Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05875896

Acronym

STIF

Enrollment

Registered

2023-05-25

Start date

2023-06-06

Completion date

2024-01-04

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wrist Arthritis, Wrist Osteoarthritis

Keywords

Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis

Brief summary

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.

Interventions

PROCEDURETotal wrist fusion

Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026