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Metacarpophalangeal Joint Prostheses in Hand Surgery.

Metacarpophalangeal Joint Prostheses in Hand Surgery. A Retrospective Investigation on Functional Outcome After Intervention.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06154421
Acronym
FLEX
Enrollment
100
Registered
2023-12-04
Start date
2024-01-04
Completion date
2024-06-30
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Metacarpophalangeal Joint, Rheumatoid Arthritis Metacarpophalangeal Joint

Keywords

metacarpophalangeal joint prostheses, Swanson flexible finger joint implant, finger joint replacement, Osteoarthritis, Rheumatoid Arthritis, metacarpophalangeal joint arthroplasty, KeriFlex® finger joint prostheses

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.

Interventions

PROCEDUREMetacarpophalangeal joint prostheses

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

Sponsors

Waldfriede Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)All patients who underwent surgery between 2014 to 2023Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)

Secondary

MeasureTime frameDescription
Functional assessment: GoniometryAll patients who underwent surgery between 2014 to 2023ROM of each joint of the hand with a goniometer
Short-Form 36 (SF-36)All patients who underwent surgery between 2014 to 2023Scored review of health questionnaire SF36: minimum value = 0 ; maximum value = 100
Ultrasound AssessmentAll patients who underwent surgery between 2014 to 2023Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.

Countries

Germany

Contacts

Primary ContactMarkus Bock, MD
m.bock@waldfriede.de00493081810201

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026