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

NCT ID: NCT02660515

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-02
• Study Completion Date: 2018-10-26

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.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ORIF

The operation has to be performed within 3 weeks after the initial trauma. According to the current standard, antibiotic prophylaxis (Cefazoline, 1000 milligram intravenous) will be administered thirty minutes preoperatively. The distal radius will be approached according to Henry, which beholds an incision between the tendon of the flexor carpi radialis and the arteria radialis. After the fracture site is exposed, the fracture will be reduced and an appropriate volar locking plate will be positioned. The type and brand of the plate are at discretion of the treating surgeon. When a dorsal approach is deemed necessary the distal radius will be approached between the third and fourth dorsal extensor tendon compartments. To evaluate the quality of articular reduction, fluoroscopic images will be obtained. Wound closure will be performed using standard techniques.

Group Type: ACTIVE_COMPARATOR

ORIF

Intervention Type: PROCEDURE

ORIF with additional wrist arthroscopy

Surgery will be performed by a certified trauma surgeon, with experience in wrist arthroscopy. A delay of minimal 5 days before performing arthroscopy is mandatory to enable visualisation due to the organisation of the hematoma. During wrist arthroscopy, the forearm will be positioned upright and in neutral position, the elbow flexed by 90° and axial traction of 4-6 kg will be performed. Four portal entrees are created by superficial stab incisions and blunt preparation through the joint capsule; one midcarpal radiair and one midcarpal ulnar portal and the 3-4 and 6-R portal. A shaver is used for removal of fracture haematoma and osteocartilaginous debris. Cartilage damage will be graded using the Outerbridge classification system. With the 1 mm hook probe assessment of the quality of reduction and ligamentous injuries (TFCC, scapholunate and lunotriquetral) will be performed. Wound closure will be performed using standard techniques.

Group Type: ACTIVE_COMPARATOR

Additional wrist arthroscopy

Intervention Type: PROCEDURE

ORIF

Intervention Type: PROCEDURE

Interventions

Additional wrist arthroscopy

Intervention Type: PROCEDURE

ORIF

Intervention Type: PROCEDURE

Other Intervention Names

open reduction and internal fixation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: collaborator

Maasstad Hospital

OTHER

Sponsor Role: lead

Responsible Party

Niels Schep

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Maasstad Hospital

Rotterdam, Nederland, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 29394904 (View on PubMed)

Other Identifiers

NL54377.101.15

Identifier Type: -

Identifier Source: org_study_id