Open vs Arthroscopic Surgery for Perilunate Injury

Overseen By Jasone Barron

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Prisoners, Minors, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 2 3 4 11}

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

Nicole Zelenski, MD

Principal Investigator

Assistant Professor

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

Group I: Open procedure Active Control 1 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 Procedure Active Control 1 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.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

The role of arthroscopy for treatment of perilunate injuries. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Comparative Outcome Analysis of Arthroscopic-Assisted Versus Open Reduction and Fixation of Trans-scaphoid Perilunate Fracture Dislocations. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Arthroscopic Management of Perilunate Injuries. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Acute perilunate dislocations. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Complications and outcomes of operative treatment for acute perilunate injuries: a systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events associated with laparoscopy vs laparotomy in the treatment of endometrial cancer. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of endometrial cancer and atypical hyperplasia: a trend shift from laparotomy to laparoscopy. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Longitudinal perioperative patient-reported outcomes in open compared with minimally invasive hysterectomy. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Hysterectomy for the treatment of gynecologic malignancy. [2014]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Arthroscopic Reduction and Stabilization of Chronic Perilunate Wrist Dislocations. [2020]