Clinical trial NCT05824078: Perilunate Management
Official title: Outcomes of Perilunate Injury Management: Open vs Arthroscopic Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perilunate Injury
Keywords: Carpus
Arthroscopy
Open surgery
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain Numeric Rating Scale (NRS)
timeFrame: 12 weeks post-operation
Secondary outcomes:
measure: Range of motion
timeFrame: 12 weeks post-operation
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Assistant Professor
name: Nicole Zelenski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor
name: Eric R Wagner, MD
role: PRINCIPAL_INVESTIGATOR
References: