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Open vs Arthroscopic Surgery for Perilunate Injury

N/A

Recruiting

Led By Nicole Zelenski, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks post-operation

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at if open or arthroscopic surgery is better for treating debilitating injuries of the carpus (perilunate injuries), and the risks/benefits of each.

Who is the study for?

This trial is for adults over 18 with perilunate injuries needing surgery. Participants will be randomly assigned to receive either open or arthroscopic surgery. Excluded are prisoners, pregnant women, minors, cognitively impaired individuals, and those who can't be randomly assigned due to specific surgical needs.

What is being tested?

The study compares two types of surgeries for perilunate injuries: open and arthroscopic. It aims to identify the differences in outcomes between these approaches which both have their own benefits and risks.

What are the potential side effects?

Potential side effects may include nerve damage leading to weakness or chronic pain, misalignment during healing post-surgery, as well as general risks associated with surgical procedures such as infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post-operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Numeric Rating Scale (NRS)

Secondary study objectives

Range of motion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Open procedureActive Control1 Intervention

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 II: Arthroscopic ProcedureActive Control1 Intervention

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