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Trial record 17 of 57 for:    Recruiting, Not yet recruiting, Available Studies | Arthroscopy

Assessment of Arthroscopy in Patients Undergoing Wrist Fracture (WRIST)

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ClinicalTrials.gov Identifier: NCT02911610
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Mª José Perez Úbeda, Hospital San Carlos, Madrid

Brief 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.


Condition or disease Intervention/treatment Phase
Wrist Injuries Device: arthroscopy + volar plate Device: Volar plate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Open and Controlled Trial to Assess the Arthroscopy Use in Patients Undergoing Wrist Fracture Surgery by Volar Plate
Actual Study Start Date : August 29, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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

volar plate
surgery of wrist fractures with volar plate
Device: Volar plate
surgery of wrist fractures with volar plate




Primary Outcome Measures :
  1. Patient-rated Wrist Evaluation (PRWE) questionary score [ Time Frame: 12 months after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911610


Contacts
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Contact: Maria Jose Perez Ubeda 913003000 mpubeda@salud.madrid.org

Locations
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Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Maria Jose Perez Ubeda       mpubeda@salud.madrid.org   
Sponsors and Collaborators
Hospital San Carlos, Madrid

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Responsible Party: Mª José Perez Úbeda, MD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT02911610     History of Changes
Other Study ID Numbers: 16.206_BS
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wrist Injuries
Arm Injuries
Wounds and Injuries