2014 to 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Number of Participants with impaired wound healing, Re-surgery, Material loosening | all patients who underwent surgery between 2014 to 2022 | 
| Function | Grip force of the hand in Kg | all patients who underwent surgery between 2014 to 2022 | 
| Functional assessment: Goniometry | ROM of each joint of the hand with a goniometer. | all patients who underwent surgery between 2014 to 2022 | 
| Visual analogue scale (VAS) Pain | From 0mm (no pain) to 100mm (maximum pain imaginable) | all patients who underwent surgery between 2014 to 2022 | 
| Short-Form 36 (SF-36) | Scored review of health questionnaire SF36: minimum value = 0 ; maximum value = 100 | all patients who underwent surgery between 2014 to 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis