Metacarpophalangeal Joint Prostheses in Hand Surgery.

NCT ID: NCT06154421

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-04

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Metacarpophalangeal Joint Rheumatoid Arthritis Metacarpophalangeal Joint

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Rheumatoid Arthritis finger joint destruction

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

Metacarpophalangeal joint prostheses

Intervention Type PROCEDURE

Observation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants

Osteoarthritis finger joint destruction

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

Metacarpophalangeal joint prostheses

Intervention Type PROCEDURE

Observation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants

Interventions

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Metacarpophalangeal joint prostheses

Observation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants

Intervention Type PROCEDURE

Metacarpophalangeal joint prostheses

Observation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Waldfriede Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Lautenbach, MD

Role: STUDY_CHAIR

Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Markus Bock, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Locations

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Waldfriede Hospital

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Markus Bock, MD

Role: CONTACT

00493081810201

Facility Contacts

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Markus Bock, MD

Role: primary

00493081810201

Other Identifiers

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BB163-23

Identifier Type: -

Identifier Source: org_study_id

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