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2.4 mm Variable Angle LCP Two-Column Volar Distal Radius (VALCP2010)

Primary Purpose

Distal Radius Fractures

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Variable Angle Distal Radius Plate ® (Surgery)
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures focused on measuring Distal radius fracture, Double row plate, Volar approach, DVR plate, Postoperative complications [MeSH]

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unfallkrankenhaus Graz
  • Charite Berlin
  • Universitätssklinikum Münster
  • Universitätsspital Basel
  • Luzerner Kantonsspital
  • Spital Zollikerberg

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Variable Angle Distal Radius Plate

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
March 25, 2010
Last Updated
September 18, 2014
Sponsor
AO Clinical Investigation and Publishing Documentation
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1. Study Identification

Unique Protocol Identification Number
NCT01103297
Brief Title
2.4 mm Variable Angle LCP Two-Column Volar Distal Radius
Acronym
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 ®
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO Clinical Investigation and Publishing Documentation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
Distal radius fracture, Double row plate, Volar approach, DVR plate, Postoperative complications [MeSH]

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Variable Angle Distal Radius Plate
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Variable Angle Distal Radius Plate ® (Surgery)
Other Intervention Name(s)
2.4 Variable Angle LCP Two-Column Volar Distal Radius Plate®
Intervention Description
Fracture reduction with distal radius plate
Primary Outcome Measure Information:
Title
Loss of reduction
Description
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
Secondary Outcome Measure Information:
Title
Rate of fracture fixation complications
Time Frame
Baseline
Title
Wrist function
Description
Bilateral Range of motion (ROM)
Time Frame
12 weeks
Title
Grip strength
Description
With Jamar dynamometer
Time Frame
12 weeks
Title
Wrist pain and disability in functional activities
Description
Patient self-assessment of wrist function questionnaire (PRWE)
Time Frame
Baseline
Title
Quality of Life
Description
Health-related quality of life (EQ5D)
Time Frame
Baseline
Title
Implantation and system feedback
Time Frame
Baseline
Title
Rate of fracture fixation complications
Time Frame
12 weeks
Title
Rate of fracture fixation complications
Time Frame
1 year
Title
Wrist function
Description
Bilateral Range of motion (ROM)
Time Frame
1 year
Title
Grip strength
Description
With Jamar dynamometer
Time Frame
1 year
Title
Wrist pain and disability in functional activities
Description
Patient self-assessment of wrist function questionnaire (PRWE)
Time Frame
12 weeks
Title
Wrist pain and disability in functional activities
Description
Patient self-assessment of wrist function questionnaire (PRWE)
Time Frame
1 year
Title
Quality of Life
Description
Health-related quality of life (EQ5D)
Time Frame
12 weeks
Title
Quality of Life
Description
Health-related quality of life (EQ5D)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse B Jupiter, MD
Organizational Affiliation
Massachusetts General Hospital, Orthopaedic Surgery, Yawkey Center, Suite 2100, 55 Fruit Street, Boston, MA 02114, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Schierz, MD
Organizational Affiliation
Spital Zollikerberg, Unfallchirurgie, Trichtenhauserstrasse 20, CH-8125 Zollikerberg, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unfallkrankenhaus Graz
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Charite Berlin
City
Berlin
Country
Germany
Facility Name
Universitätssklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4056
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Spital Zollikerberg
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

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2.4 mm Variable Angle LCP Two-Column Volar Distal Radius

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