Perilunate DislocationNCT07068893
A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations
An observational study of Perilunate Dislocation, run by Bryan D Brown,MD at 1 site in United States.
Trial summary
The purpose of the research study is to determine the overall clinical and radiographic outcome differences between internal brace technique and the gold standard Kirschner wires (K-wire) technique for treatment of perilunate dislocations (e.g. nonunion, reoperation, infection, fixation failure, etc.). Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Perilunate Dislocation
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2025to Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients, 18 years of age and older, who undergo operative fixation for perilunate dislocations without fracture at the level one trauma center, Orlando Health Orlando Regional Medical Center.
Who may be able to join
- Skeletally mature patients who have undergone surgical fixation of perilunate dislocation
Who cannot join
- Perilunate dislocations with concomitant carpal fracture(s)
- Pediatric patients (Age < 18 years-old)
- Patients whose age is greater than or equal to 89 years
- History of previous perilunate dislocation on ipsilateral side
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Orlando Health
Orlando, Florida, 32806
Bryan Brown, MD, 321-890-7154, Bryan.Brown@orlandohealth.com
About this study
Official title: A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations: A Prospective Study
The purpose of the research study is to determine the overall clinical and radiographic outcome differences between internal brace technique and the gold standard Kirschner wires (K-wire) technique for treatment of perilunate dislocations (e.g. nonunion, reoperation, infection, fixation failure, etc.). A secondary purpose is to determine the specific types of complications and their incidence rates with respect to internal brace technique and the gold standard Kirschner wires (K-wire) technique (e.g. range of motion losses, pain, numbness, weakness, etc).
- Conditions
- Perilunate Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo traditional fixation | Not described | |
| Patients who undergo fixation using a novel 4-anchor construct with internal bracing | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Functional Assessment
assessment to measure wrist flexion/extension (degrees), wrist flexion/extension arc (degrees), and composite wrist function
Measured: From enrollment to 2-years postoperative
Quick DASH Form
Assessment of symptoms and ability to perform certain activities.
Measured: From enrollment to 2-years postoperative
Secondary outcomes (1)
Specific types of complications and their incidence rates
Determine the specific types of complications and their incidence rates with respect to internal brace technique and the gold standard Kirschner wires (K-wire) technique (e.g. range of motion losses, pain, paresthesias, weakness, etc.).
Measured: From enrollment to 2-years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start17 Sep 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perilunate DislocationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bryan D Brown,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bryan D Brown,MD, Orlando Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068893
- Sponsor's protocol ID
- 25.007.01
- Status last verified
- Dec 2025
- First submitted
- 23 Jun 2025
- Last updated
- 9 Dec 2025
- 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 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations: A Prospective Study
- ClinicalTrials.gov ID
- NCT07068893
- Acronym / sponsor ID
- 25.007.01
- Conditions
- Perilunate Dislocation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bryan D Brown,MDUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 16 Jul 2025 (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 purpose of the research study is to determine the overall clinical and radiographic outcome differences between internal brace technique and the gold standard Kirschner wires (K-wire) technique for treatment of perilunate dislocations (e.g. nonunion, reoperation, infection, fixation failure, etc.). A secondary purpose is to determine the specific types of complications and their incidence rates with respect to internal brace technique and the gold standard Kirschner wires (K-wire) technique (e.g. range of motion losses, pain, numbness, weakness, etc).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo traditional fixation | – | – |
| Patients who undergo fixation using a novel 4-anchor construct with internal bracing | – | – |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients, 18 years of age and older, who undergo operative fixation for perilunate dislocations without fracture at the level one trauma center, Orlando Health Orlando Regional Medical Center.
Key inclusion criteria (1 listed)
- Skeletally mature patients who have undergone surgical fixation of perilunate dislocation
Key exclusion criteria (4 listed)
- Perilunate dislocations with concomitant carpal fracture(s)
- Pediatric patients (Age < 18 years-old)
- Patients whose age is greater than or equal to 89 years
- History of previous perilunate dislocation on ipsilateral side
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Functional Assessment
Time frame: From enrollment to 2-years postoperative
assessment to measure wrist flexion/extension (degrees), wrist flexion/extension arc (degrees), and composite wrist function
Quick DASH Form
Time frame: From enrollment to 2-years postoperative
Assessment of symptoms and ability to perform certain activities.
1 secondary outcome
Specific types of complications and their incidence rates
Time frame: From enrollment to 2-years postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Perilunate Dislocation
RecruitingObservational study
The Canadian Prospective Pragmatic Perilunate Outcomes Trial
Wrist Injuries, Carpal Bone Fracture
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.
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 Perilunate Dislocation, run by Bryan D Brown,MD at 1 site in United States.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Brown, MD (321-890-7154, Bryan.Brown@orlandohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Functional Assessment (time frame: From enrollment to 2-years postoperative). The study lists 2 primary outcomes in all. 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 9 Dec 2025.