ClinicalTrials.gg
CompletedNCT05875896STIFUpdated Jan 5, 2024

Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate

An observational study in Wrist Arthritis and Wrist Osteoarthritis, sponsored by Waldfriede Hospital. Completed 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

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
73
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.

Enrollment
18th of 31
73 · median 100
Started
2023
with 5 others
Observational
31 of 131
3 open now
Registered
116th of 131
by date

Among the 131 studies in Osteoarthritis with a site in Germany, this one is the 18th largest by enrollment of the 31 observational ones that give a count, is one of 6 that started in 2023, is one of 31 observational ones, and was the 116th 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:

7 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.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 131 studies in Osteoarthritis with a site in Germany, or all of them as a file.
02

Study summary

The primary working hypothesis of this study is whether wrist arthrodesis leads to an improvement in functional status in both rheumatoid arthritis and 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

  • Wrist Arthritis
  • Wrist Osteoarthritis

Browse trials for

Keywords

  • Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis
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 wrist destruction due to rheumatiod arthritis inflammation, or individuals who have received wrist fusion due to post-traumatic osteoarthritis.

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
  • Wrist fusion took place between 2014 and 2022 using Aptus 2.5 TriLock Total Wrist Fusion Plate, Medartis at Hospital Waldfriede
  • rheumatoid Arthritis
  • post-traumatic osteoarthritis patterns: 1. scapholunate advanced collapse (SLAC) or 2. scaphoid nonunion advanced collapse (SNAC)

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
73 participants (actual)
Patient registry
No

Groups and cohorts

  • Rheumatoid Arthritis wrist destruction

    Patients with rheumatoid arthritis who received an APTUS wrist fusion system after 01.01.2014

    Procedure: Total wrist fusion

  • Osteoarthritis wrist destruction

    Patients with post-traumatic wrist osteoarthritis who received an APTUS wrist fusion system after 01.01.2014

    Procedure: Total wrist fusion

Interventions

  • ProcedureTotal wrist fusion

    Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate

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 2022

Secondary outcomes

  1. Postoperative complications

    Number of Participants with impaired wound healing, Re-surgery, Material loosening

    Time frame: all patients who underwent surgery between 2014 to 2022

  2. Function

    Grip force of the hand in Kg

    Time frame: all patients who underwent surgery between 2014 to 2022

  3. Functional assessment: Goniometry

    ROM of each joint of the hand with a goniometer.

    Time frame: all patients who underwent surgery between 2014 to 2022

  4. Visual analogue scale (VAS) Pain

    From 0mm (no pain) to 100mm (maximum pain imaginable)

    Time frame: all patients who underwent surgery between 2014 to 2022

  5. 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 2022

07

Study locations

1 site
  • Waldfriede Hospital
    Berlin, 14163, Germany
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

Ran from Jun 2023 to primary completion in Jan 2024, 6 months.

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

Registered
May 2, 2023
First posted
May 25, 2023
StartActual
Jun 6, 2023
Primary completionActual
Jan 4, 2024
CompletionActual
Jan 4, 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
NCT05875896
Lead sponsor
Waldfriede Hospital
Responsible party
Sponsor
First posted
May 25, 2023
Start date
Jun 6, 2023
Primary completion
Jan 4, 2024
Completion
Jan 4, 2024
Last update
Jan 5, 2024

Study contacts

Lautenbach Martin, MD
study chair · Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
Markus Bock, MD
principal investigator · Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion