ClinicalTrials.gg
RecruitingNCT06154421FLEXUpdated Jan 5, 2024

Metacarpophalangeal Joint Prostheses in Hand Surgery.

An observational study in Osteoarthritis Metacarpophalangeal Joint and Rheumatoid Arthritis Metacarpophalangeal Joint, sponsored by Waldfriede Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-01-05.

Sponsored by Waldfriede Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 131 studies in Osteoarthritis with a site in Germany — 12 open to participants now, 27 under way, 3 of them phase 3. Osteoarthritis · Germany.

Planned enrollment
16th of 31
100 · median 100
Started
2024
with 5 others
Observational
31 of 131
3 open now
Primary completion
2024-04
later than 3 of 26 live
Registered
120th of 131
by date

Among the 131 studies in Osteoarthritis with a site in Germany, this one is the 16th largest by planned enrollment of the 31 observational ones that give a count, is one of 6 that started in 2024, is one of 31 observational ones, reaches primary completion later than 3 of the 26 other live ones, and was the 120th registered.

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 437 are open to participants now.

Browse Osteoarthritis studies →

Open to participants now

12 of the 131 studies in Osteoarthritis with a site in Germany are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →

Who these studies take

Of the 286 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • post surgery bone fracture of the same limb
  • Pregnancy, lactation
  • active malignant tumor
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureMetacarpophalangeal joint prostheses

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

  • ProcedureMetacarpophalangeal joint prostheses

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

06

What researchers measure

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)

    Time frame: All patients who underwent surgery between 2014 to 2023

Secondary outcomes

  1. Functional assessment: Goniometry

    ROM of each joint of the hand with a goniometer

    Time frame: All patients who underwent surgery between 2014 to 2023

  2. Short-Form 36 (SF-36)

    Scored review of health questionnaire SF36: minimum value = 0 ; maximum value = 100

    Time frame: All patients who underwent surgery between 2014 to 2023

  3. Ultrasound Assessment

    Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.

    Time frame: All patients who underwent surgery between 2014 to 2023

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Apr 2024, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2023
First posted
Dec 4, 2023
StartActual
Jan 4, 2024
Primary completionEst.
Apr 30, 2024
CompletionEst.
Jun 30, 2024
Last update
Jan 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06154421
Lead sponsor
Waldfriede Hospital
Responsible party
Sponsor
First posted
Dec 4, 2023
Start date
Jan 4, 2024
Primary completion
Apr 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Jan 5, 2024

Study contacts

Markus Bock, MD
Contact
m.bock@waldfriede.de
00493081810201
Martin Lautenbach, MD
study chair · Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
Markus Bock, MD
principal investigator · Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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