NCT06154421

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

November 23, 2023

Last Update Submit

January 4, 2024

Conditions

Osteoarthritis Metacarpophalangeal JointRheumatoid Arthritis Metacarpophalangeal Joint

Keywords

metacarpophalangeal joint prosthesesSwanson flexible finger joint implantfinger joint replacementOsteoarthritisRheumatoid Arthritismetacarpophalangeal joint arthroplastyKeriFlex® finger joint prostheses

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 2023

Secondary Outcomes (3)

  • Functional assessment: Goniometry

    All patients who underwent surgery between 2014 to 2023

  • Short-Form 36 (SF-36)

    All patients who underwent surgery between 2014 to 2023

  • Ultrasound Assessment

    All patients who underwent surgery between 2014 to 2023

Study Arms (2)

Rheumatoid Arthritis finger joint destruction

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

Procedure: Metacarpophalangeal joint prostheses

Osteoarthritis finger joint destruction

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

Procedure: Metacarpophalangeal joint prostheses

Interventions

Metacarpophalangeal joint prosthesesPROCEDURE

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

Rheumatoid Arthritis finger joint destruction

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have either suffered Metacarpophalangeal joint destruction due to rheumatiod arthritis inflammation, or individuals who have received joint implant due to post-traumatic osteoarthritis of the Metacarpophalangeal joint.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waldfriede Hospital

Berlin, 14163, Germany

RECRUITING

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Martin Lautenbach, MD

    Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

    STUDY CHAIR

  • Markus Bock, MD

    Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Markus Bock, MD

CONTACT

00493081810201m.bock@waldfriede.de

Study Design

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

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 4, 2023

Study Start

January 4, 2024

Primary Completion

April 30, 2024

Study Completion

June 30, 2024

Last Updated

January 5, 2024

Record last verified: 2024-01

Locations

DE(1)