Operative Treatment of Intra-Articular Distal Radius Fractures With Versus Without Wrist Arthroscopy

Distal Radius Fracture Clinical Trial

— RADAR  

Official title:

Operative Treatment of Intra-Articular Distal Radius Fractures With Versus Without Wrist Arthroscopy, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02660515
• Other study ID #: NL54377.101.15
• Status: Completed
• Phase: N/A
• Start date: February 2, 2016
• Est. completion date: October 26, 2018

Study information

• Verified date: March 2019
• Source: Maasstad Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open reduction and internal fixation of intra-articular distal radius fractures leads to better functional outcomes the first 6 months compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist post-operatively. Arthroscopically assisted removal of intra- articular fracture haematoma and debris may reduce pain and improve the functional outcomes following operative treatment of intra-articular distal radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence of associated ligamentous injuries can be assessed. Therefore the objective of this study is to compare the functional outcome of internal plate fixation with additional wrist arthroscopy versus conventional fluoroscopic assisted internal plate fixation in adult patients with displaced intra-articular distal radius fractures.

Description:

Distal radius fractures account for 17% of all fractures seen at the emergency department. Fifty percent of these fractures are intra-articular. The past several years an increase in open reposition internal fixation (ORIF) for distal radius fractures has been observed. This technique leads to a quicker resume of function the first 3 to 6 months compared to non-operative treatment. However, some patients continue to have a painful and stiff wrist postoperatively. Arthroscopically assisted removal of intra-articular fracture haematoma and debris may improve the functional outcomes following operative treatment of intra-articular distal radius fractures. Moreover, during arthroscopy the quality of the reduction and the presence of associated ligamentous injuries can be assessed.

To our knowledge, no studies have been carried out to further examine the use of arthroscopy after internal plate fixation to remove fracture haematoma and debris on functional outcomes. Therefore, the purpose of this randomised controlled trial is to determine the difference in functional outcome, assessed with the Patient-Rated Wrist Evaluation (PRWE) score, after internal plate fixation with an additional wrist arthroscopy and conventional fluoroscopically assisted internal plate fixation in adult patients with displaced complete articular distal radius fractures. Secondary, we aim to determine the difference in functional outcomes with the Disability of the Arm, Shoulder and Hand (DASH) score, post-operative pain, range of motion, grip strength, complications, quality of life (SF-36), and cost-effectiveness. Additionally, for patients undergoing additional wrist arthroscopy the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 26, 2018
• Est. primary completion date: January 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients =18 years

• Displaced intra-articular distal radius fracture (AO/OTA type C) as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon

• Inacceptable closed reduction requiring open reduction and internal fixation

Exclusion Criteria:

• Dorsal plate fixation in case the radiocarpal joint needs to be opened

• Patients with impaired wrist function prior to injury due to arthrosis/neurological disorders of the upper limb

• Open distal radius fractures

• Multiple trauma patients (Injury Severity Score (ISS) =16)

• Other fractures of the affected extremity (except from ulnar styloid process)

• Fracture of other wrist

• Insufficient comprehension of the Dutch language to understand a rehabilitation program and other treatment information as judged by the attending physician

• Patient suffering from disorders of bone metabolism other than osteoporosis (i.e. Paget's disease, renal osteodystrophy, osteomalacia)

• Patients suffering from connective tissue disease or (joint) hyperflexibility disorders such as Marfan's, Ehler Danlos or other related disorders

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Additional wrist arthroscopy

• ORIF

Locations

Country	Name	City	State
Netherlands	Maasstad Hospital	Rotterdam	Nederland

Sponsors (3)

Lead Sponsor	Collaborator
Maasstad Hospital	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Rated Wrist Evaluation	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.	3 months
Secondary	Disability of the Arm, Shoulder and Hand Disability of the Arm, Shoulder and Hand	The Disabilities of the Arm, Shoulder and Hand (DASH) score is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.	3 and 6 weeks, and 3, 6 and 12 months
Secondary	Pain	Pain as indicated on a visual Analogue Scale (VAS), in which 0 implies no pain and 10 the worst possible pain. Patients will be asked to give an estimation of the type and quantity of pain medication taken during all follow-up visits.	1 day post-operative and 1, 3 and 6 weeks and 3 months
Secondary	Range of motion	Range of motion of the wrist measured on both sides with a handheld goniometer.	3 and 6 weeks and 3 months
Secondary	Grip strength	Grip strength as measured with a dynamometer.	3 and 6 weeks and 3 months
Secondary	Complications	Complication rate such as: wound and/or plate infection, tendon irritation and/or rupture, neuropathy and the occurrence of complex regional pain syndrome.	1 day post-operative and 1, 3 and 6 weeks and 3 months
Secondary	Cost-effectiveness	Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.; Cost-effectiveness and cost-utility measured with an economic evaluation questionnaire based on the EQ-6D and the Standard Form Health and Labour questionnaire.	3 and 6 weeks and 3 months
Secondary	Associated injuries	In the intervention group the quality of reduction, associated ligamentous injuries and cartilage damage will be assessed. Ligamentous injuries are divided in TFCC injuries, classified according to the Palmer classification and scapholunate ligament and lunotruquetral injuries, graded according to the Geissler classification.	Peroperative
Secondary	Patient Rated Wrist Evaluation	The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of three subscales: Pain, Function and Cosmetics.	3 and 6 weeks, and 6 and 12 months