Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

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.

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Key information

Conditions

Wrist Injuries Arm Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

arthroscopy + volar plate

Device

surgery of wrist fractures with volar plate and added arthroscopy

Volar Plate

Device

surgery of wrist fractures with volar plate

Primary outcomes

Patient-rated Wrist Evaluation (PRWE) questionary score

Time frame: 12 months after intervention

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

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

Acronym: WRIST

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Sep 22, 2016
Registry last updated: Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed