Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

Wrist Arthritis Clinical Trial

— STIF  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05875896
• Other study ID #: BB040/23
• Status: Completed
• Start date: June 6, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Waldfriede Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Arthritis
• Osteoarthritis
• Wrist Arthritis
• Wrist Osteoarthritis

Intervention

Procedure:
• Total wrist fusion
Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

Locations

Country	Name	City	State
Germany	Waldfriede Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Waldfriede Hospital

Country where clinical trial is conducted

Germany, 

Outcome

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