Assessment of Arthroscopy in Patients Undergoing Wrist Fracture (WRIST)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wrist Injuries
• Intervention / Treatment: Device: arthroscopy + volar plate; Device: Volar plate

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent
• Patients able to read and understand the same consent.
• Patients over 18 years

• Broken wrist surgery with criteria based on the following criteria (must meet all):

  • Patients functionally independent, ie, they can make the purchase without help, categorized according Mackenney or patients who require assisted support by crutches / walker for walking.

  • Radiographic unacceptable reduction after 1 attempted closed reduction in the ER, defined as:

    1. dorsal angulation> 0 °
    2. ulnar variance> 3mm postreduction.
    3. Step articular> 1mm (20)
    4. radial inclination <15 °
  • Patients with unstable fracture.

Exclusion Criteria:

• Type III open fractures of Gustilo and Anderson.
• Bilateral fractures (not acceptable include more than one doll per patient for the analysis of the variables in the study, always choosing the wrist of the dominant hand).
• Fractures associated ipsilateral upper limb affection (except distal ulnar fracture).
• Fracture or serious injury prior ipsilateral wrist.
• Medical criteria that contraindicate surgery.
• Patients with low functional demand, categorized as dependent as Mackenney, ie, they need help to go shopping and do not require assisted support by crutches / walker for walking.
• Patients with tumor lesions secondary processes (eg osteosarcoma, prostate cancer, breast cancer, multiple myeloma), congenital metabolic (eg osteogenesis imperfecta) and others involving themselves poor prognosis associated with disease.
• Women with suspected pregnancy or pregnancy can not participate in this clinical trial because the collection of monitoring data is expected performing radiographic examinations, in case of pregnancy, would be contraindicated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arthroscopy + volar plate; surgery of wrist fractures with volar plate and added arthroscopy	Device: arthroscopy + volar plate; surgery of wrist fractures with volar plate and added arthroscopy
OTHER: volar plate; surgery of wrist fractures with volar plate	Device: Volar plate; surgery of wrist fractures with volar plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient-rated Wrist Evaluation (PRWE) questionary score	12 months after intervention

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 29, 2017
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (ESTIMATE): September 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Wrist Injuries
• Other Study ID Numbers: 16.206_BS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No