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Spanning Bridged Plate in Comminuted Distal Radius Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04100317
Recruitment Status : Not yet recruiting
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):
Anass Abdeslam kabbour Hanzaz, Assiut University

Tracking Information
First Submitted Date September 20, 2019
First Posted Date September 24, 2019
Last Update Posted Date September 24, 2019
Estimated Study Start Date September 20, 2019
Estimated Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2019)
Wrist range of movement [ Time Frame: Baseline ]
Degree measurment of wrist Flexion. Extension radial and ulnur deviatin
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 20, 2019)
  • Radilogical parameters [ Time Frame: Baseline ]
    By taking new xrays and exactly calculate the distal radius angels and parameters by calculate the exact deviatin
  • Grip strength [ Time Frame: Baseline ]
    By using grip strength power
  • Union [ Time Frame: Baseline ]
    Assesment of union condition by Dexa scan
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Spanning Bridged Plate in Comminuted Distal Radius Fractures
Official Title Result of Spanning Bridge Plate Fixation for Comminuted Intra Articular Distal Radial Fractures.
Brief Summary This study To evaluate the result of using spanning bridge plate in comminuted distal radius fractures.
Detailed Description Distal radius fractures are the most common long bone fracture and the incidence appears to be increasing worldwide. They have been found to account for approximately 17% of all fracture-related emergency department visits. These types of injuries have a bimodal age distribution. The first peak represents young patients involved in high energy traumas, and the second peak represents elderly patients with lower to moderate energy injuries secondary to osteoporosis.Surgical treatment for distal radius fractures varies, as there are numerous techniques for fixation. The goals of fixation are anatomic reduction and stability, as this has been shown to result in improved chances for functional recovery . The use of volar locking plateshas become the standard for treatment of the majority of distal radius fractures requiring surgery . However, adequate fixation for high energy comminuted fractures with or without metadia-physeal extension remains a major treatment challenge. Severely comminuted articular fractures are technically challenging in terms of obtaining an adequate reduction and achieving stabilization with a standard periarticular volar plating technique. The small fracture fragments are often not able to be stabilized with the screws from the volar plate, and the proximally-oriented tension from the forearm musculature acts to pull on the carpus causing further collapse of the articular surface. As an alternate to the volar plate, these types of injuries have been historically treated with an external fixator with or without Kirschner wires. However, it has been reported that highly comminuted distal radius fractures are associated with a 52%-63% complication rate when treated with external fixation . Therefore, despite poor fixation capabilities withthese fracturetypes,thevolarplate remainsthego-to devicefor most surgeons when faced with comminuted articular distal radial fractures. In these circumstances, the dorsal distraction plate (also called dorsal "bridge" plating technique) can serve as an improved fixation technique by allowing comminuted articular fragments to reduce under ligamentotaxis and provide a buttress for the dorsal cortex of the distal radius. In addition, a long dorsal plate can bridge past metaphyseal comminution, which cannot be so easily addressed with standard volar plating . The bridge plate can also be left in place for an extended period of time without the risk of the aforementioned complications of prolonged external fixation use . Finally, the dorsal distraction plate is technically a much easier operation to perform than volar plating for complex articular fractures. Recently, there has been increased use of dorsal distraction plating for these types of injuries .
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Troumatized population with age 18 to 60 years old with comminuted intra articular distal radius fractures.
Condition Distal Radius Fracture
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 20, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 20, 2020
Estimated Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • age 18-60 years old
  • early trouma (within two weeks)

Exclusion Criteria:

  • open fractures
  • concomitant limb injuries
  • old fractures more than two weeks
  • sever osteoporosis and osteopenia.
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contact: Anass Dr Hanzaz, Master +201026081677
Contact: Mohamed Dr Morsy, Proffissor +201099021770
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT04100317
Other Study ID Numbers Bpf in distal radius fractures
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Anass Abdeslam kabbour Hanzaz, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Study Director: Amr Pr Elsayed Proffissor
PRS Account Assiut University
Verification Date September 2019