Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

NCT05875896 | Completed

• 1 other identifier: BB040/23
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Wrist Arthritis; Wrist Osteoarthritis

Keywords

Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative complications

  all patients who underwent surgery between 2014 to 2022

• Function

  all patients who underwent surgery between 2014 to 2022

• Functional assessment: Goniometry

  all patients who underwent surgery between 2014 to 2022

• Visual analogue scale (VAS) Pain

  all patients who underwent surgery between 2014 to 2022

• Short-Form 36 (SF-36)

  all patients who underwent surgery between 2014 to 2022

Study Arms (2)

Rheumatoid Arthritis wrist destruction

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

Procedure: Total wrist fusion

Osteoarthritis wrist destruction

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

Procedure: Total wrist fusion

Interventions

Total wrist fusion PROCEDURE

Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

Osteoarthritis wrist destruction; Rheumatoid Arthritis wrist destruction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• post surgery bone fracture of the same limb
• Pregnancy, lactation
• active malignant tumor

Sponsors & Collaborators

• Waldfriede Hospital: lead

Study Sites (1)

Waldfriede Hospital

Berlin, 14163, Germany

Location

Study Officials

• Lautenbach Martin, MD

  Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

  STUDY CHAIR

• Markus Bock, MD

  Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 25, 2023
• Study Start: June 6, 2023
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Locations

DE (1)