Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures

Not Applicable

Not yet recruiting

• Conditions: Radius Fracture Distal; Fracture
• Interventions: Procedure: Wrist arthroscopy

• Registration Number: NCT05580848
• Lead Sponsor: Clinic for Orthopedics Lovran

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-01
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Last Update Submitted: 2022-10-16
• Last Update Posted: 2022-10-18
• Study Start: 2022-11-20
• Primary Completion: 2023-12-20
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Examined group	Wrist arthroscopy	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

Primary Outcome Measures

Name	Time	Method
DASH Score	6 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
VAS	6 months after surgery.	The visual analogue scale (VAS) of pain will be used in this study as a tool to assess the clinical outcome of treatment. It consists of the length of a solid line with values at the beginning and end of the line from 0 to 10 cm (0 - 100 mm). The leftmost side means the absence of pain, and the rightmost side means unbearable pain.
MWS	6 months after surgery.	The Mayo Wrist Score (MWS) will be evaluated through 4 questions: (1) pain intensity, (2) functional status - ability to return to regular work, (3) active range of motion of bending /extension of the affected wrist compared to the contralateral side (5 answers offered to be scored from 0 to 25 points) and (4) grip strength of the affected hand compared to the contralateral side (5 answers offered to be scored from 0 to 25 points). The possible score ranges from 0 to 100 points. Interpretation of the results: from 90-100 points is an excellent result, 80-90 points is a good result, 60-80 points is a satisfactory result, and below 60 points is a bad result.
PRWE	6 months after surgery.	The Patient-Rated Wrist Evaluation (PRWE) score is a highly reliable and valid 15-question questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to assess their own level of pain and disability in the wrist from 0 to 10, and consists of 2 parts: pain and function. The part about pain contains 5 questions, the maximum score in this part is 50, and the minimum is 0. The part about function contains 10 questions divided into 2 parts, i.e. specific activities (6 questions) and usual activities (4 questions). The maximum score in this part is 50, and the minimum is 0.