Proximal Interphalangeal Joint Fracture of the HandDYNAFIXNCT04470349
Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures
An observational study of Proximal Interphalangeal Joint Fracture of the Hand, run by Waldfriede Hospital at 1 site in Germany.
Trial summary
Fractures of the proximal interphalangeal joints continue to pose significant management challenges. Thus the aim of our study is to compare two dynamic finger joint distractors (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination and functional assessments. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Proximal Interphalangeal Joint Fracture of the Hand
- What is being tested?
- LITOS and Ligamentotaxor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2020to 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: People who have sustained a proximal interphalangeal fracture treated with external dynamic fixator
Who may be able to join
- proximal interphalangeal fracture treated with external dynamic fixator
- Operative care <21 days from trauma
- Age between 18 and 90 years.
- Male and female
Who cannot join
- additional fractures or disabilities of the hand
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
Fractures of the proximal interphalangeal joints continue to pose significant management challenges. Thus the aim of our study is to compare two dynamic finger joint distractors (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination and functional assessments.
- Being tested
- LITOS, Ligamentotaxor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LITOSDevice
Patients who received a LITOS dynamic distraction system after 31.12.2017
LigamentotaxorDevice
Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017
| Study group | Role | What they receive |
|---|---|---|
| LITOS | Patients who received a LITOS dynamic distraction system after 31.12.2017 Receives: Device: LITOS | |
| Ligamentotaxor | Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017 Receives: Device: Ligamentotaxor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of Arm, Shoulder and Hand (DASH) score
Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)
Measured: 3 months after explantation
Secondary outcomes (2)
Visual analogue scale (VAS) pain
From 0mm (no pain) to 100mm (maximum pain imaginable)
Measured: 3 months after explantation
Functional assessment: Goniometry
ROM of each joint of the injured fingert with a goniometer.
Measured: 3 months after explantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start14 Jul 2020
- Primary completion31 Dec 2023 (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 Proximal Interphalangeal Joint Fracture of the HandStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waldfriede Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Bock, MD, Principal investigator, Waldfriede HospitalMartin Lautenbach, MD, Study chair, Waldfriede Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470349
- Sponsor's protocol ID
- 2020.1
- Acronym
- DYNAFIX
- Status last verified
- Jan 2023
- First submitted
- 8 Jul 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dynamic Distraction Systems in Proximal Interphalangeal Joint Fractures
- ClinicalTrials.gov ID
- NCT04470349
- Acronym / sponsor ID
- DYNAFIX / 2020.1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Waldfriede HospitalUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 14 Jul 2020 (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.
Fractures of the proximal interphalangeal joints continue to pose significant management challenges. Thus the aim of our study is to compare two dynamic finger joint distractors (Litos® and Ligamentotaxor®) in respect to the radiological standard follow-up examination and functional assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LITOS | – | Device: LITOSPatients who received a LITOS dynamic distraction system after 31.12.2017 |
| Ligamentotaxor | – | Device: LigamentotaxorPatients who received a Ligamentotaxor dynamic distraction system after 31.12.2017 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have sustained a proximal interphalangeal fracture treated with external dynamic fixator
Key inclusion criteria (4 listed)
- proximal interphalangeal fracture treated with external dynamic fixator
- Operative care <21 days from trauma
- Age between 18 and 90 years.
- Male and female
Key exclusion criteria (1 listed)
- additional fractures or disabilities of the hand
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 |
|---|---|---|
| LITOSPatients who received a LITOS dynamic distraction system after 31.12.2017 | Device | LITOS |
| LigamentotaxorPatients who received a Ligamentotaxor dynamic distraction system after 31.12.2017 | Device | Ligamentotaxor |
Primary outcome
Disabilities of Arm, Shoulder and Hand (DASH) score
Time frame: 3 months after explantation
Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)
2 secondary outcomes
Visual analogue scale (VAS) pain
Time frame: 3 months after explantation
Functional assessment: Goniometry
Time frame: 3 months after explantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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.
Markus Bock, MD principal investigator
Waldfriede Hospital
Martin Lautenbach, MD study chair
Waldfriede Hospital
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 Proximal Interphalangeal Joint Fracture of the Hand, 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 1 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 26 Jan 2023. 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 Arm, Shoulder and Hand (DASH) score (time frame: 3 months after explantation). 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 26 Jan 2023.