Perilunate Management

NCT05824078 | Terminated

• 2 other identifiers: STUDY000050882025P013453
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Perilunate Injury

Keywords

Carpus; Arthroscopy; Open surgery

Outcome Measures

Primary Outcomes (1)

• Pain Numeric Rating Scale (NRS)

  The numeric rating scale is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.

  12 weeks post-operation

Secondary Outcomes (1)

• Range of motion

  12 weeks post-operation

Study Arms (2)

Open procedure

ACTIVE COMPARATOR

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.

Procedure: Open Surgery

Arthroscopic Procedure

ACTIVE COMPARATOR

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.

Procedure: Arthroscopic surgery

Interventions

Arthroscopic surgery 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.

Arthroscopic Procedure

Open Surgery 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.

Open procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 a specific surgical approach for their treatment cannot be randomly allocated to one of the study arms, so they 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 the influence.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

MeSH Terms

Interventions

Arthroscopy; Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Nicole Zelenski, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

• Eric R Wagner, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 21, 2023
• Study Start: July 3, 2023
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)