Wrist ArthritisSTIFNCT05875896
Study of Wrist Fusions With the Medartis Aptus Arthrodesis Plate
An observational study of Wrist Arthritis and Wrist Osteoarthritis, run by Waldfriede Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wrist Arthritis, Wrist Osteoarthritis
- What is being tested?
- Total wrist fusion
- Type of treatment
- Surgery or procedure
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jun 2023to 4 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- post surgery bone fracture of the same limb
- Pregnancy, lactation
- active malignant tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Functional Status After Wrist Arthrodesis (Medartis Aptus Model) in Patients With Rheumatoid Arthritis Compared to Patients With Post-traumatic Wrist Destruction
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.
- Conditions
- Wrist Arthritis, Wrist Osteoarthritis
- Being tested
- Total wrist fusion
- Keywords
- Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total wrist fusionProcedure or surgery
Observation after implantation of Medartis Aptus Wrist Arthrodesis Plate
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis wrist destruction | Patients with rheumatoid arthritis who received an APTUS wrist fusion system after 01.01.2014 Receives: Procedure: Total wrist fusion | |
| Osteoarthritis wrist destruction | Patients with post-traumatic wrist osteoarthritis who received an APTUS wrist fusion system after 01.01.2014 Receives: Procedure: Total wrist fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: all patients who underwent surgery between 2014 to 2022
Secondary outcomes (5)
Postoperative complications
Number of Participants with impaired wound healing, Re-surgery, Material loosening
Measured: all patients who underwent surgery between 2014 to 2022
Function
Grip force of the hand in Kg
Measured: all patients who underwent surgery between 2014 to 2022
Functional assessment: Goniometry
ROM of each joint of the hand with a goniometer.
Measured: all patients who underwent surgery between 2014 to 2022
Visual analogue scale (VAS) Pain
From 0mm (no pain) to 100mm (maximum pain imaginable)
Measured: all patients who underwent surgery between 2014 to 2022
Short-Form 36 (SF-36)
Scored review of health questionnaire SF36: minimum value = 0 ; maximum value = 100
Measured: all patients who underwent surgery between 2014 to 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start6 Jun 2023
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waldfriede Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lautenbach Martin, MD, Study chair, Hospital Waldfriede, Argentinische Allee 40, 14163 BerlinMarkus Bock, MD, Principal investigator, Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875896
- Sponsor's protocol ID
- BB040/23
- Acronym
- STIF
- Status last verified
- Jan 2024
- First submitted
- 2 May 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Functional Status After Wrist Arthrodesis (Medartis Aptus Model) in Patients With Rheumatoid Arthritis Compared to Patients With Post-traumatic Wrist Destruction
- ClinicalTrials.gov ID
- NCT05875896
- Acronym / sponsor ID
- STIF / BB040/23
- Conditions
- Wrist Arthritis, Wrist Osteoarthritis
- Keywords
- Wrist fusion,Arthrodesis,Rheumatoid Arthritis,Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Waldfriede HospitalUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis wrist destruction | – | Procedure: Total wrist fusionPatients with rheumatoid arthritis who received an APTUS wrist fusion system after 01.01.2014 |
| Osteoarthritis wrist destruction | – | Procedure: Total wrist fusionPatients with post-traumatic wrist osteoarthritis who received an APTUS wrist fusion system after 01.01.2014 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- post surgery bone fracture of the same limb
- Pregnancy, lactation
- active malignant tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total wrist fusionObservation after implantation of Medartis Aptus Wrist Arthrodesis Plate | Procedure or surgery | Osteoarthritis wrist destruction, Rheumatoid Arthritis wrist destruction |
Primary outcome
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Time frame: all patients who underwent surgery between 2014 to 2022
Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)
5 secondary outcomes
Postoperative complications
Time frame: all patients who underwent surgery between 2014 to 2022
Function
Time frame: all patients who underwent surgery between 2014 to 2022
Functional assessment: Goniometry
Time frame: all patients who underwent surgery between 2014 to 2022
Visual analogue scale (VAS) Pain
Time frame: all patients who underwent surgery between 2014 to 2022
Short-Form 36 (SF-36)
Time frame: all patients who underwent surgery between 2014 to 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lautenbach Martin, MD study chair
Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
Markus Bock, MD principal investigator
Hospital Waldfriede, Argentinische Allee 40, 14163 Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wrist Arthritis and Wrist Osteoarthritis, run by Waldfriede Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) (time frame: all patients who underwent surgery between 2014 to 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.