Internal Plate Fixation vs. Plaster in Complete Articular Distal Radial Fractures

NCT02651779 | Completed

• 1 other identifier: NL51544.018.14
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

There is no consensus about the best treatment for patients with displaced complete articular distal radius fractures (AO type C fractures). Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, operative treatment with plate fixation has gained popularity. The aim of this study is to compare the functional outcome of open reduction and plate fixation with closed reduction and plaster immobilisation in adult patients (18-75 years) with displaced complete articular distal radius fractures.

Conditions

Displaced Complete Articular Distal Radius Fractures

Outcome Measures

Primary Outcomes (1)

• Wrist pain and disability measured with the Patient Rated Wrist Evaluation (PRWE)

  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.

  12 months

Secondary Outcomes (8)

• Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (DASH) questionnaire

  6 weeks and 3, 6 and 12 months

• Quality of life measured with the SF-36

  6 weeks and 3, 6 and 12 months

• Pain measured with the Visual Analogue Scale (VAS)

  1, 3 and 6 weeks and 3, 6 and 12 months

• Range of motion measured with a goniometer

  6 weeks and 3, 6 and 12 months

• Grip strength measured with a dynamometer

  6 weeks and 3, 6 and 12 months

Study Arms (2)

Closed reduction and plasterimmobilisation

ACTIVE COMPARATOR

The control group will be treated with closed reduction and cast immobilization. This will take place under local anaesthesia by means of a haematoma block with 20 cc Lidocaine 1%. Closed reduction will be preferably performed according to the Robert-Jones method. This involves increasing the deformity first, then applying continuous traction and immobilizing wrist and hand in the reduced position. Additional radiographs will be performed to verify the success of the reduction. After this has been confirmed, the wrist will be immobilized initially in a split plaster and later changed into a circular cast for five to six weeks immobilization in total.

Other: Closed reduction and plasterimmobilisation

Open reduction and internal plate fixation

OTHER

The surgery will be performed by a certified trauma surgeon. According to the current standard treatment protocol, antibiotic prophylaxis 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 muscle and the radial artery. After the fracture site is exposed, the fracture will be reduced and provisionally fixed under fluoroscopy with K-Wires/reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type will be selected. Fracture reduction and screw placement will be confirmed by radiographic images. Additionally, fixation can be supported by a dorsal plate or radial column plate. This will be at discretion of the surgeon and depends on the fracture configuration and the position of the fragments. Wound closure will be performed at the discretion of the surgeon using standard techniques.

Procedure: Open reduction and internal plate fixation

Interventions

Open reduction and internal plate fixation PROCEDURE

Also known as: ORIF, Surgical treatment

Open reduction and internal plate fixation

Closed reduction and plasterimmobilisation OTHER

Also known as: Cast, Conservative treatment

Closed reduction and plasterimmobilisation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from 18 - 75 years
• AO type C displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs/CT-scan by a radiologist or trauma surgeon
• Acceptable closed reduction obtained immediately after admission to the Emergency Department (\<12hrs)

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Dijklander Ziekenhuis: collaborator
• Maasstad Hospital: collaborator
• Maxima Medical Center: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Rijnland Hospital: collaborator
• Diakonessenhuis, Utrecht: collaborator
• BovenIJ Hospital: collaborator
• Onze Lieve Vrouwe Gasthuis: collaborator
• Groene Hart Ziekenhuis: collaborator
• Reinier de Graaf Groep: collaborator
• Flevoziekenhuis: collaborator
• Ziekenhuis Rivierenland: collaborator
• Radboud University Medical Center: collaborator
• Ziekenhuis Amstelland: collaborator
• Medical Center Alkmaar: collaborator
• Red Cross Hospital Beverwijk: collaborator
• Zaans Medical Center: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, Netherlands

Location

Related Publications (1)

• Mulders MAM, Walenkamp MMJ, Goslings JC, Schep NWL. Internal plate fixation versus plaster in displaced complete articular distal radius fractures, a randomised controlled trial. BMC Musculoskelet Disord. 2016 Feb 9;17:68. doi: 10.1186/s12891-016-0925-y.

  PMID: 26860090 DERIVED

MeSH Terms

Interventions

Open Fracture Reduction; Surgical Procedures, Operative; POLR1G protein, human; Conservative Treatment

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics

Study Officials

• J. Carel Goslings, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Niels W.L. Schep, MD, PhD, MSc

  Maasstad Hospital

  PRINCIPAL INVESTIGATOR

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: Prof. dr.

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 11, 2016
• Study Start: June 19, 2015
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

NL (1)