Perilunate Management

Outcomes of Perilunate Injury Management: Open vs Arthroscopic Approach

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.

Study Overview

• Status: Recruiting
• Conditions: Perilunate Injury
• Intervention / Treatment: Procedure: Open Surgery; Procedure: Arthroscopic surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Zelenski, MD; Phone Number: 404-255-0226; Email: nicole.ann.zelenski@emory.edu
• Study Contact Backup: Name: Olivia Jagiella-Lodise; Phone Number: 404-255-0226; Email: olodise@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Memorial Hospital
      • Contact: Nicole Zelenski, MD; Email: nicole.ann.zelenski@emory.edu
      • Contact: Email: olodise@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Range of motion (ROM) means the extent or limit to which a part of the body can be moved around a joint or a fixed point; the totality of movement a joint is capable of doing. A range of motion test, also called a flexibility test, is used to measure the degree of movement of a joint. A goniometer is an instrument that is used to measure the range of motion of a joint.	12 weeks post-operation

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Nicole Zelenski, MD, Assistant professor; Principal Investigator: Eric R Wagner, MD, Assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Arthroscopy; Open surgery; Carpus
• Other Study ID Numbers: STUDY00005088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No