50 Participants Needed

Open vs Arthroscopic Surgery for Perilunate Injury

NZ
OJ
JB
Overseen ByJasone Barron
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of arthroscopic surgery for perilunate injuries?

Research suggests that arthroscopic surgery for perilunate injuries can achieve similar results to the traditional open surgery, with less tissue damage and potentially better wrist movement and grip strength. This minimally invasive approach may be a reliable option for treating these injuries.12345

Is surgery generally safe for humans?

Research shows that minimally invasive surgeries like laparoscopy are generally safe and often have fewer complications compared to open surgeries, such as laparotomy, especially in treating conditions like endometrial cancer. These techniques are associated with benefits like less blood loss and shorter hospital stays.678910

How does arthroscopic surgery differ from open surgery for perilunate injuries?

Arthroscopic surgery for perilunate injuries is a minimally invasive technique that aims to reduce tissue damage and preserve blood supply compared to open surgery, which can lead to joint stiffness and scarring. This approach uses small incisions and a camera to guide the procedure, potentially offering similar outcomes to open surgery with less recovery time and fewer complications.123411

What is the purpose of this trial?

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.

Research Team

NZ

Nicole Zelenski, MD

Principal Investigator

Assistant Professor

ER

Eric R Wagner, MD

Principal Investigator

Assistant Professor

Eligibility Criteria

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.

Inclusion Criteria

I need surgery for a wrist injury and will be assigned a surgical method.

Exclusion Criteria

Prisoners will not be included in this study
I am over 18 years old and not pregnant.
I do not need a specific surgery for my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either open or arthroscopic surgical intervention for perilunate injuries

1 week
1 visit (in-person for surgery)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of pain and range of motion

12 weeks
Multiple visits (in-person and virtual)

Long-term follow-up

Participants are followed for up to 1 year to assess long-term outcomes and functional healing

1 year

Treatment Details

Interventions

  • Arthroscopic surgery
  • Open Surgery
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

References

The role of arthroscopy for treatment of perilunate injuries. [2020]
Comparative Outcome Analysis of Arthroscopic-Assisted Versus Open Reduction and Fixation of Trans-scaphoid Perilunate Fracture Dislocations. [2018]
Arthroscopic Management of Perilunate Injuries. [2018]
Acute perilunate dislocations. [2016]
Complications and outcomes of operative treatment for acute perilunate injuries: a systematic review. [2023]
Adverse events associated with laparoscopy vs laparotomy in the treatment of endometrial cancer. [2011]
Surgical treatment of endometrial cancer and atypical hyperplasia: a trend shift from laparotomy to laparoscopy. [2021]
Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial. [2022]
Longitudinal perioperative patient-reported outcomes in open compared with minimally invasive hysterectomy. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Hysterectomy for the treatment of gynecologic malignancy. [2014]
Arthroscopic Reduction and Stabilization of Chronic Perilunate Wrist Dislocations. [2020]
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