Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures
NCT ID: NCT05580848
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2022-11-20
2024-09-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Examined group
28 patients with indication for distal radius fracture (DRF) osteosynthesis : 14 patients with extraarticular DRF and 14 patients with intraarticular DRF with associated wrist arthroscopy
Wrist arthroscopy
Wrist arthroscopy is a minimally invasive endoscopic method that enables the diagnosis and treatment of certain diseases and injuries of the radiocarpal, mediocarpal and distal radioulnar joints.
Wrist arthroscopy enables a direct view of the articular surface of the wrist and the assessment and adequate treatment of articular fractures The wrist arthroscopy procedure also enables the detection and necessary treatment of associated soft tissue injuries (scapho-lunate and/or luno-triquetral ligament, i.e. triangular fibrocartilaginous complex) and/or cartilage lesions in extra-articular and articular fractures.
Control group
28 patients with indication for distal radius fracture (DRF) osteosynthesis : 14 patients with extraarticular DRF and 14 patients with intraarticular DRF without associated wrist arthroscopy.
No interventions assigned to this group
Interventions
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Wrist arthroscopy
Wrist arthroscopy is a minimally invasive endoscopic method that enables the diagnosis and treatment of certain diseases and injuries of the radiocarpal, mediocarpal and distal radioulnar joints.
Wrist arthroscopy enables a direct view of the articular surface of the wrist and the assessment and adequate treatment of articular fractures The wrist arthroscopy procedure also enables the detection and necessary treatment of associated soft tissue injuries (scapho-lunate and/or luno-triquetral ligament, i.e. triangular fibrocartilaginous complex) and/or cartilage lesions in extra-articular and articular fractures.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* DRF that do not have an indication for surgical treatment,
* Refusal to participate in the research,
* Inability to decide independently about participation in the research (persons under guardianship),
* Open fractures,
* Presence of severe soft tissue injuries,
* Infections,
* Poor general condition of patients and internal medicine contraindications.
50 Years
69 Years
FEMALE
No
Sponsors
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University of Rijeka, The Faculty of Medicine
UNKNOWN
Clinic for Orthopedics Lovran
OTHER
Responsible Party
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Borjan Josifovski
Principal Investigator
Central Contacts
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References
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Other Identifiers
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ClinicOL
Identifier Type: -
Identifier Source: org_study_id
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