NCT02911610

Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

Open and Controlled Trial to Assess the Arthroscopy Use in Patients Undergoing Wrist Fracture Surgery by Volar Plate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The use of arthroscopy with the surgery of wrist fractures has a great health and economic impact (prolongs the time of surgery, requires adequately trained personnel, increases the time and surgical expenses and the risk of complications, however, in return ameliorate the prognosis and improves the functional recovery). There are few clinical trials showing a sufficient level of evidence in comparing the results of the surgical treatment of these fractures with volar plate and added arthroscopy so it is necessary to perform a clinical trial with an appropriate design and a sufficient sample size to elucidate the usefulness of arthroscopy in wrist fractures. Therefore, the investigators want to perform an open and controlled clinical trial to adequately analyze the role of arthroscopy in the surgical treatment of wrist fractures in the investigators hospitals. The main objective of the study is to probe the arthroscopy effectiveness in the functionality of the injured wrist by PRWE (a questionnaire assessing pain and wrist function) between the treatment groups of the trial at 12 months after surgery and for this the investigators plan a phase IV multicenter clinical trial.

Conditions

• Wrist Injuries

Interventions

Type	Name	Description
DEVICE	arthroscopy + volar plate	surgery of wrist fractures with volar plate and added arthroscopy
DEVICE	Volar plate	surgery of wrist fractures with volar plate

Timeline

• Start date: 2017-08-29
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2016-09-22
• Last updated: 2024-10-22

Locations

1 site across 1 country: Spain