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Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

NCT02911610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-10-22

No results posted yet for this study

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

DEVICE

arthroscopy + volar plate

surgery of wrist fractures with volar plate and added arthroscopy

DEVICE

Volar plate

surgery of wrist fractures with volar plate

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02911610 on ClinicalTrials.gov