Metacarpophalangeal Joint Prostheses in Hand Surgery. (FLEX)

Waldfriede Hospital

Status: Enrolling

Conditions: Rheumatoid Arthritis Metacarpophalangeal Joint; Osteoarthritis Metacarpophalangeal Joint

Treatments: Procedure: Metacarpophalangeal joint prostheses

Study type: Observational

Funder types: Other

Identifiers

NCT06154421

BB163-23

Details and patient eligibility

About

The primary working hypothesis of this study is whether KeriFlex® metacarpophalangeal joint prostheses provide an equivalent result to Swanson finger joint implants in patients with rheumatoid arthritis or 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: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-90

• Metacarpophalangeal Joint Prostheses between 2014 and 2022 using Swanson or KeriFlex implant system at Hospital Waldfriede

  • rheumatoid Arthritis or post-traumatic osteoarthritis of Metacarpophalangeal joint

Exclusion criteria

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

Trial design

100 participants in 2 patient groups

Rheumatoid Arthritis finger joint destruction

Description:

Patients with rheumatoid arthritis who received a metacarpophalangeal joint prostheses system after 01.01.2014

Treatment:

Procedure: Metacarpophalangeal joint prostheses

Procedure: Metacarpophalangeal joint prostheses

Osteoarthritis finger joint destruction

Description:

Patients with post-traumatic wrist osteoarthritis who received a metacarpophalangeal joint prostheses system after 01.01.2014

Treatment:

Procedure: Metacarpophalangeal joint prostheses

Procedure: Metacarpophalangeal joint prostheses