Assessment of Arthroscopy in Patients Undergoing Wrist Fracture

NCT ID: NCT02911610

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-29
• Study Completion Date: 2022-12-31

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.

Conditions

Wrist Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arthroscopy + volar plate

surgery of wrist fractures with volar plate and added arthroscopy

Group Type: EXPERIMENTAL

arthroscopy + volar plate

Intervention Type: DEVICE

surgery of wrist fractures with volar plate and added arthroscopy

volar plate

surgery of wrist fractures with volar plate

Group Type: OTHER

Volar plate

Intervention Type: DEVICE

surgery of wrist fractures with volar plate

Interventions

arthroscopy + volar plate

surgery of wrist fractures with volar plate and added arthroscopy

Intervention Type: DEVICE

Volar plate

surgery of wrist fractures with volar plate

Intervention Type: DEVICE

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: lead

Responsible Party

Mª José Perez Úbeda

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinico San Carlos

Madrid, , Spain

Countries

Spain

Other Identifiers

16.206_BS

Identifier Type: -

Identifier Source: org_study_id