Perilunate Management

Not Applicable

Recruiting

• Conditions: Perilunate Injury
• Interventions: Procedure: Open Surgery; Procedure: Arthroscopic surgery

• Registration Number: NCT05824078
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-21
• Study Start: 2023-07-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open procedure	Open Surgery	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.
Arthroscopic Procedure	Arthroscopic surgery	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.

Primary Outcome Measures

Name	Time	Method
Pain Numeric Rating Scale (NRS)	12 weeks post-operation	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.

Secondary Outcome Measures

Name	Time	Method
Range of motion	12 weeks post-operation	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.

Trial Locations

Locations (1)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States