Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures

Status Not yet recruiting

Clinical Trial Summary

Wrist arthroscopy (WA) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (DRFs). Previous research on the contribution of WA to DRF treatment has shown different results. Objectives of the study: (1) Validate wrist functional outcome questionnaires; (2) To determine whether arthroscopically assisted repositioning of fracture fragments in articular DRFs leads to a better treatment outcome; (3) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in articular DRFs leads to a better treatment outcome; (4) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in extraarticular DRFs leads to a better treatment outcome. Research hypotheses: (1) Validated questionnaires will have satisfactory measurement properties (validity, reliability) and will be able to be used in a WA randomized controlled trial; (2) WA as an adjunct to DRF osteosynthesis improves the clinical outcome of treatment. Subjects: 56 female patients with indication for DRF osteosynthesis aged 50-69 years divided into 2 groups: 1. examined - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) with associated WA, and 2. control - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) without associated WA. Methods: As a primary outcome measure, functional outcomes of treatment will be analyzed with the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 6 months after surgery. As a secondary outcome measures it will be analyzed pain level according to a visual analog scale (VAS), preoperative and postoperative radiographic parameters of distal radius, and clinical outcomes of treatment with the Mayo Wrist Score (MWS) and Patient-Rated Wrist Evaluation (PRWE) score at 3 and 6 months after surgery. Expected scientific contribution: providing answers on the role of WA in the treatment of DRF and associated injuries as well as its impact on treatment outcome.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05580848
Study type	Interventional
Source	Clinic for Orthopedics Lovran
Contact	Borjan Josifovski, MD
Phone	+385911542647
Email	borjan.josifovski@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	November 20, 2022
Completion date	September 20, 2024

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT04470895` - Impact of Drugs on the Risk of Falls in the Fracture Department of the Paris Saint-Joseph Hospital Group
Recruiting	`NCT02635022` - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Unknown status	`NCT02013986` - Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children	Phase 4
Terminated	`NCT01248182` - Bone to Skin Thickness Study: Obese Versus Normal Population	N/A
Recruiting	`NCT00969839` - NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures	Phase 4
Completed	`NCT00520442` - Acute Pediatric Fracture Analgesia Study	N/A
Completed	`NCT00115180` - Racial and Ethnic Disparities in Acute Pain Control	N/A
Not yet recruiting	`NCT06402292` - Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute	N/A
Recruiting	`NCT04947722` - The PREVENT Trial: a Pragmatic Cluster Randomized Controlled Trial of a Multifaceted Fracture Prevention Model for Long-term Care	N/A
Recruiting	`NCT06107699` - The CHARM Study-Coordinating Transitions From Hospital for Older Adults With Fractures	N/A
Completed	`NCT04532580` - Clinical Validation of Boneview for FDA Submission
Completed	`NCT04237454` - Thermal Imaging Compared to Skeletal Survey in Children Below 2 Years	N/A
Recruiting	`NCT05002335` - Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
Completed	`NCT02591043` - Surgical Treatment of Low Energy Pelvic Fractures in the Elderly	N/A
Completed	`NCT02933359` - Osteogenic Profiling of Normal Calvarial Bone
Completed	`NCT01049191` - Bone Microarchitecture in Women With and Without Fracture	N/A
Completed	`NCT03431857` - Multi Centre Study on TESS V2 Shoulder System
Recruiting	`NCT04133103` - Early Mobilisation in the Surgical Robot Assisted Spinal Surgery	N/A
Completed	`NCT03993691` - Wrist Fracture Evaluation With a Desktop Orthopedic Tomosynthesis System	N/A
Active, not recruiting	`NCT01719887` - Effectiveness and Cost-effectiveness of Surgical Treatment of Humeral Shaft Fractures. Randomized Controlled Trial	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.