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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-19

Study Completion Date

2019-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures

NCT02030496

Displaced Extra-articular Distal Radius Fractures

COMPLETED NA

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

NCT02660515

Distal Radius Fracture

COMPLETED NA

Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

NCT03009890

Radius Distal Fracture

COMPLETED NA

Evaluating the Utility of Bone Grafts in Open Wedge Corrective Osteotomy and Plate Fixation

NCT06093763

Malunion of Fracture of Radius

RECRUITING NA

Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures

NCT00524719

Distal Radius Fractures

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Distal radius fractures account for 17% of all fractures diagnosed. Two third of those fractures are displaced and need to be reduced.

According to the Dutch National Guidelines, displaced distal radius fractures, after adequate reduction confirmed on X-ray, are best treated nonoperatively with cast immobilization. Moreover, the AAOS Clinical Practice Guideline only suggest surgical fixation when the articular step, after reduction, exceeds 2mm. However, both recommendations are based on studies who did not differentiate between intra- and extra-articular distal radius fractures. So, no clear consensus about the best treatment for patients with displaced intra-articular distal radius fractures can be made. Despite this lack of consensus and the lack of available literature on comparative data to guide treatment for this patient population, a rise in use of volar plating has been observed.

The goal of open reduction and plate fixation is to restore articular congruity and axial alignment, and to enable early post-operative movement. Several studies show good radiological and functional results using the volar locking plate in unstable displaced distal radius fractures.

No studies have been carried out to assess whether operative treatment with plate fixation is superior in displaced complete articular distal radius fractures to nonoperative treatment in patients with these fracture type. Therefore, with this randomized controlled trial the investigators wish to determine the difference in functional outcome, assessed with the Patient Related Wrist Evaluation (PRWE), after open reduction and plate fixation compared to nonoperative treatment with closed reduction and cast immobilization.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Displaced Complete Articular Distal Radius Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Closed reduction and plasterimmobilisation

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.

Group Type ACTIVE_COMPARATOR

Closed reduction and plasterimmobilisation

Intervention Type OTHER

Open reduction and internal plate fixation

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.

Group Type OTHER

Open reduction and internal plate fixation

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open reduction and internal plate fixation

Intervention Type PROCEDURE

Closed reduction and plasterimmobilisation

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ORIF Surgical treatment Cast Conservative treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes