Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate (STIF)

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

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.

Study Overview

• Status: Completed
• Conditions: Wrist Arthritis; Wrist Osteoarthritis
• Intervention / Treatment: Procedure: Total wrist fusion

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

• Study Contact: Name: Marlène O'Donoghue; Phone Number: 00493081810201; Email: m.odonoghue@waldfriede.de

Study Locations

• Germany
  • Berlin, Germany, 14163
    • Waldfriede Hospital
    • Contact: Markus Bock, MD; Phone Number: 00493081810201; Email: m.bock@waldfriede.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals who have either suffered wrist destruction due to rheumatiod arthritis inflammation, or individuals who have received wrist fusion due to post-traumatic osteoarthritis.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid Arthritis wrist destruction; Patients with rheumatoid arthritis who received an APTUS wrist fusion system after 01.01.2014	Procedure: Total wrist fusion; 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	Procedure: Total wrist fusion; Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Waldfriede Hospital
• Investigators: Principal Investigator: Markus Bock, MD, Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin; Study Chair: Lautenbach Martin, MD, Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Actual): January 4, 2024
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: BB040/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No