Orlando Health
Orlando, Florida, 32806, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07068893
A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations
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).
Recruiting
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Conditions
Age range
18 year–88 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Skeletally mature patients who have undergone surgical fixation of perilunate dislocation
Exclusion criteria
- 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
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
Specific types of complications and their incidence rates
Time frame: From enrollment to 2-years postoperative
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.).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Bryan D Brown,MD
Other
Registry information
Official study title
A 4-Anchor Construct With Internal Bracing Technique for Surgical Treatment of Perilunate Dislocations: A Prospective Study
Important dates
- Study start
- 2025
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jul 16, 2025
- Registry last updated
- Dec 9, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.