2.4 mm Variable Angle LCP Two-Column Volar Distal Radius

Distal Radius Fractures Clinical Trial

— VALCP2010  

Official title:

A Prospective Multicenter Case-series of Patients Treated With the 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plate ®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103297
• Other study ID #: VALCPDR
• Status: Completed
• Phase: Phase 4
• First received: March 25, 2010
• Last updated: September 18, 2014
• Start date: June 2010
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: AO Clinical Investigation and Documentation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionGermany: Federal Office for Radiation ProtectionGermany: Federal Institute for Drugs and Medical DevicesAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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 ®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-human chorionic gonadotropin (ß-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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fractures
• Radius Fractures

Intervention

Device:
• Variable Angle Distal Radius Plate ® (Surgery)
Fracture reduction with distal radius plate

Locations

Country	Name	City	State
Austria	Unfallkrankenhaus Graz	Graz
Germany	Charite Berlin	Berlin
Germany	Universitätssklinikum Münster	Münster
Switzerland	Universitätsspital Basel	Basel
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	Spital Zollikerberg	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Documentation

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	over 1 year	No
Secondary	Rate of fracture fixation complications		Baseline	No
Secondary	Wrist function	Bilateral Range of motion (ROM)	12 weeks	No
Secondary	Grip strength	With Jamar dynamometer	12 weeks	No
Secondary	Wrist pain and disability in functional activities	Patient self-assessment of wrist function questionnaire (PRWE)	Baseline	No
Secondary	Quality of Life	Health-related quality of life (EQ5D)	Baseline	No
Secondary	Implantation and system feedback		Baseline	No
Secondary	Rate of fracture fixation complications		12 weeks	No
Secondary	Rate of fracture fixation complications		1 year	No
Secondary	Wrist function	Bilateral Range of motion (ROM)	1 year	No
Secondary	Grip strength	With Jamar dynamometer	1 year	No
Secondary	Wrist pain and disability in functional activities	Patient self-assessment of wrist function questionnaire (PRWE)	12 weeks	No
Secondary	Wrist pain and disability in functional activities	Patient self-assessment of wrist function questionnaire (PRWE)	1 year	No
Secondary	Quality of Life	Health-related quality of life (EQ5D)	12 weeks	No
Secondary	Quality of Life	Health-related quality of life (EQ5D)	1 year	No