Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

NCT ID: NCT05875896

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-01-04

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.

Detailed Description

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Conditions

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Wrist Arthritis Wrist Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Rheumatoid Arthritis wrist destruction

Patients with rheumatoid arthritis who received an APTUS wrist fusion system after 01.01.2014

Total wrist fusion

Intervention Type PROCEDURE

Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

Osteoarthritis wrist destruction

Patients with post-traumatic wrist osteoarthritis who received an APTUS wrist fusion system after 01.01.2014

Total wrist fusion

Intervention Type PROCEDURE

Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

Interventions

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Total wrist fusion

Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Waldfriede Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lautenbach Martin, MD

Role: STUDY_CHAIR

Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Markus Bock, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Locations

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Waldfriede Hospital

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BB040/23

Identifier Type: -

Identifier Source: org_study_id

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