NCT02660515

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

February 2, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

January 13, 2016

Last Update Submit

March 7, 2019

Conditions

Distal Radius Fracture

Keywords

complete articular distal radius fracturewrist arthroscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Disability of the Arm, Shoulder and Hand Disability of the Arm, Shoulder and Hand

    3 and 6 weeks, and 3, 6 and 12 months

  • Pain

    1 day post-operative and 1, 3 and 6 weeks and 3 months

  • Range of motion

    3 and 6 weeks and 3 months

  • Grip strength

    3 and 6 weeks and 3 months

  • Complications

    1 day post-operative and 1, 3 and 6 weeks and 3 months

  • +3 more secondary outcomes

Study Arms (2)

ORIF

ACTIVE COMPARATOR

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.

Procedure: ORIF

ORIF with additional wrist arthroscopy

ACTIVE COMPARATOR

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.

Procedure: Additional wrist arthroscopyProcedure: ORIF

Interventions

Additional wrist arthroscopyPROCEDURE
ORIF with additional wrist arthroscopy
ORIFPROCEDURE
Also known as: open reduction and internal fixation
ORIFORIF with additional wrist arthroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maasstad Hospital

Rotterdam, Nederland, 1072 VM, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 29394904DERIVED

MeSH Terms

Conditions

Wrist Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 21, 2016

Study Start

February 2, 2016

Primary Completion

January 18, 2018

Study Completion

October 26, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

NL(1)