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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Numeric Rating Scale (NRS)
Secondary outcome measures
Range of motion
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
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,645 Total Patients Enrolled
Nicole Zelenski, MDPrincipal InvestigatorAssistant Professor
1 Previous Clinical Trials
80 Total Patients Enrolled
Eric R Wagner, MDPrincipal InvestigatorAssistant Professor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I need surgery for a wrist injury and will be assigned a surgical method.I am over 18 years old and not pregnant.I do not need a specific surgery for my condition.I am an adult, mentally capable, and make decisions freely.
Research Study Groups:
This trial has the following groups:- Group 1: Open procedure
- Group 2: Arthroscopic Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still an opportunity to enroll in this research endeavor?
"Records on clinicaltrials.gov indicate that this research endeavor is no longer enrolling patients; the trial was inaugurated April 1st 2023 and last updated 11 days later. However, there are currently one additional studies actively recruiting participants."
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