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Assessment of Arthroscopy in Patients Undergoing Wrist Fracture (WRIST)

Primary Purpose

Wrist Injuries

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
arthroscopy + volar plate
Volar plate
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clinico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arthroscopy + volar plate

volar plate

Arm Description

surgery of wrist fractures with volar plate and added arthroscopy

surgery of wrist fractures with volar plate

Outcomes

Primary Outcome Measures

Patient-rated Wrist Evaluation (PRWE) questionary score

Secondary Outcome Measures

Full Information

First Posted
June 17, 2016
Last Updated
May 3, 2022
Sponsor
Hospital San Carlos, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT02911610
Brief Title
Assessment of Arthroscopy in Patients Undergoing Wrist Fracture
Acronym
WRIST
Official Title
Open and Controlled Trial to Assess the Arthroscopy Use in Patients Undergoing Wrist Fracture Surgery by Volar Plate
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthroscopy + volar plate
Arm Type
Experimental
Arm Description
surgery of wrist fractures with volar plate and added arthroscopy
Arm Title
volar plate
Arm Type
Other
Arm Description
surgery of wrist fractures with volar plate
Intervention Type
Device
Intervention Name(s)
arthroscopy + volar plate
Intervention Description
surgery of wrist fractures with volar plate and added arthroscopy
Intervention Type
Device
Intervention Name(s)
Volar plate
Intervention Description
surgery of wrist fractures with volar plate
Primary Outcome Measure Information:
Title
Patient-rated Wrist Evaluation (PRWE) questionary score
Time Frame
12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: dorsal angulation> 0 ° ulnar variance> 3mm postreduction. Step articular> 1mm (20) 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.
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

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