A Phase 4 interventional study of Variable Angle Distal Radius Plate ® (Surgery) in Distal Radius Fractures, sponsored by AO Clinical Investigation and Publishing Documentation. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-09-19.
Sponsored by AO Clinical Investigation and Publishing Documentation · Phase 4, Interventional, and Treatment
The purpose of this study is to is to evaluate the postoperative loss of reduction rate in patients with distal radius fractures treated using the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®.
The treatment of choice for distal radius fractures is anatomic reduction with stable fixation. This is commonly achieved via open reduction and internal fixation with angle-stable designed locking plates using either a volar or dorsal approach. Frequent complications of tendinitis are associated with the latter approach. Palmar application of angle-stable plates reduces this problem of extensor tendon irritation; however a high incidence of fracture collapse has been documented. Currently, there are no existing locking plates that provide sufficient stability particularly for complex fractures. Insufficient fragment fixation can result in loss of reduction due to interfragmentary movement and lead to mal- or nonunion.
The Variable Angle LCP Two-Column Volar DR plate (VA LCP DR) is a novel development of the LCP Distal Radius Plate System, which is designed to treat a wide variety of distal radius fracture patterns. Because of its design (ie, low plate and screw profile, polished surface, rounded edges, various locking options), not only can the potential for tendon adhesions and soft tissue irritation be minimized, the plate can address fragments individually for each fracture type. Thus, the versatility of VA LCP facilitates the reduction and stabilization of even the most complex fractures, including those in osteoporotic bone.
This prospective case-series will evaluate the performance of the new VA LCP DR plate in the treatment of complex articular fractures of the distal radius. The primary objective of this study involves the documentation of postoperative loss of reduction; functional outcomes, quality of life and rate of complications associated with fracture fixation will also be assessed as part of the secondary study aims.
272 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.
This study's enrollment of 74 is above the median of 60 across 218 interventional studies indexed under Radius Fractures.
Browse Radius Fractures studies →AO Clinical Investigation and Publishing Documentation is the lead sponsor of 49 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: Variable Angle Distal Radius Plate ® (Surgery)
Fracture reduction with distal radius plate
Also known as: 2.4 Variable Angle LCP Two-Column Volar Distal Radius Plate®
Loss of reduction
Loss of reduction will be defined as the change in measurement\* determined to 0.5 mm or 1 degree of accuracy: \*Any change in angles, length or secondary fragment displacement (ie, radial height (length), radial inclination, ulnar variance, gap, step-off, palmar tilt (inclination) / dorsal tilt, scapholunate angle, teardrop angle, and the AP distance).
Time frame: over 1 year
Rate of fracture fixation complications
Time frame: Baseline
Wrist function
Bilateral Range of motion (ROM)
Time frame: 12 weeks
Grip strength
With Jamar dynamometer
Time frame: 12 weeks
Wrist pain and disability in functional activities
Patient self-assessment of wrist function questionnaire (PRWE)
Time frame: Baseline
Quality of Life
Health-related quality of life (EQ5D)
Time frame: Baseline
Implantation and system feedback
Time frame: Baseline
Rate of fracture fixation complications
Time frame: 12 weeks
Rate of fracture fixation complications
Time frame: 1 year
Wrist function
Bilateral Range of motion (ROM)
Time frame: 1 year
Grip strength
With Jamar dynamometer
Time frame: 1 year
Wrist pain and disability in functional activities
Patient self-assessment of wrist function questionnaire (PRWE)
Time frame: 12 weeks
Wrist pain and disability in functional activities
Patient self-assessment of wrist function questionnaire (PRWE)
Time frame: 1 year
Quality of Life
Health-related quality of life (EQ5D)
Time frame: 12 weeks
Quality of Life
Health-related quality of life (EQ5D)
Time frame: 1 year
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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AO Clinical Investigation and Publishing Documentation