Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

Wrist Injuries Clinical Trial

— WRIST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02911610
• Other study ID #: 16.206_BS
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 29, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 186
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wrist Injuries

Intervention

Device:
• arthroscopy + volar plate
surgery of wrist fractures with volar plate and added arthroscopy
• Volar plate
surgery of wrist fractures with volar plate

Locations

Country	Name	City	State
Spain	Hospital Clinico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-rated Wrist Evaluation (PRWE) questionary score		12 months after intervention