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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether open or arthroscopic surgery is more effective for fixing perilunate injuries. These wrist injuries can cause long-term issues like pain and weakness if not treated properly. The study compares the outcomes of these two surgical methods to determine which provides better results. Individuals needing surgery for a perilunate injury and eligible to choose between these methods may be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to valuable research that could enhance future treatment options.

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 prior data suggests that these surgical approaches are safe for treating perilunate injuries?

A previous study compared two types of surgery for wrist injuries and found both methods well-tolerated by patients. For the less invasive arthroscopic surgery, research shows a 15% chance of complications, with the most common issue being the bone not staying in place after surgery, occurring in about 10% of cases. Despite this, patients usually regain good function and experience low pain over time.

For the more traditional open surgery, studies on similar surgeries suggest it often leads to faster recovery and shorter hospital stays. However, open surgery can carry a higher risk of infection compared to less invasive methods. Both approaches are standard and widely used, indicating they are generally safe for treating these injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to compare two well-established surgical techniques—open and arthroscopic surgery—for treating perilunate injuries. While both methods are standard procedures, the trial seeks to determine which approach offers better outcomes in terms of recovery time, pain management, and long-term functionality. By directly comparing these techniques, the trial could provide valuable insights that help surgeons choose the most effective treatment method for their patients, potentially improving recovery experiences and overall results.

What evidence suggests that this trial's treatments could be effective for perilunate injuries?

This trial will compare open surgery and arthroscopic surgery for perilunate injuries. Research has shown that arthroscopic surgery can provide results similar to open surgery. One study comparing these methods found that both have similar outcomes in the short and long term. Participants in this trial may receive arthroscopic surgery, which has been associated with high satisfaction, good function, and low pain over time. Alternatively, participants may receive open surgery, a well-known method that effectively treats these injuries but may cause more tissue damage. Both surgeries can fix the injury, but arthroscopic surgery might cause less harm to surrounding tissues. Overall, both options work well, and the choice may depend on each patient's needs and preferences. ^{1 2 6 7 8}

Who Is on the Research Team?

Nicole Zelenski, MD

Principal Investigator

Assistant Professor

Eric R Wagner, MD

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

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

I am over 18 years old and not pregnant.

Prisoners will not be included in this study

I do not need a specific surgery for my condition.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40219854/

Arthroscopic versus open surgery in perilunate injuries This retrospective case-control study compares arthroscopic surgery (AS) with open reduction and internal fixation (ORIF) in early and late follow-up outcomes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12456979/

Medium-Term Patient-Reported Outcomes after Surgical ... Patients had an average satisfaction of 6.6/10, and the average PRWE score was 36.0 at the final follow-up ( Table 4 ). PRWE pain and function ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212628724005103

Arthroscopic Assisted Reduction and Percutaneous ... Managing acute perilunate injuries (APLI) presents significant challenges due to the complex anatomy and technical intricacies involved.

4. researchgate.net researchgate.net/publication/388873712_Outcomes_after_Acute_Perilunate_Injuries_A_Single-Center_Experience_Over_30_Years

Outcomes after Acute Perilunate Injuries: A Single-Center ... Conclusions Overall, patients retain a relatively high level of function and report low pain scores long-term after perilunate injuries. Multi- ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05748-1

Long-term results of trans-scaphoid perilunate fracture ... The modified Mayo wrist score evaluation scale considered 12 cases as excellent, and 10 good. The median of VAS and Krimmer scores at the final ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36750472/

Outcomes of acute perilunate injuries-a systematic review The overall postoperative complication rate was 15.0% with secondary reduction loss representing the main contributing factor (10.1%).

7. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/a-2500-9895

Outcomes after Acute Perilunate Injuries - Thieme Connect Conclusions Overall, patients retain a relatively high level of function and report low pain scores long-term after perilunate injuries. Multi-centre, ...

8. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(11)01044-9/abstract

Arthroscopic Reduction and Percutaneous Fixation of ... According to modified Mayo wrist scores, overall functional outcomes were rated as excellent in 3 patients, good in 8, fair in 7, and poor in 2. Nonunion ...