Osteoarthritis Metacarpophalangeal JointFLEXNCT06154421
Metacarpophalangeal Joint Prostheses in Hand Surgery.
An observational study of Osteoarthritis Metacarpophalangeal Joint and Rheumatoid Arthritis Metacarpophalangeal Joint, run by Waldfriede Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis Metacarpophalangeal Joint, Rheumatoid Arthritis Metacarpophalangeal Joint
- What is being tested?
- Metacarpophalangeal joint prostheses
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 4 Jan 2024to 30 Jun 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 Metacarpophalangeal joint destruction due to rheumatiod arthritis inflammation, or individuals who have received joint implant due to post-traumatic osteoarthritis of the Metacarpophalangeal joint.
Who may be able to join
- 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
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.
Germany1 site, 1 recruiting
- Recruiting
Waldfriede Hospital
Berlin, 14163
Markus Bock, MD, 00493081810201, m.bock@waldfriede.de
About this study
Official title: Metacarpophalangeal Joint Prostheses in Hand Surgery. A Retrospective Investigation on Functional Outcome After Intervention.
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.
- Being tested
- Metacarpophalangeal joint prostheses
- Keywords
- metacarpophalangeal joint prostheses, Swanson flexible finger joint implant, finger joint replacement, Osteoarthritis, Rheumatoid Arthritis, metacarpophalangeal joint arthroplasty, KeriFlex® finger joint prostheses
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacarpophalangeal joint prosthesesProcedure or surgery
Observation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants
Metacarpophalangeal joint prosthesesProcedure or surgery
Observation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis finger joint destruction | Patients with rheumatoid arthritis who received a metacarpophalangeal joint prostheses system after 01.01.2014 Receives: 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 Receives: Procedure: Metacarpophalangeal joint prostheses |
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 2023
Secondary outcomes (3)
Functional assessment: Goniometry
ROM of each joint of the hand with a goniometer
Measured: All patients who underwent surgery between 2014 to 2023
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 2023
Ultrasound Assessment
Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
Measured: All patients who underwent surgery between 2014 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start4 Jan 2024
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Metacarpophalangeal JointStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waldfriede Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Lautenbach, 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
- NCT06154421
- Sponsor's protocol ID
- BB163-23
- Acronym
- FLEX
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2023
- Last updated
- 5 Jan 2024
- Results posted
- 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
- Metacarpophalangeal Joint Prostheses in Hand Surgery. A Retrospective Investigation on Functional Outcome After Intervention.
- ClinicalTrials.gov ID
- NCT06154421
- Acronym / sponsor ID
- FLEX / BB163-23
- Keywords
- metacarpophalangeal joint prostheses, Swanson flexible finger joint implant, finger joint replacement, Osteoarthritis, Rheumatoid Arthritis, metacarpophalangeal joint arthroplasty, KeriFlex® finger joint prostheses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Waldfriede HospitalUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 4 Dec 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis finger joint destruction | – | Procedure: Metacarpophalangeal joint prosthesesPatients with rheumatoid arthritis who received a metacarpophalangeal joint prostheses system after 01.01.2014 |
| Osteoarthritis finger joint destruction | – | Procedure: Metacarpophalangeal joint prosthesesPatients with post-traumatic wrist osteoarthritis who received a metacarpophalangeal joint prostheses 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 Metacarpophalangeal joint destruction due to rheumatiod arthritis inflammation, or individuals who have received joint implant due to post-traumatic osteoarthritis of the Metacarpophalangeal joint.
Key inclusion criteria (3 listed)
- Age 18-90
- Metacarpophalangeal Joint Prostheses between 2014 and 2022 using Swanson or KeriFlex implant system at Hospital Waldfriede
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 |
|---|---|---|
| Metacarpophalangeal joint prosthesesObservation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants | Procedure or surgery | Rheumatoid Arthritis finger joint destruction |
| Metacarpophalangeal joint prosthesesObservation after implantation of metacarpophalangeal joint prostheses using KeriFlex® or Swanson finger joint implants | Procedure or surgery | Osteoarthritis finger joint destruction |
Primary outcome
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Time frame: All patients who underwent surgery between 2014 to 2023
Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)
3 secondary outcomes
Functional assessment: Goniometry
Time frame: All patients who underwent surgery between 2014 to 2023
Short-Form 36 (SF-36)
Time frame: All patients who underwent surgery between 2014 to 2023
Ultrasound Assessment
Time frame: All patients who underwent surgery between 2014 to 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis Metacarpophalangeal Joint
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Active, not recruitingPhase 1/2
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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.
Martin Lautenbach, 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 Osteoarthritis Metacarpophalangeal Joint and Rheumatoid Arthritis Metacarpophalangeal Joint, 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 3 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus Bock, MD (00493081810201, m.bock@waldfriede.de), or a site near the patient. 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 2023). 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.