Recruiting

Internal Brace vs. K-wire

Sponsor:

Bryan D Brown,MD

Code:

NCT07068893

Conditions

Perilunate Dislocation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.). 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

Study ID

NCT07068893

Start date

Sep 17, 2025

Status verified date

Dec, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients who undergo traditional fixation

Patients who undergo fixation using a novel 4-anchor construct with internal bracing

Primary outcome measure

  • Clinical Functional Assessment [ Time Frame: From enrollment to 2-years postoperative ]
  • Quick DASH Form [ Time Frame: From enrollment to 2-years postoperative ]

Central Contacts and Locations

Central contacts

Bryan Brown, MD

321-890-7154Bryan.Brown@orlandohealth.com

Locations

Orlando Health

Recruiting

Orlando, Florida, United States, 32806

Contacts

Bryan Brown, MD

321-890-7154Bryan.Brown@orlandohealth.com

More Information

Sponsor

Bryan D Brown,MD

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bryan D Brown,MD on 2025-12-09.