Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures

October 16, 2022 updated by: Borjan Josifovski, Clinic for Orthopedics Lovran

Wrist Arthroscopy During Surgical Treatment of Distal Radius Fractures Improves Functional Outcome: a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DASH Score
Time Frame: 3 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.
3 months after surgery
DASH Score
Time Frame: 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.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: 3 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.
3 months after surgery.
VAS
Time Frame: 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.
6 months after surgery.
MWS
Time Frame: 3 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.
3 months after surgery.
MWS
Time Frame: 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.
6 months after surgery.
PRWE
Time Frame: 3 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.
3 months after surgery.
PRWE
Time Frame: 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.
6 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinic for Orthopedics Lovran

Collaborators

University of Rijeka, The Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 20, 2022

Primary Completion (Anticipated)

December 20, 2023

Study Completion (Anticipated)

September 20, 2024

Study Registration Dates

First Submitted

October 1, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 16, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ClinicOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fracture

Clinical Trials on Wrist arthroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe