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

W

Waldfriede Hospital

Status

Completed

Conditions

Wrist Arthritis
Wrist Osteoarthritis

Treatments

Procedure: Total wrist fusion

Study type

Observational

Funder types

Other

Identifiers

NCT05875896
BB040/23

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

73 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Marlène O'Donoghue

Data sourced from clinicaltrials.gov

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