Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures

NCT05580848 | Unknown

• 1 other identifier: ClinicOL
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fracture; Radius Fracture Distal

Keywords

Arthroscopy; Radius Fractures; Surveys and Questionnaires; Treatment Outcome; Wrist

Outcome Measures

Primary Outcomes (2)

• DASH Score

  Disabilities of the Arm, Shoulder and Hand It consists of 30 questions and is used to assess functional disorders of the upper extremity. 21 questions examine the extent to which the patient had problems performing certain activities during the last week. 6 questions assess specific symptoms (eg, pain, paresthesias, sleep disturbances) during the last week, and 3 questions assess social or occupational limitations during the last week. The possible score ranges from 0 to 100 points. 0 points represents complete, unrestricted function of the upper extremities, while 100 points represents the greatest possible functional impairment.

  3 months after surgery

• DASH Score

  Disabilities of the Arm, Shoulder and Hand It consists of 30 questions and is used to assess functional disorders of the upper extremity. 21 questions examine the extent to which the patient had problems performing certain activities during the last week. 6 questions assess specific symptoms (eg, pain, paresthesias, sleep disturbances) during the last week, and 3 questions assess social or occupational limitations during the last week. The possible score ranges from 0 to 100 points. 0 points represents complete, unrestricted function of the upper extremities, while 100 points represents the greatest possible functional impairment.

  6 months after surgery

Secondary Outcomes (6)

• VAS

  3 months after surgery.

• VAS

  6 months after surgery.

• MWS

  3 months after surgery.

• MWS

  6 months after surgery.

• PRWE

  3 months after surgery.

Study Arms (2)

Examined group

EXPERIMENTAL

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

Procedure: Wrist arthroscopy

Control group

NO INTERVENTION

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.

Interventions

Wrist arthroscopy PROCEDURE

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.

Examined group

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Distal radius fractures with an indication for surgical treatment according to the AO/OTA classification of patients aged 50-69 years who have signed an informed consent to participate in the research.

You may not qualify if:

• Distal radius fractures( DRF) that have an indication for surgical treatment in all patients and in patients younger than 50 and older than 69,
• 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.

Sponsors & Collaborators

• Clinic for Orthopedics Lovran: lead
• University of Rijeka, The Faculty of Medicine: collaborator

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MeSH Terms

Conditions

Fractures, Bone; Wrist Fractures; Radius Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wrist Injuries; Arm Injuries; Forearm Injuries

Central Study Contacts

Borjan Josifovski, MD

CONTACT

+385911542647; borjan.josifovski@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 14, 2022
• Study Start: November 20, 2022
• Primary Completion: December 20, 2023
• Study Completion: September 20, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10