Perilunate Management

NCT ID: NCT05824078

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-03
• Study Completion Date: 2030-12-31

Brief Summary

Perilunate injuries can be debilitating injuries that involve the carpus. These can limit patients' functionality both acutely and long-term. Not only do their potential for nerve injury increase risk of lasting weakness and chronic pain, but their complex surrounding involving the carpus also leads to potential for misalignment when healing. The approach for treating perilunate injuries often relies on internal fixation, prompting the need for surgery. However, there is no clear recommendation for whether to pursue open or arthroscopic surgery as both offer benefits and pose risks.

The aim of this study is to determine the similarities and differences in outcomes for management of perilunate injuries.

Detailed Description

Perilunate injuries are those that affect the wrist, which can be debilitating to patients. Often, these injuries require surgical treatment, which can either be performed open or arthroscopic. There is currently no consensus for which approach offers better outcomes. Therefore, this study will allocate patients who require surgical treatment of perilunate injuries to either open or arthroscopic surgical intervention to compare their outcomes. The results will offer insight into the compromises made with each surgical approach and create a foundation orthopedic surgeons can leverage to decide how to manage a patient to ensure best possible outcomes.

This study will involve 12 patients who were identified as having perilunate injuries requiring orthopedic surgical treatment. Their participation will involve consenting to be randomly allocated to the surgical approach, and they will be asked to complete commonly used orthopedic surveys (eg DASH score) that are used to evaluate the functional healing of their injury. They will be followed for up to 1 year after their surgery. A chart review will be conducted to follow their progress and surgical outcomes.

Patients will be recruited from Grady Memorial Hospital. No specimens will be collected or banked for this study.

Conditions

Perilunate Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Open procedure

The study intervention involved in this project is the randomized allocation of the patient who requires surgical treatment of their perilunate injury to receive either an open or arthroscopic approach for the procedure.

Once the patient is in agreement to have surgery and has consented to partake in the study, they will be randomly allocated to either open perilunate surgery or arthroscopic perilunate surgery.

Both surgical approaches are well-recognized, common, standard-of-care procedures.

Group Type: ACTIVE_COMPARATOR

Open Surgery

Intervention Type: PROCEDURE

The open approach requires dissection of capsuloligamentous structures, which can lead to stiffness of the joint due to capsular scarring as it heals. However, it offers good visual field when treating the injury, allowing maneuverability to avoid iatrogenic soft tissue injuries.

Arthroscopic Procedure

The study intervention involved in this project is the randomized allocation of the patient who requires surgical treatment of their perilunate injury to receive either an open or arthroscopic approach for the procedure.

Once the patient is in agreement to have surgery and has consented to partake in the study, they will be randomly allocated to either open perilunate surgery or arthroscopic perilunate surgery.

Both surgical approaches are well-recognized, common, standard-of-care procedures.

Group Type: ACTIVE_COMPARATOR

Arthroscopic surgery

Intervention Type: PROCEDURE

Arthroscopic approach involves smaller incision, offering less traumatic procedures and faster healing, but due to the limited space in this closed field with significant vasculature and nerve distribution, scoping has increased risk for iatrogenic injuries.

Interventions

Arthroscopic surgery

Arthroscopic approach involves smaller incision, offering less traumatic procedures and faster healing, but due to the limited space in this closed field with significant vasculature and nerve distribution, scoping has increased risk for iatrogenic injuries.

Intervention Type: PROCEDURE

Open Surgery

The open approach requires dissection of capsuloligamentous structures, which can lead to stiffness of the joint due to capsular scarring as it heals. However, it offers good visual field when treating the injury, allowing maneuverability to avoid iatrogenic soft tissue injuries.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All adult patients (18 years old and older).
• Patients requiring surgical intervention for a perilunate injury will be consented and then randomly allocated to either open or arthroscopic surgery.

Exclusion Criteria

• Prisoners will not be included in this study.
• Patients younger than 18 years old and pregnant patients will be excluded from this review.
• Patients who require specific surgical approach for their treatment, cannot be randomly allocated to one of the study arms, so will be excluded from this study.
• The study will not include data from minors, cognitively impaired individuals, or individuals who are vulnerable to coercion or under influence.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nicole Zelenski

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole Zelenski, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Eric R Wagner, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Zelenski, MD

Role: CONTACT

nicole.ann.zelenski@emory.edu

404-255-0226

Jasone Barron

Role: CONTACT

jason.barron@emory.edu

404-778-3242

Facility Contacts

Nicole Zelenski, MD

Role: primary

nicole.ann.zelenski@emory.edu

Role: backup

olodise@emory.edu

Other Identifiers

STUDY00005088

Identifier Type: -

Identifier Source: org_study_id