Wrist Arthritis Clinical Trial
— STIFOfficial title:
Investigation of the Functional Status After Wrist Arthrodesis (Medartis Aptus Model) in Patients With Rheumatoid Arthritis Compared to Patients With Post-traumatic Wrist Destruction
NCT number | NCT05875896 |
Other study ID # | BB040/23 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 6, 2023 |
Est. completion date | January 4, 2024 |
Verified date | January 2024 |
Source | Waldfriede Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | January 4, 2024 |
Est. primary completion date | January 4, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Waldfriede Hospital | Berlin |
Lead Sponsor | Collaborator |
---|---|
Waldfriede Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postoperative complications | Number of Participants with impaired wound healing, Re-surgery, Material loosening | all patients who underwent surgery between 2014 to 2022 | |
Secondary | Function | Grip force of the hand in Kg | all patients who underwent surgery between 2014 to 2022 | |
Secondary | Functional assessment: Goniometry | ROM of each joint of the hand with a goniometer. | all patients who underwent surgery between 2014 to 2022 | |
Secondary | Visual analogue scale (VAS) Pain | From 0mm (no pain) to 100mm (maximum pain imaginable) | all patients who underwent surgery between 2014 to 2022 | |
Secondary | 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 |
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