2.4 mm Variable Angle LCP Two-Column Volar Distal Radius

Phase 4

Completed

• Conditions: Distal Radius Fractures
• Interventions: Device: Variable Angle Distal Radius Plate ® (Surgery)

• Registration Number: NCT01103297
• Lead Sponsor: AO Clinical Investigation and Publishing Documentation

Brief 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 ®.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Study Start: 2010-06
• Primary Completion: 2014-02
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Variable Angle Distal Radius Plate	Variable Angle Distal Radius Plate ® (Surgery)	-

Primary Outcome Measures

Name	Time	Method
Loss of reduction	over 1 year	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).

Secondary Outcome Measures

Name	Time	Method
Implantation and system feedback	Baseline
Rate of fracture fixation complications	1 year
Wrist function	1 year	Bilateral Range of motion (ROM)
Grip strength	1 year	With Jamar dynamometer
Wrist pain and disability in functional activities	1 year	Patient self-assessment of wrist function questionnaire (PRWE)
Quality of Life	1 year	Health-related quality of life (EQ5D)

Trial Locations

Locations (6)

Charite Berlin; 🇩🇪 Berlin, Germany

Universitätssklinikum Münster; 🇩🇪 Münster, Germany

Spital Zollikerberg; 🇨🇭 Zürich, Switzerland

Unfallkrankenhaus Graz; 🇦🇹 Graz, Austria

Universitätsspital Basel; 🇨🇭 Basel, Switzerland

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland