Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

Completed

• Conditions: Wrist Arthritis; Wrist Osteoarthritis
• Interventions: Procedure: Total wrist fusion

• Registration Number: NCT05875896
• Lead Sponsor: Waldfriede Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-05-25
• Study Start: 2023-06-06
• Status Verified: 2024-01
• Primary Completion: 2024-01-04
• Study Completion: 2024-01-04
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Osteoarthritis wrist destruction	Total wrist fusion	Patients with post-traumatic wrist osteoarthritis who received an APTUS wrist fusion system after 01.01.2014
Rheumatoid Arthritis wrist destruction	Total wrist fusion	Patients with rheumatoid arthritis who received an APTUS wrist fusion system after 01.01.2014

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functional assessment: Goniometry	all patients who underwent surgery between 2014 to 2022	ROM of each joint of the hand with a goniometer.
Function	all patients who underwent surgery between 2014 to 2022	Grip force of the hand in Kg
Postoperative complications	all patients who underwent surgery between 2014 to 2022	Number of Participants with impaired wound healing, Re-surgery, Material loosening
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

Trial Locations

Locations (1)

Waldfriede Hospital; 🇩🇪 Berlin, Germany