Clinical trial NCT02660515: Operative Treatment of Intra-Articular Distal Radius Fractures With Versus Without Wrist Arthroscopy
Official title: Operative Treatment of Intra-Articular Distal Radius Fractures With Versus Without Wrist Arthroscopy, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: complete articular distal radius fracture
wrist arthroscopy
Lead sponsor: Maasstad Hospital
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2016-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Rated Wrist Evaluation
timeFrame: 3 months
Secondary outcomes:
measure: Disability of the Arm, Shoulder and Hand Disability of the Arm, Shoulder and Hand
timeFrame: 3 and 6 weeks, and 3, 6 and 12 months
measure: Pain
timeFrame: 1 day post-operative and 1, 3 and 6 weeks and 3 months
measure: Range of motion
timeFrame: 3 and 6 weeks and 3 months
measure: Grip strength
timeFrame: 3 and 6 weeks and 3 months
measure: Complications
timeFrame: 1 day post-operative and 1, 3 and 6 weeks and 3 months
measure: Cost-effectiveness
timeFrame: 3 and 6 weeks and 3 months
measure: Associated injuries
timeFrame: Peroperative
measure: Patient Rated Wrist Evaluation
timeFrame: 3 and 6 weeks, and 6 and 12 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Nederland
Study officials:
References:
citation: Mulders MAM, Selles CA, Colaris JW, Peters RW, van Heijl M, Cleffken BI, Schep NWL. Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial. Trials. 2018 Feb 2;19(1):84. doi: 10.1186/s13063-017-2409-2.