Overview

This trial is active, not recruiting.

Condition distal radius fractures
Treatment variable angle distal radius plate ® (surgery)
Phase phase 4
Sponsor AO Clinical Investigation and Documentation
Start date June 2010
End date February 2014
Trial size 74 participants
Trial identifier NCT01103297, VALCPDR

Summary

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 ®.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
variable angle distal radius plate ® (surgery) 2.4 Variable Angle LCP Two-Column Volar Distal Radius Plate®
Fracture reduction with distal radius plate

Primary Outcomes

Measure
Loss of reduction
time frame: over 1 year

Secondary Outcomes

Measure
Rate of fracture fixation complications
time frame: Baseline
Wrist function
time frame: 12 weeks
Grip strength
time frame: 12 weeks
Wrist pain and disability in functional activities
time frame: Baseline
Quality of Life
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
time frame: 1 year
Grip strength
time frame: 1 year
Wrist pain and disability in functional activities
time frame: 12 weeks
Wrist pain and disability in functional activities
time frame: 1 year
Quality of Life
time frame: 12 weeks
Quality of Life
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients aged ≥ 18 years - Patients with closed, partial or complete articular distal radius fractures classified as: AO 23 B3 and AO 23 C1, C2, C3 confirmed by CT scan - Definitive primary fracture treatment with a VA LCP DR - The patient is willing and able to participate in the study follow-up examinations according to the protocol - The patient is able to understand and read the local language at an elementary level - The patient or his/her legal guardian is willing and able to give his informed consent to participate in the study - Woman must be one of the following: - Postmenopausal defined as amenorrhea for at least 6 months before screening and a serum follicle stimulating hormone (FSH) level consistent with postmenopausal status - Surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy) - Abstinent (at the discretion of the investigator) or, - If sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, intrauterine device (IUD), a double-barrier method such as condoms, diaphragms or cervical caps with spermicidal foam, cream or gel, or male partner with a vasectomy. - Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test, or a negative urine pregnancy test at screening. Exclusion Criteria: - Previous ipsilateral distal radius fracture - Other fractures of the ipsilateral side (except ulna) - Pathologic fracture due to malignancy - The patient suffers from a polytrauma - The patient is affected by drug or alcohol abuse - The patient suffers from active malignancy - Neurological and psychiatric disorders - The patient has participated in any other device or drug related clinical trial within the previous month - The patient is a prisoner - Breast feeding woman

Additional Information

Official title A Prospective Multicenter Case-series of Patients Treated With the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®
Principal investigator Jesse B Jupiter, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by AO Clinical Investigation and Documentation.